A randomized clinical study to compare the efficacy of a new interactive toothbrush in the prevention of dental stain

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Participants are stratified at baseline on average modified Lobene composite score of the facial and lingual surfaces, smoking, the consumption of coffee/tea and age. Within these strata, participants are randomly assigned to either the test group (new interactive toothbrush with whitening brush head) or the control group (marketed regular manual toothbrush). Participants are instructed to use the study products according to the manufacturer instructions (electric 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). Dental stain measurements are taken at baseline, week 4, and week 12 visits. CONDITION: Dental stain on facial surfaces of the anterior teeth ; Oral Health PRIMARY OUTCOME: ; 1. Intensity and extent of extrinsic dental stain on the facial and lingual surfaces of the anterior teeth is measured using Composite Modified Lobene Stain Index at Week 4 and Week 12; 2. Intensity and extent of extrinsic dental stain in four different regions (gingival, body, mesial and distal) on the facial surfaces of the anterior teeth is measured using Interproximal Modified Lobene Index at Weeks 4 and 12; SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Be at least 18 years of age and typically use a manual toothbrush 2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form 3. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history 4. Have a minimum of 10 anterior teeth suitable for grading (i.e., no crowns, bridge abutments, composites or porcelain veneers, large composite restorations or anterior calculus) with visible surface stain on the facial surfaces 5. Agree not to participate in any other oral care study for the duration of this study 6. Agree to return for scheduled visits and follow the study procedures 7. Agree to refrain from the use of any non‐study oral hygiene products (including prescription rinses) for the duration of the study
Epistemonikos ID: 1ceaea4e8d915a6e205f60f5765a15a98ae0aa9d
First added on: Aug 25, 2024