Efficacy of Three Mouth Rinses in Reducing Dental Plaque and Gingivitis

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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…show more content…
Calibration
The investigator was self-trained and calibrated before the study and during the course of study. Data recording was done by a recorder who had been trained and calibrated prior to the main study. To evaluate the intra-examiner reliability, duplicate examinations were conducted at baseline, after three months and at the end of the study. The related kappa values were 0.84, 0.92 and 0.94, respectively.
Study outcomes
The oral examinations were performed at baseline, 3 months and 6 months. At the baseline examination, personal information of the subjects was recorded in a specially prepared pro-forma. The children were examined on a chair by the investigator under natural light using mouth mirror and explorer/probe. Reducion in PlI score was considered as the primary outcome and difference in GI scores between four groups was the secondary outcome. At each intraoral examination, presence of plaque and gingivitis was determined using the criteria suggested by Loe H.17 PlI and GI scores were recorded on all surfaces (mesial, distal, buccal, palatal/lingual) of all the teeth. The scores from the four areas of the tooth were added and divided by four to give the PlI/GI for the tooth. PlI and GI for the individual is obtained by adding the indices for the teeth and dividing by the number of teeth examined.
Procedure:
The investigator demonstrated to and trained the subjects regarding a proper method of
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