A clinical study to assess the efficacy of an electric toothbrush to reduce dental plaque and gum inflammation in persons who have braces to align teeth

INTERVENTION: Participants are stratified at baseline on mean gingivitis score, number of bleeding sites, mean pre‐brushing plaque index and age. Within these strata, participants are randomly assigned to either the Test group (electric toothbrush) or the Control group (regular manual toothbrush). The randomization will be done using a computer‐based program which is provided by the sponsor. Participants are instructed to use the study products according to the manufacturer's instructions (electrical toothbrush) or in their customary manner (manual toothbrush) at home twice daily (morning and evening) in place of their normal oral hygiene for the duration of the study (12 weeks). Both products will be used with a regular marketed dentifrice. Plaque measurements will be taken at: Baseline visit (pre‐ and post‐brushing), Week 6, and Week 12 visits (both pre‐brushing only). Gingivitis measurements will be taken at: Baseline, Week 6, and Week 12 visits. CONDITION: Evidence of dental plaque and gingivitis in an orthodontic population ; Oral Health PRIMARY OUTCOME: ; 1. Dental plaque (pre‐brushing) measured by Turesky Modified Quigley Hein Plaque Index at; baseline, week 6 and week 12.; 2. Gingival inflammation measured by Modified Gingival Index at baseline, week 6 and week 12.; SECONDARY OUTCOME: There are no secondary outcome measures. INCLUSION CRITERIA: 1. Give written informed consent (including her/his guardians in case of being adolescent) and be given a signed copy of the Informed Consent form 2. Have fixed orthodontic appliances in both dental arches 3. Be at least 13 years old and typically use a manual toothbrush 4. Possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces 5. Have a whole mouth average Baseline TQHPI score of 1.75 6. Have a Baseline whole mouth mean LSGI score of at least 1.75 but not more than 2.5 7. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history 8. Agree not to participate in any other oral care study for the duration of this study 9. Agree to return for scheduled visits and follow the study procedures<