Comparative Evaluation of Adjunctive Use of Locally Delivered Tetracycline Fiber (Actisite) With Scaling and Root Planning in the Treatment of Chronic Periodontitisa Clinical Study

 

1Dr. Jiji John, 2Dr Pamela Emmadi, 3Dr. N. Ambalavanan, 4Dr Esha Verma

1Professor & Head of the Department of Periodontics, Department of Periodontics & Oral Implantology, College of Dental Science and Hospital, F-12 Jhoomer Ghat (Near Hotel Mashal) Rau, Indore ,Madhya Pradesh 453331

2Professor & Head of the Department of Periodontics, Meenakshi Ammal Dental College, Chennai – 602102.

3Professor, Department of Periodontics, Meenakshi Ammal Dental College, Chennai – 602102.

4Senior Lecturer, Department of Periodontics & Oral Implantology, College of Dental Science and Hospital,

F-12 Jhoomer Ghat (Near Hotel Mashal),  Rau, Indore ,Madhya Pradesh. 453331

*Corresponding Author E-mail: john.j072@gmail.com

 

 

ABSTRACT:

The aim of the study was to make comparative evaluation of adjunctive use of locally delivered tetracycline fiber (Actisite) to scaling and root planning and to compare it with SRP alone in the treatment of chronic periodontitis. Fifteen patients, aged 30-55 years having chronic periodontitis with periodontal pockets 5-8 mm were selected for the study. Two sites for each subject comprising site A and site B with a total of 30 sites. Clinical parameters like Plaque index, Gingival index, Sulcus bleeding index, Probing pocket depth, Clinical attachment level were recorded at baseline, 10th day, 45th day and 60th day post operatively. The result of the study showed that the use of tetracycline fibers along with scaling and root planning doses not offer any advantage once scaling and root planing alone excepting only for a marginal benefit in clinical parameter and gingival inflammation. The effect of mechanical debridement seems to have greater effect on the clinical outcome thus over shadowing the antimicrobial activity of tetracycline

 

KEYWORDS:

 


INTRODUCTION:

Inflammatory periodontal disease may be viewed as an infection induced by a variety of microbes or combinations thereof that can progress in cyclic brusts of disease activity that may be generalized or site specific.1

 

It is well known that periodontal disease is the result of a local bacterial infection with a pathogenic microflore within the periodontal pocket.2 Various methods employed for the effectiveness of antimicrobial agents into periodontal pocket include the rinsing, irrigation, systemic administration and local application of local drug delivery system using in a sustained and control delivery system have resulted in a number of site specific controlled release methods which have received great interest and appear to hold promising in the success of periodontal theory­­.3

 

Success of any drug delivery system designed to target periodontal infections depends upon its ability to deliver the drug to infected sites as effective concentrations to the base of pocket at a bacteriostatic on bactericidal level.3,4

 

Tetracycline fiber is an antimicrobial agent. It is primarily bacterio- static with broad antibacterial activity and has a wide spectrum of activity that are effective against gram-negative species including putative periodontal pathogen such as AA and also against many anaerobic and facultative bacteria.

 

In this study, the controlled drug delivery system used is tetracycline fiber (ACTISITE) containing 12.7 mg of tetracycline hydrochloride and 25% of polymer ethylene vinyl acetate.5

 

MATERIALS AND METHODS:

15 patients (7 males and 8 females) aged 30-55 yrs. (using split arch design) with chronic periodontitis and without any systemic problems. A total of 30 sites in which each patient, two sites but on identical contralateral teeth having periodontal pockets 5-8mm were selected for the study.

 

Control Sites A     Scaling and root planning without tetracycline fiber

(15 Sites)               placement.

Test Sites B           Scaling and root planing plus tetracycline fiber

(15 Sites)               placement.

 

All the patients were informed about their benefits` and consent was obtained before the procedure. In general full mouth periodontal examinations were carried out at a screening visit which was scheduled not more than 2 weeks prior to baseline visit. A complete full mouth supragingival scaling was performed at the screening visit, followed by impression for the fabrication of acrylic stent Figure 2 which were used for measuring clinical parameters was recorded. SRP were done using ultrasonic scalar and hand instruments. Root planning was performed under local anesthesia. After completion of SRP, Figure 1 tetracycline fiber was inserted into the pocket of the test site. Figure 3,4 The post operative clinical parameter evaluation was done at baseline 0 day, 10th day, 45th day and 60th day.

 

EXPERIMENTAL PARAMETERS:

Clinical parameters:-

1.      Plaque Index

2.      Gingival Bleeding Index

3.      Sulcus Bleeding Index (Muhlemann and Son 1971)

4.      Probing Pocket Depth.

5.      Clinical Attachment Level.

 

STATISTICAL ANALYSIS:

The data were observed from the patients and were divided into a control site and test site (experimental) on various parameters as listed earlier. Based on these data, the two treatment forms were compared using their means.

 

The student ‘t’ test was used to test the significance of mean changes at different time intervals. The significance of those parameters was tabulated.

 

RESULT:

Fifteen patients aged between 30-55 yrs, diagnosed as chronic periodontitis were included in the study. Statistical evaluation of clinical observation yielded the following results.

 

Table 1 (A) and (B) shows the mean and S.D. of pre and post treatment plaque scores at different time point and its significances.

 

The plaque scores decreased within sites at different time points and showed highly significant but when compared between control and test group it was found to be not statistically significant.

 

Table 2 (A) and (B) shows the mean and S.D. of pre and post treatment gingival score within sites at different time points and its significance. The gingival scores reduced within sites at different time point and showed highly significant but when compared between control and test group it was found not to be statistically significant.

 

Table 3 (A) and (B) shows the mean and S.D. of pre and post treatment sculcus bleeding within sites at different time points and showed highly significant but when compared between control and test group it was found to be highly significant between 0 to 60th day.

 

Table 4 (A) and (B) shows the mean and S.D. of pre and post treatment of probing pocket depth within sites at different time point and its significance. The pocket showed reduced probing pocket depth within sites at different time pints but when compared between control and test group it was found to be not statistically significant.

 

Table 5 (A) and (B) shows the mean and S.D. of pre and post treatment of gain of Clinical attachment level within sites at different time point and its significance. The gain in clinical attachment level within sites at different point showed highly significant but when compared between control and test group it was found to be not statistically significant.

 

DISCUSSION:

The present study was assessed to evaluate the clinical effects of controlled release local drug delivery tetracycline fiber (Actisite) containing 12.7mg. when used as an adjunct to scaling and root planing in the treatment of chronic periodontitis. The study showed there was significant difference from 0 to 45th and 0 to 60th day in all the clinical parameter in control and test group but no significant differences between the two treatment sites were found regardless of whether combined antimicrobial mechanical theory was performed, except for sulcus bleeding index which shows a significant difference from 0 day to 60th day.6,7

 

There was a significant improvement of plaque scores and gingival bleeding between baseline to 45th day and 0-60th day.8 Table 1(A),(B)

 

The present study is also in agreement with that of Newmen MG etal (1994) found a significant improvement in bleeding on probing in pockets treated with scaling and root planing and tetracycline fiber at different time points.9.10 Table 3(A), (B).

 

The treatment of periodontal pocket with tetracycline fiber found that sites treated with SRP and tetracycline fiber was an effective as SRP alone in improvement of probing pocket depth and gain in Clinical attachment of  level with no significant difference among treatments.8,11Table4 (A),(B),Table 5(A)(B)

 

The result of this study is consistent with the study done by Kerry G (1994) that showed Probing pocket depth declined substantially from baseline to 60th day in patients treated with SRP plus tetracycline fiber.11 This was also coinciding with the findings of Drisko et al who reported that tetracycline fibers versus SRP attained probing depth reductions that were not statistically significantly different at sites initially ≥ 7mm.12

 

The above findings of the study shows that the use of tetracycline fibers along with scaling and root planning does not offer any advantage over SRP alone, except for a marginal benefit of resolution of all the clinical parameter at different time interval but when compared between control and test group it showed nothing statistically significant. According to Garry Greenstein the study is compared the efficacy of local and systemic drug delivery was directly compared among individuals with chronic periodontitis, they found out the results were not statistically significant. Here the study have been compared around 6 to 9 months which is insufficient to get statistically significant results.13 This emphasizes the importance of mechanical therapy in the form of sub gingival debridment and root planning. However the limitations of this study should be borne in mind and further studies with an increased number of sites, a longer follow up period and immunologic and microbiologic researches should be taken into consideration and which will be able to get greater improvement in microbiological parameters when used as an adjunct to mechanic therapy as compared to SRP alone in the treatment of chronic periodontitis. 

 

SUMMARY AND CONCLUSION:

The objective of the present study was to evaluate the adjunctive use of tetracycline fiber (Actisite) to scaling and root planning and to compare it with SRP alone in periodontal sites of 5-8 mm in patients with chronic periodontitis.

 

The present study was undertaken to determine the efficacy of a local drug delivery tetracycline fiber (Actisite) when used as an adjunct to scaling and Root planing in the treatment of chronic periodontitis.

 

The following conclusions were drawn from the result of the study.

1.      There was a statistically significant difference in Plaque index. Gingival index score and Sulcus Bleeding index score in both site A (Control) and site B (Test) at different time points, from baseline to 45th day and baseline to 60th day.

2.      On comparison between Site A and Site B on 45th day and 60th day there was no significant difference noted in Plaque index scores and Gingival Index Scores. However there was a significant different in Sulcus Bleeding Index scores on 60th day.

3.      There was a statistically significant reduction in Probing pocket depth and gain in Clinical attachment level in both Site A and Site B from baseline to 45th day and from baseline to 60th day. On comparison of probing pocket depth and clinical attachment on 45th day and 60th day between Site A and Site B showed no significant difference.

 

As evident from the present study it can be concluded that both Site A and Site B showed significant improvement in all the clinical parameters from baseline to 60th day, but adjunctive use of tetracycline fiber (Actisite) showed a significant improvement on Sulcus  Bleeding Index score alone.

 

Further long term studies are recommended to evaluate the adjunctive use of tetracycline fiber (Actisite) and also to compare it with other local drug delivery system.

 


 

 

 

1.Tables

Table 1(A) Comparison of Mean Plaque Index Scores and Percentage Changes within Sites, Site-A (Control) and Site-B (Test) at Different Time Points and Its Significance

TIME

SITE-A (CONTROL)

SITE-B (TEST)

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

0 DAY

2.3 ±0.49

--

--

--

2.17 ±0.50

--

--

--

45TH DAY

1.51 ±0.37

0.79 ±0.33

34.3%

9.32  P<0.001

1.35 ±0.34

0.82 ±0.36

37. 7%

8.80 P<0.001

60TH DAY

1.03 ±0.13

1.27 ±0.46

55.2%

10.72 P< 0.001

0.93 ±0.15

1.24 ±0.48

57.1%

10.02 P<0.001

* Students paired t-test

P< 0.001: Highly Significant


 


 

Table 1( B) Comparison of Mean Plaque Index Scores Between Site-A (Control) and Site-B (Test) and Its Significance

TIME

Plaque Index Scores Between Site-A (Control) and Site-B (Test)

Significance Between Site-A (Control) And Site-B (Test)

Site-A (Control)

Site-B (Test)

Mean ± SD

Mean ± SD

45TH DAY

0.79 ±  0.33

082 ± 0.36

0.79N.S.

60TH DAY

1.27 ± 0.46

1.2 ± 0.48

0.85N.S.

* Student independent t-test

NS :- Not Significant


Table2 (A) Comparison of Mean Gingival Index Scores and Percentage Changes within Sites, Site-A (Control) and Site-B (Test) at Different Time Points and Its Significance

TIME

SITE –A (CONTROL)

SITE –B (TEST)

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

0- DAY

1.88 ±0.67

--

--

--

1.83±0.61

--

--

--

45TH DAY

1.23 ±0.50

0.65± 0.23

34.5%

11.06  P 0.001

1.18 ± 0.45

0.65±0.26

35.5%

9.54 P < 0.001

60TH DAY

1.0 ± 0.19

0.88 ± 0.57

46.80%

6.05 P < 0.001

0.83 ±0.23

1.0± 0.57

54.64%

6.74 P < 0.001

* Significant Paired t-test

P < 0.001 : Highly Significant

 

Table 2(B) Comparison of Mean Gingival Index Scores Between Site-A (Control) and Site-B (Test) and Its Significance

TIME

Gingival Index Scores Between Site-A (Control) and Site-B (Test)

Significance Between Site-A (Control) And Site-B (Test)

Site-A (Control)

Site-B (Test)

Mean ± SD

Mean ± SD

45th Day

0.65 ± 0.23

0.65 ± 0.26

1N.S.

60th Day

0.88 ± 0.57

1.0 ± 0.57

0.5N.S.

* Student independent t-test

NS : Not significant

 

Table 3(A) Comparison of Sulcus Bleeding Index Scores and Percentage Changes Within Sites, Site-A (Control) and Site-B (Test) at Different Time Points and Its Significance

TIME

SITE-A (CONTROL)

SITE-B (TEST)

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

0 DAY

3.43±0.42

 

 

 

3.23±0.45

 

 

 

45TH DAY

2.30±0.30

1.13±0.30

32.9%

14.57P<0.001

2.0±0.37

1.23±0.32

38. 7%

14.7P<0.001

60TH DAY

1.8±0.24

1.63±0.44

47.5%

14.32P< 0.001

1.25±0.34

1.98±0.35

61.3%

21.7P<0.001

* Student paired t-test

P< 0.001 : Highly Significant.

 

Table 3(B) Comparison of Sulcus Bleeding Index Scores between Site-A (Control) and Site-B (Test) At Different Time Points and Its Significance

Time

Sulcus Bleeding Index Scores Between Site-A (Control) And Site-B (Test)

Significance Between Site-A (Control) And Site-B (Test)

 

Site-A (Control)

Site-B (Test)

Mean ± SD

Mean ± SD

45TH DAY

1.13 ±  0.30

1.23 ± 0.32

0.46N.S.

60TH DAY

1.63 ± 0.44

1.98 ± 0.35

2.61P < 0.01

*Students independent t-test

NS: Not Significant

P < 0. 001: Highly Significant.

 

 

Table 4(A) Comparison of Mean and Percentage Reduction in Pocket Depth within Sites, Site-A (Control) and Site-B (Test) at Different Time Points and Its Significance

TIME

SITE-A (CONTROL)

SITE-B (TEST)

Mean

±SD

Changes

from

Baseline

%

Change

Significance

P-value

Mean

±SD

Changes

From

Baseline

%

Change

Significance

P-value

0 DAY

6.4 ±1.06

--

--

--

6.26±0.70

--

--

--

45TH DAY

5.73±0.70

0.67±0.49

10.46%

5.29 P<0.001

5.58 ±0.56

0.68 ±0.52

10.8%

3.5 P<0.001

60TH DAY

4.8 ±0.77

1.6 ±0.51

25%

12.22 P< 0.001

4.6 ±0.74

1.66 ±0.49

26.5%

13.23 P<0.001

* Students paired t-test

P< 0.001: Highly Significant

 

 

 

Table 4 (B) Comparison of Reduction in Pocket Depth Between Site-A (Control) and Site-B (Test) and Its Significance

TIME

 

 

Gingival Index Scores Between Site-A (Control) And Site-B (Test)

Significance Between Site-A (Control) And Site-B (Test)

Site-A (Control)

Site-B (Test)

Mean ± SD

Mean ± SD

45th Day

0.67 ± 0.49

0.68 ± 0.52

0.28 N.S.

60th Day

1.6 ± 0.51

1.66 ± 0.49

0.72N.S.

* Student independent t-test  

NS : Not significant

 

Table 5 (A) Comparison of Mean and Percentage Reduction in Pocket Depth within Sites, Site-A (Control) and Site-B (Test) at Different Time Points and Its Significance

TIME

SITE-A (CONTROL)

SITE-B (TEST)

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

Mean

±SD

Changes

From Baseline

%

Change

Significance

P-value

0 DAY

7.53 ±1.35

--

--

--

7.33 ±1.23

--

--

--

45TH DAY

6.86 ±1.12

0.67 ±0.48

8.89%

5.29 P<0.001

6.64  ±1.23

0.69 ±0.62

9.41%

4.18 P<0.001

60TH DAY

5.86 ±1.12

1.67 ±0.48

22.17%

13.23

P< 0.001

5.64 ±1.17

1.69 ±0.62

23.05%

10.46 P<0.001

* Students paired t-test

P< 0.001: Highly Significant

 

T able 5 (B) Comparison of Gain in Clinical Attachment Level between Site-A (Control) and Site-B (Test) and Its Significance

TIME

 

Gingival Index Scores Between Site-A (Control) And Site-B (Test)

Significance Between Site-A (Control) And Site-B (Test)

Site-A (Control)

Site-B (Test)

Mean ± SD

Mean ± SD

45th Day

0.67 ± 0.48

0.69 ± 0.62

1N.S.

60th Day

1.67 ± 0.48

1.69 ± 0.62

1N.S.

* Students independent t-test

NS: Not significant


 



FIGURE 1

 

FIGURE 2

 

FIGURE 3

 

FIGURE 4

 

REFERENCES

1.       George MK, Cobb C.M. etal. Gingival response to subgingival placement of monolithic tetracycline- impregnated fibersMicroscopic Obdervation. Int.1 Peerio dent.Rest Dent. 1993; 13: 151-171.

2.       Moore WEC. Microbiology of Periodontal Disease; 1 Periodontal Reasearch 1987; 22: 335-341. 3. Clancio SG, Cobb C.M. etal. Tissue Concentration and Localization of Tetracycline following Site- Specific. Tetracycline Fiber Therapy. J.Periodontal 1992; 63: 849-853.

4.       Greenstien G and Polson A : The role of local drug delivery in the management of periodontal diseases. A Comprehensive Review: Journal of Periodontology 1998; 69: 507-520.

5.       Tetracycline Fiber Product; Literature on Actisite. Manufactured by Aiza Co-operation (Proter and Gamble), PALO ALTO, CA 94 303, U.S.A.

6.       Goodson J.M., Cugini M.A. etal. Multicenter evaluation of tetracycline fiber therapy II ; Clinical response, J PeriodentRest 1991; 26: 371-379.

7.       Tonetti M.S. Pini- Prato G.P. etal. Principles and clinical applications of periodontal cont4rolled drug delivery with tetracycline fibers. Int jk periodont Resdent 1994; 14: 421-435.

8.       Trombelli L, Scabbia a etal. Clinical effect of subgingival tetracyckline irrigation and tetracycline loaded fiber application in the treatement of adult periodontitis.Quintessence Int. 1996: 27: 19-25.

9.       Newman M.G., Kornman K.S etal. A 6 month multicenter evaluation of adjunctive tetracycline fiber therapy used in conjunction with scalling and Root planing in maintenance Patients; Clinical results. J Peruiodonatl 1994; 65: 685.

10.    Michalowicz B.S., Pihlstrom B.L etal. Evaluation of periodontal treatment using controlled – release tetracycline fibers: Maintenance response. J periodontal 1995; 66: 708-715.

11.    Kerry G., tetracycline- Loaded fibers as adjunctive treatment in periodontal disease. J A M dent. Association 1994; 125: 1199-1203.

12.    Drisko CL,Cobb CM, Killoy WJ,et al. Evaluation of periodontal treatments using controlled- release tetracycline fibres. Clinical response. J Periodontol 1995;66:692-699.

13.    Gary Greenstein. Local drug delivery in the treatment of periodontal diseases; Assessing the clinical significance of results. J Periodontol 2006;77:563-578.

 

 

 

 

Received on 21.11.2012       Modified on 11.12.2012

Accepted on 18.12.2012      © RJPT All right reserved

Research J. Pharm. and Tech. 6(1): Jan. 2013; Page 90-95