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
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 ...view middle of the document...
The investigator and the participants were unaware of the group allocation and the composition of the mouth rinse received by the respective groups. Once the study was completed, the manufacturing company did the decoding of the mouth rinses.
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.
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.
The investigator demonstrated to and trained the subjects regarding a proper method of mouth rinsing. Ten milliliters of mouth rinse from the respective bottles was measured using a graduated plastic jar and dispensed to the subjects. They were asked to perform mouth rinsing thoroughly once daily for 60s and spit out the solution. After this procedure, the children were instructed not to eat or drink anything for about thirty minutes. The above procedure was repeated on each school day during morning hours for a period of six months, starting October 2010. The subjects were instructed to report any adverse events such as sickness, change in taste perception, soreness of the tongue, edema, redness, sensitivity, burning sensation of the oral mucosa and visible staining during the course of the study, to the class teacher or investigator. Such a finding was duly recorded in the pro-forma. The investigator supervised the daily mouth rinsing activity performed by the subjects in three schools. The class teacher and the group leader were trained to carry out the activity in the absence of an investigator. This study was designed in such a way as to simulate the natural conditions; therefore, neither oral prophylaxis was performed nor were any oral hygiene instructions given.
Statistical analysis was done on an intention-to-treat basis, with missing data being...