PeriodontitisNCT06980714
Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis
A study testing Powered and Manual in people with Periodontitis and Dental Plaque, run by University of L'Aquila at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Plaque, Gingival Bleeding
- What is being tested?
- Powered and Manual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis
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.
Read the 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.
- Conditions
- Periodontitis, Dental Plaque, Gingival Bleeding
- Being tested
- Powered, Manual
- Keywords
- Periodontitis, Full-Mouth Plaque Score, Full-Mouth Bleeding Score, Home Oral Hygiene
- Medical subject headings
- Periodontitis, Dental Plaque, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoweredBehavioural
The intervention involves the use of the Oral-B iO6 powered toothbrush, which provides oscillating-rotating brushing action with personalized feedback via its smart pressure sensor and app integration. Participants in this group are instructed to brush for at least two minutes twice daily. The toothbrush is designed to ensure consistent brushing performance, with real-time feedback on brushing technique and duration, allowing for improved oral hygiene habits. The intervention aims to standardize brushing duration and technique, eliminating potential variations found with manual brushing.
ManualBehavioural
The intervention involves the use of the TePe Select Soft manual toothbrush, which features soft bristles for gentle yet effective plaque removal. Participants in this group are instructed to brush for at least two minutes twice daily, with guidance on proper brushing technique. To ensure compliance with the brushing duration, participants are required to use a smartphone app that tracks and records their brushing sessions. The manual toothbrush allows for participant control over brushing pressure and technique, with no additional oral hygiene aids allowed during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Manual | Active comparator | Participants assigned to this arm use a manual toothbrush (TePe Select Soft) to perform twice-daily toothbrushing for at least 2 minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. Brushing sessions are monitored and recorded via a smartphone app to ensure compliance with the 2-minute minimum duration. Receives: Behavioral: Manual |
| Powered | Experimental | Participants assigned to this arm use a powered toothbrush (Oral-B iO6) to perform twice-daily toothbrushing for at least two minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. The powered toothbrush provides consistent brushing performance, and participants are monitored to ensure compliance with the 2-minute minimum duration. Receives: Behavioral: Powered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-Mouth Bleeding Score (FMBS)
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.
Measured: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.
Secondary outcomes (1)
Systolic and Diastolic Blood Pressure (SBP and DBP)
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.
Measured: SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Pietropaoli, University of L'Aquila
- Investigators
- Davide Pietropaoli, DDS, PhD, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980714
- Sponsor's protocol ID
- Verb n. 25 del 14/09/22 Addend
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, individual participant data (IPD) will be shared with qualified researchers upon request, following ethical guidelines and the necessary approvals. The data will be anonymized and shared through a secure data repository to ensure privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis
- ClinicalTrials.gov ID
- NCT06980714
- Acronym / sponsor ID
- Verb n. 25 del 14/09/22 Addend
- Conditions
- Periodontitis, Dental Plaque, Gingival Bleeding
- Keywords
- Periodontitis, Full-Mouth Plaque Score, Full-Mouth Bleeding Score, Home Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Manual | Active comparator | Behavioral: ManualParticipants assigned to this arm use a manual toothbrush (TePe Select Soft) to perform twice-daily toothbrushing for at least 2 minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. Brushing sessions are monitored and recorded via a smartphone app to ensure compliance with the 2-minute minimum duration. |
| Powered | Experimental | Behavioral: PoweredParticipants assigned to this arm use a powered toothbrush (Oral-B iO6) to perform twice-daily toothbrushing for at least two minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. The powered toothbrush provides consistent brushing performance, and participants are monitored to ensure compliance with the 2-minute minimum duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PoweredThe intervention involves the use of the Oral-B iO6 powered toothbrush, which provides oscillating-rotating brushing action with personalized feedback via its smart pressure sensor and app integration. Participants in this group are instructed to brush for at least two minutes twice daily. The toothbrush is designed to ensure consistent brushing performance, with real-time feedback on brushing technique and duration, allowing for improved oral hygiene habits. The intervention aims to standardize brushing duration and technique, eliminating potential variations found with manual brushing. | Behavioural | Powered |
| ManualThe intervention involves the use of the TePe Select Soft manual toothbrush, which features soft bristles for gentle yet effective plaque removal. Participants in this group are instructed to brush for at least two minutes twice daily, with guidance on proper brushing technique. To ensure compliance with the brushing duration, participants are required to use a smartphone app that tracks and records their brushing sessions. The manual toothbrush allows for participant control over brushing pressure and technique, with no additional oral hygiene aids allowed during the study period. | Behavioural | Manual |
Primary outcome
Full-Mouth Bleeding Score (FMBS)
Time frame: 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.
1 secondary outcome
Systolic and Diastolic Blood Pressure (SBP and DBP)
Time frame: SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. Yes, individual participant data (IPD) will be shared with qualified researchers upon request, following ethical guidelines and the necessary approvals. The data will be anonymized and shared through a secure data repository to ensure privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Pietropaoli, DDS, PhD principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered and Manual in people with Periodontitis and Dental Plaque, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full-Mouth Bleeding Score (FMBS) (time frame: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.