Professional Documents
Culture Documents
Effectiveness of A Controlled Release Chlorhexidin
Effectiveness of A Controlled Release Chlorhexidin
35]
Original Article
Department of Abstract:
Periodontology and Aims and objectives: The aim of this study is to evaluate the effectiveness of a controlled‑release
Imlantology, Meenakshi chlorhexidine chip as an adjunctive therapy to scaling and root planing when compared with scaling and
Ammal Dental College, root planing alone in the treatment of chronic periodontitis. Materials and Methods: 20 patients with a total
Maduravoyal, Chennai, number of 40 posterior sites were selected. These sites were divided into two groups in a split mouth design,:
India Group A (control site) had 20 sites treated with scaling and root planing alone and Group B (test site) had
20 sites treated with scaling and root planing and PerioColTM-CG. The clinical parameters (Plaque index,
bleeding on probing, probing pocket depth, clinical attachment level) were recorded at baseline, 90th and
180th day for both the groups. Results: When both groups were compared the change in Plaque index was
significantly higher in Group B when compared to Group A on the 90th day and 180th day. However, there was
no statistically significant difference in the mean percentage of gingival bleeding sites between the two groups
Access this article online on the 90th day, though Group B showed a statistically higher reduction in the mean percentage of gingival
Website: bleeding sites at the end of 180th day. There was no statistically significant difference in probing pocket depth
www.jisponline.com between the two groups on both 90th and 180th day. Gain in clinical attachment level was significantly higher
DOI:
in Group B when compared to Group A on the 90th and 180th day. Conclusion: From the results observed
10.4103/0972-124X.106909 in this study, it can be concluded that the adjunctive use of PerioColTM‑CG was safe and provided significant
improvement in both Plaque index and gingival bleeding index. It was also more favorable than scaling and
Quick Response Code: root planing alone for gain in clinical attachment level.
Key words:
Chronic periodontitis, chlorhexidine, scaling and root planing, probing pocket depth and clinical attachment level
Journal of Indian Society of Periodontology - Vol 16, Issue 4, Oct-Dec 2012 553
[Downloaded free from http://www.jisponline.com on Thursday, June 14, 2018, IP: 188.146.161.35]
• sustained release devices was done with ultrasonic scalers and oral hygiene instructions
• controlled delivery devices were given. Impressions were taken and an acrylic stent was
made for standardized measurements of probing pocket depth
Sustained release formulations are designed to provide drug and clinical attachment level [Figure 1a, c-e].
delivery for less than 24 h. On the other hand, controlled
delivery systems should have duration of drug release that The clinical parameters (Plaque index, bleeding on probing,
exceeds 1 day.[2,3] probing pocket depth, clinical attachment level) were recorded
at baseline, 90th, and 180th day.
Chlorhexidine has long been used as an effective antimicrobial
agent. Its mechanism of action relates to reduction in pellicle Baseline (0 day): After recording the clinical parameters, scaling
formation, alteration of bacterial adherence to teeth and an and root planing was performed using ultrasonic scalers
alteration of bacterial cell wall causing lysis. Chlorhexidine is and Gracey curettes in control sites [Figure 2] and test sites
effective against subgingival plaque bacteria when delivered [Figure 3a]. It was followed by the placement of PerioColTM‑CG
via a sustained‑release device for 9 days. The antimicrobial at the (test sites) Group‑B [Figure 3b].
effects were evident up to 11 weeks after treatment, and clinical
efficacy in terms of reduced probing depth, clinical attachment Placement of Periocol‑CG: After scaling and root planing, the
levels, and reduction of bleeding on probing was evident. test sites were dried with cotton pellets. The PerioColTM‑CG
A biodegradable chip for sustained and direct delivery of was taken with a sharp tweezer tip from an individual foil
chlorhexidine to the periodontal pocket has been developed.[4] packet. PerioColTM‑CG was moistened with normal saline.
It was grasped at the flat end, and the curved end was first
The aim of this study is to evaluate the effectiveness of a inserted into the periodontal pocket. It was gently pressed
controlled‑release chlorhexidine chip (PerioColTM‑CG) as an apically to the base of the pocket without any folds [Figure 3b].
adjunct to scaling and root planing when compared with After placement into the test sites, patients were instructed
scaling and root planing alone in the treatment of chronic not to use interdental cleansers such as dental floss or tooth
periodontitis. pick for the next 10 days to avoid displacement, or any kind of
chemotherapeutic mouth rinses or oral irrigation device. The
PerioColTM-CG is manufactured by Eucare pharmaceuticals patients were recalled on the third and seventh day to assess
(P) Ltd. PerioColTM‑CG is a small, orange‑ brown rectangular the position of PerioColTM‑CG.
chip. It is rounded at one end for easy insertion into periodontal
pockets. Each PerioColTM‑CG contains approximately 2.5 mg of On 90th day: The clinical parameters were recorded in both
chlorhexidine gluconate in a biodegradeable matrix of Type 1 Groups A and B [Figures 2 and 3a]. Supragingival scaling was
collagen derived from fish sources. PerioColTM‑CG releases performed in both Groups A and B. PerioCol‑CGTM was again
chlorhexidine in vitro with a release profile of approximately placed into Group B.
40‑45% within 24h and afterward in linear fashion for 7‑8 days.
The release profile may be explained by initial burst effect due On 180th day: The clinical parameters were recorded in both
to diffusion of the drug from the chip followed by release of Groups A and B.
the drug due to enzymatic degradation.
Statistical analysis
MATERIALS AND METHODS The mean and standard deviation were compared by using
Student’s paired t‑test, Wilcoxon’s signed rank test, and
Twenty patients, aged 35‑55 years, diagnosed with generalized McNemar’s test.
chronic periodontitis, having probing pocket depth ≥5mm
were selected from the Department of Periodontology and RESULTS
Implantology, Meenakshi Ammal Dental College, Chennai, for
this study which was approved by Ethical Committee. Overall, 40 sites were treated, 20 with SRP and 20 with SRP
plus CHX chip.
A total number of 40 posterior sites were selected. These sites
were divided into two groups in a split mouth design. Table 1 shows the comparison of mean, standard deviation, and
test of significance for the Plaque index score between Groups
Group‑A (control site) had 20 sites treated with scaling and A and B at different time points.
root planing alone.
At baseline, there was no statistically significant difference in
Group‑B (test site) had 20 sites treated with scaling and root the Plaque index score between the SRP alone and the CHX plus
planing and PerioColTM‑CG.
Table 1: Comparison of mean, standard deviation, and
Exclusion criteria included allergy to chlorhexidine, presence of
test of significance for the Plaque index score between
overhanging restoration, smoking, pregnant women, those who
Groups A and B at different time points
have received antibiotics or any form of periodontal treatment
in the previous 6 months. Treatment Baseline 90th day 180th day
Group A 1.5(0.3) 1.1(0.3) 0.9(0.3)
Study design Group B 1.5(0.3) 0.9(0.3) 0.7(0.2)
P value 0.32 0.001 <0.0001
After selection of patients, a full mouth supragingival scaling
554 Journal of Indian Society of Periodontology - Vol 16, Issue 4, Oct-Dec 2012
[Downloaded free from http://www.jisponline.com on Thursday, June 14, 2018, IP: 188.146.161.35]
a b
c d e
Figure 1: (a) Armamentarium; (b) PerioCol-CG; (c) Chronic periodontitis; (d) Assessment of bleeding on probing; (e) After scaling and root planing
a
Figure 2: Group A - Measurement of probing pocket depth and clinical attachment
level using acrylic stent
Journal of Indian Society of Periodontology - Vol 16, Issue 4, Oct-Dec 2012 555
[Downloaded free from http://www.jisponline.com on Thursday, June 14, 2018, IP: 188.146.161.35]
SRP plus CHX chip group compared to baseline. At 180th day Table 2: Percentage of gingival bleeding sites in Group
PD was further reduced to 4.8mm in SRP alone group and A and B at different time points
4.2 mm in the SRP plus CHX chip group, respectively. Time point Gingival Group A Group B P value
bleeding index (n=20) (n=20)
Table 4 shows the comparison of mean change in probing No. % No. %
pocket depth between Group A and B from baseline. Mean Day 0 + 20 100 20 100 −
reduction in probing pocket depth between 0 and 90th day in − 0 0 0 0
Group A was 1.4±0.5 mm and in Group B it was found to be Day 90 + 15 75 11 55 0.12(NS)
1.6±0.5 mm. Mean reduction in probing pocket depth between − 5 25 9 45
180th day in Group A was 2.8±1.0 mm and in Group B it was Day 180 + 12 60 3 15 0.004(Sig.)
found to be 3.2±0.6 mm. − 8 40 17 85
+ : Presence / postivity for bleeding; − : Absence / negativity for bleeding
Table 5 shows the comparison of mean change in clinical
attachment level between Group A and B from baseline. The Table 3: Comparison of mean, standard deviation, and
mean gain in clinical attachment level from Day 0 to 90 in test of significance for probing pocket depth between
Group A was 1.3±0.5 mm and in Group B it was 1.8±0.6 mm. Group A and B at different time points
The mean gain in clinical attachement level from Day 0 to 180 Treatment Baseline 90th day 180th day
in Group A was 2.7±1.0 mm and in Group B it was 3.2±0.9 mm.
Group A 7.6 mm (1.0) 6.2 mm (1.2) 4.8 mm (1.4)
Group B showed a significant gain in the clinical attachment Group B 7.4 mm (1.0) 5.8 mm (1.1) 4.2 mm (1.3)
level as compared to Group A from baseline to 90th day and P value 0.27 0.03 0.04
180th day, respectively.
556 Journal of Indian Society of Periodontology - Vol 16, Issue 4, Oct-Dec 2012
[Downloaded free from http://www.jisponline.com on Thursday, June 14, 2018, IP: 188.146.161.35]
scaling while the control group received supragingival scaling treatment of periodontitis. Clinical results. J Clin Periodontol
only. 1998;25:953‑8.
5. Soskolne WA, Heasman PA, Stabholz A. Sustained local delivery
The mean gain in the clinical attachment level from baseline to of chlorhexidine in the treatment of periodontitis: A multi‑center
study. J Periodontol 1997;68:32‑8.
90th day, and baseline to 180th day was statistically significant in
Group A and Group B. On comparing the mean gain in clinical 6. Jeffcoat MK, Kimberly S. Bray, Sebastian G. Ciancio. Adjunctive
Use of a Subgingival Controlled‑Release Chlorhexidine Chip
attachment level between Group A and B, the gain was higher Reduces Probing Depth and Improves Attachment Level
in Group B. In Group A, the improvement in clinical attachment Compared With Scaling and Root Planing Alone. J Periodontol
level was due to deeper baseline probing depth in the present 1998;69:989‑97.
study. According to Kaldahl,[18] there was greater gain in clinical 7. McNaabb H, Monbelli A and LangNP. Supragingival cleaning
attachment level after scaling and root planing with PPD of 3 times a week. The microbial effects in moderately deep pockets.
>4 mm. In Group B, the sites were treated by SRP followed by J Clin Periodontol 1992;19:348‑56.
treatment of periodontal pockets with PerioColTM‑CG. With 8. Dahlen G, Lindhe J, Sato K, Hanamura Y. The effects of
the additional placement of chlorhexidine chip, there was supragingival plaque control on the subgingival microbiota in
sustained exposure of chlorhexidine in pocket environment subjects with periodontal disease. J Clin Periodontol 1992;19:802‑9.
for 6‑9 days which gave long‑lasting effects on microbiota. 9. Ximmenez‑ Fyvie LA, Haffajee A, Thompson M. The effect
This would have brought about additional gain in the clinical of repeated professional supragingival plaque removal on
the composition of supra and subgingival microbiota. J Clin
attachment level in Group B. These findings were similar to
Periodontol 2000;27:637‑47.
studies by Soskolne[14] and Jeffcoat[15] who also demonstrated
10. Mizrak T, Güncü GN, Caglayan F, Balci TA, Aktar GS. Effect
gain in the clinical attachment level in test sites which received of a controlled‑release chlorhexidine chip on clinical and
the chlorhexidine chip. microbiological parameters and prostaglandin E2 levels in
gingival crevicular fluid. J Periodontol 2006;77:437‑43.
Studies done by Mizrak[10] and Azmak[16] demonstrated that 11. Hill RW, Ramfjord SP. Morrinson EC. Four types of periodontal
after placement of Periochip there was reduction in GCF PGE2 treatment compared over two years. J Periodontol 1981;52:655‑62.
and GCF MMP‑8 levels. In this present study, the adjunctive use 12. Philstorm BL, Mc Hugh RB, Oliphant TH. Comparision of surgical
of chlorhexidine along with SRP resulted in a beneficial effect and non surgical treatment of periodontal disease. A review of
in both clinical and microbiological parameters which could current studies and additional results after six and one half year.
have been due to reduction in GCF PGE2 levels and reduction J Clin Periodontol 1983;10:524‑41.
in GCF MMP‑8 levels. The microbiological analysis and GCF 13. Cugini MA, Haffajee A D, Smith C, Kent Jr RL, Socransky S.
analysis after placement of the chlorhexidine chip was not The effects of scaling and root planing on the clinical and
microbiological parameters of periodontal diseases: 12 month
performed as it was not within the scope of this study.
results. J Clin Periodontol 2000;27:30‑6.
14. Soskolne WA, Stabholz A. An in vivo study of the periochip in
However, long‑term studies are required with larger sample the gingival crevicular fluid, plasma and urine. J Clin Periodontol
size and longer time period with microbiological analysis to 1998;25:1017‑21.
evaluate the effectiveness of PerioColTM‑CG. 15. Jeffcoat MK, Palcanis KG, Weatherford TW, Reese M, Geurs
NC, Flashner M. Use of a biodegradable chlorhexidine chip in
CONCLUSION the treatment of adult periodontitis: clinical and radiographic
findings. J Periodontol 2000;71:256‑62.
From the results observed in this study, it can be concluded 16. Azmak N, Atilla G, Luoto H, Sorsa T. The effect of subgingival
that the adjunctive use of PerioColTM‑CG was safe and provided controlled‑release delivery of chlorhexidine chip on clinical
parameters and matrix metalloproteinase‑8 levels in gingival
significant improvement in the Plaque index and gingival
crevicular fluid. J Periodontol 2002;73:608‑15.
bleeding index. It was more favorable than scaling and root
17. Paolantonio M, D’Angelo M, Grassi RF. Clinical and microbiologic
planing alone in the reduction of probing pocket depth and effects of subgingival controlled‑release delivery of chlorhexidine
gain in the clinical attachment level. chip in the treatment of periodontitis: A multicenter study.
J Periodontol 2008;79:271‑82.
REFERENCES 18. Kaldahl WB, Kenneth LK, Patil KD. Evaluation of four modalities
of Periodontal therapy. J Periodontol 1988;59;783‑93.
1. Cetin EO, Buduneli N. In vitro studies on controlled‑ release
cellulose acetate films for local drug delivery of chlorhexidine,
How to cite this article: Kondreddy K, Ambalavanan N,
indomethacin and meloxicam. J Clin Periodontol 2004;31:
Ramakrishna T, Kumar RS. Effectiveness of a controlled release
1117‑21.
chlorhexidine chip (PerioColTM‑CG) as an adjunctive to scaling and
2. Langer R, Peppas N. Present and future applications of root planing when compared to scaling and root planing alone in
biomaterials in controlled drug delivery systems. Biomaterials the treatment of chronic periodontitis: A comparative study. J Indian
1981;2:201‑4. Soc Periodontol 2012;16:553-7.
3. Langer R. New methods of drug delivery. Science 1990;249:1527‑33.
Source of Support: Nil, Conflict of Interest: None declared.
4. Killoy WJ. The use of locally delivered chlorhexidine in the
Journal of Indian Society of Periodontology - Vol 16, Issue 4, Oct-Dec 2012 557