Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis
- Conditions
- PeriodontitisDental PlaqueGingival Bleeding
- Registration Number
- NCT06980714
- Lead Sponsor
- University of L'Aquila
- Brief Summary
This study compares the effectiveness of powered and manual toothbrushes in reducing gum bleeding and dental plaque in people with stage 3 or 4 periodontitis. All participants are trained to brush for at least two minutes twice a day. The goal is to find out whether using a powered toothbrush leads to better oral hygiene results than a manual one, when brushing time is standardized. The study will measure bleeding and plaque levels at the beginning and over a 6-month period.
- Detailed Description
This single-blind, randomized controlled trial evaluates the clinical effectiveness of powered versus manual toothbrushing in patients newly diagnosed with stage 3 or 4 periodontitis. Participants are randomly assigned to one of two groups: powered toothbrush (Oral-B iO6) or manual toothbrush (TePe Select Soft). All participants receive standardized oral hygiene instructions and are instructed to brush twice daily for a minimum of two minutes. Manual brush users are required to use a smartphone app to monitor and record brushing duration. The use of adjunctive oral hygiene aids, such as mouthwash or interdental cleaners, is restricted throughout the study period. The primary clinical outcomes are full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS), measured at baseline and at follow-ups of 7 days, 1 month, 3 months, and 6 months.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Adults aged 18 to 75 years
- Diagnosis of stage 3 or 4 periodontitis based on clinical and radiographic examination
- Retaining at least 16 natural teeth
- Ability to follow oral hygiene instructions and compliance with the study protocol
- Willingness to refrain from using additional oral hygiene products (e.g., mouthwash, interdental cleaners) during the study
- Ability to provide informed consent
- Presence of systemic conditions that may affect oral health (e.g., uncontrolled diabetes, immunocompromised states)
- Pregnancy or breastfeeding
- Ongoing use of antibiotics or other medications that could interfere with gum health
- Severe dental conditions (e.g., tooth mobility > 2, advanced root resorption)
- Prior use of a powered toothbrush within the last 6 months
- Participation in another clinical trial that could interfere with study outcomes
- Inability or unwillingness to comply with study requirements or provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Full-Mouth Bleeding Score (FMBS) FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention. The Full-Mouth Bleeding Score (FMBS) will be used to assess the level of gingival bleeding upon gentle probing across all teeth in the mouth. This measure will evaluate the overall gum health of participants and will help compare the effectiveness of the powered versus manual toothbrushes in reducing gingival inflammation. FMBS will be recorded at baseline, 7 days, 1 month, 3 months, and 6 months to monitor changes in bleeding over time.
- Secondary Outcome Measures
Name Time Method Systolic and Diastolic Blood Pressure (SBP and DBP) SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months. Systolic and Diastolic Blood Pressure (SBP and DBP) will be measured using the Omron M6 device, following the European Society of Hypertension (ESH) guidelines for proper measurement techniques. Blood pressure will be recorded to evaluate any potential changes related to the oral hygiene interventions. Measurements will be taken at baseline, 1 month, 3 months, and 6 months to monitor any trends in blood pressure variation over the course of the study.
Trial Locations
- Locations (1)
University of L'Aquila
🇮🇹L'Aquila, Italy