Clinical trial NCT06980714: Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis
Official title: Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontitis
Dental Plaque
Gingival Bleeding
Keywords: Periodontitis
Full-Mouth Plaque Score
Full-Mouth Bleeding Score
Home Oral Hygiene
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned in a 1:1 ratio to either a powered toothbrush group or a manual toothbrush group. Each group follows the same oral hygiene protocol, with standardized brushing instructions. The two groups are followed in parallel over a 6-month period without crossover.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Full-Mouth Bleeding Score (FMBS)
timeFrame: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure (SBP and DBP)
timeFrame: SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
Study officials:
affiliation: University of L'Aquila
name: Davide Pietropaoli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: