A randomized, placebo-controlled, double-blinded, parallel-group study was conducted for six months among 12 to 15 year olds school children in Nellore, India. The inclusion criteria were : 1) children with permanent dentition; 2) baseline plaque index (PlI) and gingival index (GI) scores of 2-3; 3) good general health; and 4) an ability to use a mouth rinse
Ethical Aspects
The study was performed in accordance with the guidelines of Good Clinical Practice and the Declaration of Helsinki as revised in 2000. The institutional review board (IRB) and ethical committee of the Narayana Dental College and Hospital gave approval for the study (IEC/NDC/1091/NDC/04.01.2010). The investigator provided detailed information about the study procedure, the benefits and the possible side-effects associated with the trial to the parents and written consent was obtained.
Sample size
A pilot study was conducted on fifty subjects before the main study to standardize the methods. The required sample size with a power of 80% and α error of 0.05% was estimated based on the pilot study data. Results of pilot study indicated that a total of 240 subjects were required. 240 children were assessed for eligibility. 210 eligible subjects from whose parent’s written consent was obtained were allowed to participate. The 50 participants of pilot study were included into main study.
Randomization and Blinding:
Manufacturing company M/S Group Pharmaceuticals was requested to provide the required quantity of mouth rinses in a pre-coded consignment. The company has provided mouth rinses in identical bottles, with same colour solution and in coded form. The children were drawn from three randomly selected schools of Nellore city. The eligible children from each...
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..., Afflitto J, Coleman EJ. The effect of triclosan on mediators of gingival inflammation. J Clin Periodontol 1995;22(6):480-484.
20. WHO. Oral Health Surveys, Basic Methods. 4th ed. 1997. p.7.
21. Lang NP, Hotz P, Graf H, Geering AH, Saxer UP, Sturzenberger OP, Meckel AH. Effects of supervised chlorhexidine mouth rinses in children. A longitudinal clinical trial. J Periodontal Res 1982;17(1):101-111.
22. Jenkins S, Addy M, Newcombe RJ. A dose-response study of triclosan mouthrinses on plaque regrowth. J Clin Periodontal 1993 Sep; 20(8):609-612.
23. Niklaus P, Lang, Brecx MC. Chlorhexidine digluconate- an agent for chemical plaque control and prevention of gingival inflammation. J Periodontal Res 1986; 21(Suppl. s16):74-89.
24. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.