INTRODUCTION:

The alveolar bone loss which resulted from traumatic tooth extraction, severe periodontitis or tumor surgery without alveolar ridge preservation makes implant treatment more challenging with compromised esthetics and overall treatment prognosis^1,2. Moreover, the routine hygiene care around the prosthesis may be difficult^3,4.

Therefore, ridge preservation using bone graft substitutes is performed to avoid bone resorption^5,6. In spite of minimizing the ridge resorption, it can facilitate subsequent placement of an implant which provides more satisfactory outcome in terms of esthetic and function^{7, 8}.

The four basic categories of bone grafting materials, including autograft, allograft, xenograft, and alloplastic graft are used during surgery. Several characteristics such as good scaffolding for osteoconduction, containing growth factors for osteoinduction and progenitor cells for osteogenesis make the Autografts as the gold standard for bone augmentation. Generally, the risk of donor site morbidity for Autografts and disease transmission and immunologic reactions for both Allografts and xenografts should be taken into account using these materials⁹. Therefore, there is an increasing interest in the use of alloplastic (synthetic) grafting materials and according to hitomorphometric investigations, they can be successfully used for bone grafting^10,11. These include bioactive glass, Hydroxyapatite (HA) and β-tricalcium Phosphate (β-TCP).

The most widely used bioceramics material for bone grafting in humans is HA, which has a chemical composition and crystalline structure similar to bone^12,13. HA and some other calcium-based ceramic materials can be regarded as bioactive materials since they allow apposition and migration of osteoblasts at the material surface due to osteoconductive properties. HA is known to be able to bond directly to bone and other living tissue without creating a collagen layer which makes it a favorable bioactive material. HA alone or combined with other grafts has been shown promising clinical success rates in dentistry and maxillofacial surgery to support alveolar bone regeneration^14-16. It can provide favorable properties such as biocompatibility, biodegradability, osteoconductivity and low cytotoxicity and also is available in a wide variety of forms (powders, porous blocks, or beads)^17,18.

A HA/β-TCP is a bone-graft substitute produced to prevent clustering and to establish a new homogeneous molecule with porosity to support the cellular penetration. The promising outcome has been shown when the surfaces of implants coated with this osteoconductive bio material. The main advantage of this material is that it is an excellent cell carrier of mesenchymal stem cells which help to promote bone formation¹⁹.

OsvehOss® is a synthetic bone graft substitute containing 60% β-TCP and 40% of HA. This biomaterial produced with different shapes such as granules, powders, sticks, blocks and cylinders in several sizes. This material successfully surpassed the laboratory and animal studies and now available for human evaluations²⁰.

To the best of our knowledge, there was only one study in which OsvehOss® bone grafts was used as a substitute for autogenous iliac crest bone graft to promote spine fusion. Based on radiography results, this allograft showed higher ossification and fusion rate after one and three months later post-operative based on compared with the similar product²⁰.

MATERIAL AND METHODS:

This prospective case series was approved by the Mashhad University of Medical Sciences Ethics committee, Iran (No: 2877). This study was conducted in the Perdiodontology department of the Mashhad dental school. The healthy patients who need a tooth extraction due to non-restorable or advanced caries, or teeth with severe fractures or endodontic treatment failures were included in this research. Those who need osseous destruction during the tooth extraction were also included.

The participants who suffered from systemic or chronic diseases, allergy, alcoholism and drug abuse or those who had a history of active infections and periodontal disease localized in the proximity of the prospective surgical field as well as the smokers, pregnant women or those during the lactating period were excluded from the study. Moreover, the patients who experienced radiotherapy or chemotherapy as a result of malignant diseases during the past 5 years were excluded.

Each patient received sufficient explanations regarding the study purpose, ingredients of OsvehOss®, treatment and surgery procedure, three assessments and possible complications. The surgery was performed once the patient signed the informed consent. A total of twenty patients met the inclusion criteria and recruited to the study.

Surgical procedure:

All surgical procedures were performed by one expert surgeon. Extraoral preparation was carried out with povidone-iodine solution (Behsa Co., Arak, Iran). The patients were asked to rinse their mouth with 0.2% chlorhexidine gluconate mouthwash (Iran NAJO, Tehran, Iran) for about 2 min. After the administration of local anesthesia, atraumatic extraction of the hopeless teeth were done with the help of periotome and elevators (JUYA, Istanbul, Turkey). After the extraction, surgical curette was used to debride the socket thoroughly to the removal of soft tissue fragments and infected granulation tissue, followed by irrigation and rinsing with sterile saline (Figure 1). The proper amount of OsvehOss® granules (Ossveh Asian Medical Instruments Co, Mashhad, Iran) was mixed with fresh blood oozing from the socket. This makes the particles cohesive and was placed easily inside the socket in increments up to the level of the alveolar crest (Figure 2). Attention was given not to overfill the extraction socket to avoid any displacement of the entire graft mass after mechanical irritation during the first phases of healing. A saline-wet gauze was used to further compact the granules and accelerate the hardening of the graft in situ so that after a few minutes the alloplastic bone substitute formed a stable, solid, porous scaffold.

To facilitate the healing process, a figure eight tension-free nonresorbable 4-0 sutures (Black Silk, Ethicon, Johnson & Johnson, NJ, USA) was placed over the filled socket to achieve soft tissue stability (Figure 3). The patients were requested not to wear any prosthesis during the healing period.

To reduce post-operative pain and infections, systemic antibiotic, and analgesic medicine were prescribed which included amoxicillin 500 mg capsules every 8 h for 5 days, Paracetamol 500 mg tablets in the case of occurrence of the pain and 0.12% chlorhexidine gluconate mouth rinse for 2 weeks.

Each patient was requested to evaluate after 24, 48 of the operations in terms of the following clinical parameters: 1. Severe unwanted allergic reactions, such as erythema, 2. The presence of sinus tract, 3. Severe swelling of the attached gingiva which extended to the alveolar mucosa, 4. Opening of stitches, 5. Fever, 6. Color change of soft tissue, 7. Infection in the tooth extraction site, 8. Severe pain that does not respond to the usual Non Steroidal Anti-Inflammatory Drugs (NSAID) protocol.

After one week, the sutures removed and the patient was investigated for the last measurement (Figure 4).

Figure 1. The tooth socket immediately after the extraction.

Figure 2. The socket preservation using OsvehOss® granules (Ossveh Asian Medical Instruments Co, Mashhad, Iran).

Figure 3. The fixing of the bio material with figure 8 shaped sutures.

Figure 4. The assessment of the extraction sites after 1 week post-surgery.

Statistical analysis:

The normal distribution of all scores was assessed using the Kolmogorov–Smirnov test. Differences between the men and women's groups were assessed using t-test. The measurement was carried out using SPSS 21.0 statistical software (SPSS Inc., Chicago, IL, USA). Statistical significance was set at with a level of P < 0.05%.

RESULTS:

In this case series, twenty patients containing 14 women (70%) and 6 men (30%) participated. The whole participants completed the three measurements. The minimum and maximum age of the participants in this study was 22 and 58 years, respectively. The mean age of the participants was 36.65 with the standard deviation of 12.65 years. The age distribution of the participants of this study demonstrated in figure 5.

Figure 5. The histogram of the age distribution of the participants in this case series.

Based on the Kolmogrov-Smirnov test, the data of the age showed normal distribution (P>0.05). Despite the fact that the average age of women was 7 years higher than men, the t-test analysis showed no significant difference between the mean age of women and men (P = 0.201) (Table 1).

Table 1. The comparison of mean age of male and female in this study.

Variable

Gender

Number

Mean

Confidence interval

T-test value

Age

Female

38.71

13.78

T=1.34

P=0.201

Male

31.83

8.77

As presented in table 2, there was only one participant form women (7.1%) and one subject from men (16.7%) who showed the symptoms of infection in the whole three measurements. Therefore, there was no statistically significant correlation between gender and infection (p = 0.521).

None of the other clinical variables, including fever, severe swelling, soft tissue color change, allergic reaction, severe pain, stitch opening and sinus tract was reported positive among all participants within the study follow up period. So, there was no need for additional statistical tests.

Table 2. The rate and percent of infection in both male and females after the surgery in this research.


			Post/pre-surgical infection		Total
			Positive	Negative	Total
Gender	Female	Number	1	13	14
	Female	Percent	7.1%	92.9%	100%
	Male	Number	1	5	6
	Male	Percent	16.7%	83.3%	100%
Total		Number	2	18	20
Total		Percent	10 %	90%	100%

DISCUSSION:

The long-term success of osseointegrated implant along with the satisfactory esthetic outcome can be achieved when applied to alveolar ridge preservation after extraction. Indeed, the socket without graft has revealed significant resorption rate in both vertical as well as buccolingual dimensions, which negatively affect the success of implant^2,21,22. Based on literature, an average of 40% to 60% of an original height and width is expected to be lost, especially within the initial three months after extraction²³.

Synthetic or Alloplastic grafts (Artificial bone grafts) generally consist of different forms of calcium and phosphate, such as HA and β-TCP. Since, these materials are completely synthetic, there is no donor inconvenience, neither amount limitations nor possibility of transmitting diseases.

The autogenous grafts are still considered the golden standard for grafting procedures since they resulted in a high rate of new bone regeneration, followed by allogenic demineralized bone matrix^24,25. The β-TCP containing bone graft is a synthetic alloplastic material, has been successfully used with satisfactory clinical and histological results in both animal models and human trials. The β-TCP is a resorbable osteoconductive material, which is expected to be resorbed within 3-6 months after placement and will be replaced by newly mineralized bone tissue without fibrous tissue proliferation. Biodegradation of β-TCP particles occurs by chemical dissolution by tissue fluids and also by osteoclast cells²⁶. The β-TCP graft is an ideal bone replacement bio material at the time of tooth extraction which showed complete regeneration²⁷. In line with these statements, a previous case report reported the formation of an adequate volume of alveolar bone after using the β-TCP bone graft for ridge augmentation by clinical and radiographical evidences. The formation of proper amount of bone permitted the placement of desired dimensions of the implant with superior esthetic results².

Although the β-TCP bone graft revealed favorable outcome in socket preservation, but it seems HA bone substitute grafting interfered with the normal healing process, especially in sinus augmentation²⁸. Therefore, it is better to combine HA with autologous grafts or with other biomaterials for ridge reservation. The findings of a study by Ioku et al.²⁹ was consistent with aforementioned statements which revealed the better advantages of β-TCP (OSferion, Olympus®, Tokyo, Japan) than HA (Neobone®, MMT, Osaka, Japan) for bone regeneration in dogs. In their study, the greater bone mass in earlier time produced in β-TCP treated group while no increase was noted in HA treated group after 8 weeks.

One disadvantage of HA is the durability of the material for a prolonged period. Although it can be increased the rate of fracture of the repaired bone, but it also produces a scaffold for new bone formation and osteoconduction. On the other hand, it can create a space which prevents the entrance of the soft tissue cells into the defect during bone formation; a favorable characteristic in the oral cavity²⁹.

To enhance its biological and mechanical performance, β-TCP has been combined with other compounds such as HA. This combination increases the porosity of the grafting material, accelerated the osteogenes, prevents epithelial down growth during new bone formation, enhances graft stability and improve the bone quality in some materials such as calcium sulfate (Fortoss Vital, Biocomposites, Staffordshire, United Kingdom)²³. It has been shown the use of HP/β-TCP appears to be more efficient in osteoconduction when compared with of HA and β-TCP alone and could be a promising strategy for preservation of alveolar sockets³⁰. The results of a previous study by Kakar et al.⁸ showed that grafting of post-extraction sockets using a HA/β-TCP results in an effective preservation of the ridge contour and sufficient new bone formation in the grafted sites, which is imperative for successful implant placement.

The combination of HA with TCP is expected to achieve improved characteristics owing to the differential effects of these two components on the regeneration process. HA can provide a cell matrix and improve the mechanical strength of the material, whereas TCP can influence the earlier stages of bone formation by creating an optimal environment before being absorbed. This combination provides several additional advantages, including the absence of donor morbidity, biocompatibility due to the chemical similarity of the materials with the host bone and lack of inflammatory reactions. Additionally, by controlling the proportion of each component, the bioactivity and biodegradation could be manipulated³¹.

To the best of our knowledge, there was only one study in which OsvehOss® bone grafts were used as a substitute for autogenous iliac crest bone graft to promote spine fusion in the patients diagnosed with L4-L5 degenerated spondylolisthesis. In this single blind random assigned clinical trial study, the authors compared OsvehOss® bone grafts versus synthetic bone grafts with similar structure. Based on their results, OsvehOss® bone grafts showed higher ossification and fusion rate after one and three months later post-operative compared with the similar product, with no complications²⁰. Although this study revealed no clinical complication after using the OsvehOss® bone graft in socket preservation, but this case series was a pilot study and further studies with larger sample sizes should be conducted to investigate the use and efficacy of this product and its success in bone formation.

The other HA/β-TCP containing biomaterial (Strauman, Basel, Switzerland) which has a homogeneous composition of HA and β-TCP with a ratio of 60 to 40 similar to OsvehOss®, presented the excellent osteoconductivity. Indeed, the quick absorbance of β-TCP leads to an aggregation of calcium and Phosphate and bone formation, whilst HA which has a slower absorbance preserves the scaffold and sustains space for bone formation³².

According to the present study, there were no post-operative complications related to OsvehOss® grafting except infection in two patients; one man and another woman. For these patients, after one week, the socket was inspected and the bone constitutes were removed. After irrigation, the new biomaterial was inserted for the second time. After one weak the inflammation was completely disappeared.

The favorable clinical outcome of the current study regarding the use of HA/β-TCP containing biomaterial for ridge augmentation was in agreement with a previous showed the HA/β-TCP or HA/β-TCP resulted in a remarkable amount of newly formed bone after a 5-month healing period when it used for sinus maxillary augmentation¹⁵. In agreement another study revealed the higher percentage of new vital bone formation in the group grafted with HA/β-TCP+HY (Osteon, Genoss, Korea) compared with one of them alone after 8 weeks postoperative in rabbits³⁰. The composition of Osteon is similar to OsvehOss® to some extent. Osteon composed of 70% HA and 30% β-TCP which are closest to the major mineral components of human bone, and have an interconnected porosity structure (scaffolding) which is similar to that of human cancellous bone³³.

One of the main limitations of this study was the lack of radiographic and histopathologic evaluations which confirmed the healing process of bone. The authors of the current study suggested the randomized controlled clinical trials to compare the different types of bone substitutes with OsvehOss® in future research. Yet, it is important to note that this is the first prospective case series demonstrating effectiveness of OsvehOss® in ridge preservation at an extraction socket for implant site development.

CONCLUSION:

Within the limitations of this study, OsvehOss® can be a good attractive option to patients who are in need of tooth extraction and alveolar ridge augmentation for further implant placement.

ACKNOWLEDGEMENT:

This article was extracted from a thesis with 2877 number carried out in 2017 at the Dental School of Mashhad University of Medical Sciences, Iran, under the advisory guidance of Dr. Radvar. The authors would like to extend their gratitude to the Vice-Chancellor of Research of Mashhad University of Medical Sciences for providing the financial support for this project.

CONFLICT OF INTEREST:

The authors of this manuscript certify that they have no financial or professional interests related to topics presented in this manuscript.

REFERENCES:

1. Vidhya T, Murugan T. Attitude of General Dental Practitioners towards Periodontal Treatment. Research Journal of Pharmacy and Technology. 2018;11(3):930-2.

2. Bhatt AK, Pant VA, Pandey M. Alveolar Ridge Preservation with Beta-Tricalcium Phosphate Bone Graft and Implant Placement: A Case Report. IJSS case reports and reviews. 2015;1(11):28-31.

3. Jyothi S, Robin PK, Ganapathy D. Periodontal health status of three different groups wearing temporary partial denture. Research Journal of Pharmacy and Technology. 2017;10(12):4339-42.

4. Kim Y-K, Yun P-Y, Um I-W, Lee H-J, Yi Y-J, Bae J-H, et al. Alveolar ridge preservation of an extraction socket using autogenous tooth bone graft material for implant site development: prospective case series. The journal of advanced prosthodontics. 2014;6(6):521-527.

5. Meenakshi SS, Malaiappan S. Knowledge, Attitude and Practice of Placing Periodontal Dressing (to pack or not to pack) among Periodontists. Research Journal of Pharmacy and Technology. 2019;12(2):799-804.

6. Cosso MG, de Brito Jr RB, Piattelli A, Shibli JA, Zenóbio EG. Volumetric dimensional changes of autogenous bone and the mixture of hydroxyapatite and autogenous bone graft in humans maxillary sinus augmentation. A multislice tomographic study. Clinical oral implants research. 2014;25(11):1251-1256.

7. Bagde AD, Jaju S, Patil P. A review on FEM analysis of mandibular overdenture implant. International Journal of Innovative Research Science Engneering Technology. 2013;2(6):2137-44.

8. Kakar A, Rao BHS, Hegde S, Deshpande N, Lindner A, Nagursky H, et al. Ridge preservation using an in situ hardening biphasic calcium phosphate (β-TCP/HA) bone graft substitute—a clinical, radiological, and histological study. International journal of implant dentistry. 2017;3(1):25.

9. Buser D, Dula K, Hirt HP, Schenk RK. Lateral ridge augmentation using autografts and barrier membranes: a clinical study with 40 partially edentulous patients. Journal of oral and maxillofacial surgery. 1996;54(4):420-432.

10. Molly L, Vandromme H, Quirynen M, Schepers E, Adams JL, van Steenberghe D. Bone formation following implantation of bone biomaterials into extraction sites. Journal of periodontology. 2008;79(6):1108-1115.

11. Kattimani VS, Prathigudupu RS, Jairaj A, Khader MA, Rajeev K, Khader AA. Role of Synthetic Hydroxyapatite—In Socket Preservation: A Systematic Review and Meta-analysis. The Journal of Contemporary Dental Practice. 2019;20(8):988-993.

12. Singh S, Pal A, Mohanty S. Nano Structure of Hydroxyapatite and its modern approach in Pharmaceutical Science. Research Journal of Pharmacy and Technology. 2019;12(3):1463-72.

13. Šupová M. Problem of hydroxyapatite dispersion in polymer matrices: a review. Journal of Materials Science: Materials in Medicine. 2009;20(6):1201-1213.

14. Mangano C, Scarano A, Perrotti V, Iezzi G, Piattelli A. Maxillary sinus augmentation with a porous synthetic hydroxyapatite and bovine-derived hydroxyapatite: a comparative clinical and histologic study. International Journal of Oral & Maxillofacial Implants. 2007;22(6):980-986.

15. Kühl S, Götz H, Brochhausen C, Jakse N, Filippi A, Kreisler M. The influence of substitute materials on bone density after maxillary sinus augmentation: a microcomputed tomography study. International Journal of Oral & Maxillofacial Implants. 2012;27(6):1541-1546.

16. Mangano C, Piattelli A, Mangano A, Mangano F, Mangano A, Iezzi G, et al. Combining scaffolds and osteogenic cells in regenerative bone surgery: a preliminary histological report in human maxillary sinus augmentation. Clinical implant dentistry and related research. 2009;11:e92-e102.

17. Girija C, Sivakumar M. Amalgamation and Characterization of Hydroxyapatite Powders from Eggshell for Functional Biomedical Application. Research Journal of Pharmacy and Technology. 2018;11(10):4242-4.

18. Arts JC, Verdonschot N, Schreurs BW, Buma P. The use of a bioresorbable nano-crystalline hydroxyapatite paste in acetabular bone impaction grafting. Biomaterials. 2006;27(7):1110-1118.

19. Trojani C, Boukhechba F, Scimeca J-C, Vandenbos F, Michiels J-F, Daculsi G, et al. Ectopic bone formation using an injectable biphasic calcium phosphate/Si-HPMC hydrogel composite loaded with undifferentiated bone marrow stromal cells. Biomaterials. 2006;27(17):3256-3264.

20. Safaie YA, Houshyar AA, Sasani N, Khadivi AH, Golestanipour M, Moloudi A, et al. Biocompatibility Evaluation And Clinical Investigation of Novel Synthetic Bone Graft Substitute, Osvehoss® A Prospective, Randomized Study with A 6-Month Follow-UP. 2016;2.

21. Nevins M, Camelo M, De PS, Friedland B, Schenk RK, Parma-Benfenati S. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Primary Dental Care. 2006(3):90.

22. Rezkita F, Wibawa KG, Nugraha AP. Curcumin loaded Chitosan Nanoparticle for Accelerating the Post Extraction Wound Healing in Diabetes Mellitus Patient: A Review. Research Journal of Pharmacy and Technology. 2020;13(2):1039-42.

23. Leventis MD, Fairbairn P, Dontas I, Faratzis G, Valavanis KD, Khaldi L, et al. Biological response to β-tricalcium phosphate/calcium sulfate synthetic graft material: an experimental study. Implant Dentistry. 2014;23(1):37-43.

24. Arenaz-Búa J, Luaces-Rey R, Sironvalle-Soliva S, Otero-Rico A, Charro-Huerga E, Patiño-Seijas B, et al. A comparative study of platelet-rich plasma, hydroxyapatite, demineralized bone matrix and autologous bone to promote bone regeneration after mandibular impacted third molar extraction. Medica Oral Patolologia Oral y Cirugia Bucal. 2010;15(3):e483-489.

25. Shakibaie-M B. Comparison of the effectiveness of two different bone substitute materials for socket preservation after tooth extraction: a controlled clinical study. International Journal of Periodontics & Restorative Dentistry. 2013;33(2):222-228.

26. Tal H, Artzi Z, Kolerman R, Beitlitum I, Goshen G. Augmentation and preservation of the alveolar process and alveolar ridge of bone. Bone Regeneration. 2012:139-184.

27. Al-Fhdawi LS. Tooth Socket Preservation Using Beta Tricalcium Phosphate (β-TCP) Clinical and Experimental Studies. Al-Anbar Medical Journal. 2015;12(1):13-25.

28. Dewi AH, Ana ID. The use of hydroxyapatite bone substitute grafting for alveolar ridge preservation, sinus augmentation, and periodontal bone defect: A systematic review. Heliyon. 2018;4(10):e00884.

29. Ioku Y, Haeniwa H, Kakudo K. Effect of β-tricalcium phosphate and porous hydroxyapatite bone substitutes on bone regeneration in alveolar bone defects around dental implants. Journal of Oral and Maxilofacial Surgery. 2015;49:69-84.

30. ELkarargy A. Alveolar sockets preservation using hydroxyapatite/beta tricalcium phosphate with hyaluronic acid (histomorphometric study). Journal of American Science. 2013;9(1):556-563.

31. Wang T, Li Q, Zhang G-f, Zhou G, Yu X, Zhang J, et al. Comparative evaluation of a biomimic collagen/hydroxyapatite/β-tricaleium phosphate scaffold in alveolar ridge preservation with Bio-Oss Collagen. Frontiers of Materials Science. 2016;10(2):122-133.

32. Von Arx T, Cochran DL, Hermann JS, Schenk RK, Higginbottom FL, Buser D. Lateral ridge augmentation and implant placement: an experimental study evaluating implant osseointegration in different augmentation materials in the canine mandible. International Journal of Oral & Maxillofacial Implants. 2001;16(3):343-354.

33. Kim YK, Yun PY, Lim SC, Kim SG, Lee HJ, Ong JL. Clinical evaluations of OSTEON® as a new alloplastic material in sinus bone grafting and its effect on bone healing. Journal of Biomedical Materials Research Part B: Applied Biomaterials: An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials and the Korean Society for Biomaterials. 2008;86(1):270-277.

Received on 11.04.2020 Modified on 13.10.2021

Research J. Pharm. and Tech 2022; 15(11):5126-5131.

DOI: 10.52711/0974-360X.2022.00862