Dental Plaque AccumulationNCT07030088
Evaluation of a Novel Dual-Headed Toothbrush Design for Periodontal Health: Split-Mouth Randomized Blind Clinical Trial
A study testing Dual-Headed Manual Toothbrush and Conventional Single-Headed Manual Toothbrush in people with Dental Plaque Accumulation and Oral Hygiene Education Methods, run by Dar Al Uloom University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and patient satisfaction of a novel dual-headed toothbrush design compared to a conventional single-headed toothbrush in adult dental professionals aged 22-45 years with healthy gingival conditions. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Dental Plaque Accumulation, Oral Hygiene Education Methods, Toothbrushing
- What is being tested?
- Dual-Headed Manual Toothbrush and Conventional Single-Headed Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2025to Dec 2025
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Dentists with a minimum of 26 natural teeth, good general health, and the ability to perform routine oral hygiene independently.
- No systemic diseases affecting oral hygiene.
- Record of mild-to-moderate plaque accumulation; PI score ≥ 1
- Rt handed dentists
Who cannot join
- • Participants with active periodontal disease, orthodontic appliances, or having recent oral surgery
- Those currently enrolled in any other dental trial
- Smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SREIC Scientific Research Ethics and Innovative committee contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
College of Dentistry, Dar AlUloom University
Riyadh, 11512
Sally ElHaddad, 00966555361062, s.elhaddad@dau.edu.sa
About this study
Official title: Clinical and Patient-Based Evaluation of a Novel Dual-Headed Toothbrush Design: Split-Mouth Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness and patient satisfaction of a novel dual-headed toothbrush design compared to a conventional single-headed toothbrush in adult dental professionals aged 22-45 years with healthy gingival conditions. The main questions it aims to answer are:
Does the dual-headed toothbrush improve plaque removal efficiency compared to a single-headed toothbrush? Does the dual-headed toothbrush enhance brushing comfort, reduce brushing time, and improve user satisfaction? Researchers will compare the side of the mouth (cleaned with a dual-headed toothbrush) with the other side (cleaned with a single-headed toothbrush) in a randomized split-mouth design to see if the novel design leads to superior plaque control and better user experience.
Read more
Participants will:
Receive both toothbrush types (medium bristle) and identical toothpaste Be trained in the Bass brushing technique Use each toothbrush, twice daily, with the assigned toothbrush applied to its designated side of the mouth
Complete post-trial questionnaires on comfort, ease of use, and brushing time
Read the detailed description
This clinical trial explores the comparative effectiveness and user experience of a novel dual-headed toothbrush design versus a conventional single-headed toothbrush using a randomized split-mouth methodology among adult dental professionals. Dental professionals were selected as participants due to their consistent oral hygiene habits and ability to comply with standardized brushing protocols.
The study investigates whether the dual-headed design can offer improved plaque removal efficiency, reduced brushing time, and greater comfort during use-factors that are increasingly relevant to both clinical performance and patient compliance in oral hygiene tools. Participants were trained to use both toothbrushes following the Bass technique and instructed to brush twice daily, with the left and right sides of the mouth assigned to different brushes.
The trial design allows for within-subject comparison, minimizing confounding variables such as brushing technique, motivation, and dietary habits. In addition to clinical measurements, participants' subjective experiences were captured through structured questionnaires focusing on comfort, ease of maneuverability, and time spent brushing.
This investigation aims to provide evidence to guide the development of more ergonomic and time-efficient toothbrush designs that improve plaque control without compromising user comfort. Findings from this study may influence the recommendation of dental hygiene tools, particularly for individuals seeking more efficient oral hygiene practices or patients with limited dexterity or who rely on caregivers.
- Being tested
- Dual-Headed Manual Toothbrush, Conventional Single-Headed Manual Toothbrush
- Keywords
- Dual-headed toothbrush, Single-headed toothbrush, Toothbrushing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Headed Manual ToothbrushDevice
A novel toothbrush with a dual-headed design intended to clean both upper and lower buccal/ or upper and lower lingual/ palatal surfaces simultaneously. Participants were instructed to use this toothbrush on one side of the mouth only, twice daily using the Bass brushing technique. This intervention is evaluated for plaque removal efficacy, gingival health, brushing time, and patient comfort
Conventional Single-Headed Manual ToothbrushDevice
A standard single-headed manual toothbrush used as the active control. Participants used this toothbrush on the other side of the mouth, with the same brushing technique (Bass method), frequency (twice daily). It serves as the comparator for assessing the performance of the dual-headed design.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Headed Toothbrush | Experimental | Participants used a dual-headed manual toothbrush to clean one side of their mouth (maxillary and mandibular quadrants). Brushing was performed using the Bass technique, twice daily. This arm assesses the effectiveness, comfort, and time-efficiency of the novel dual-headed toothbrush design. Receives: Device: Dual-Headed Manual Toothbrush |
| Single-Headed Toothbrush | Active comparator | Participants used a conventional single-headed manual toothbrush to clean the other side of their mouth using the same brushing technique (Bass method), frequency (twice daily). This arm serves as the standard control for comparison in evaluating plaque removal and patient-reported comfort. Receives: Device: Conventional Single-Headed Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI)
Difference in plaque scores between baseline and end of study on the left and right sides of the mouth, using the Silness and Löe Plaque Index.
Scale:
0 = No plaque, 1 = A film of plaque, 2 = Moderate plaque, 3 = Abundant plaque Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
Measured: After 2, and 4 weeks of brushing
Gingival Index (GI)
Löe \& Silness for GI Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing.
Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing.
Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.
Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
Measured: after 2 and 4 weeks
mSBI (modified sulcular bleeding index)
mSBI (modified sulcular bleeding index): 0: no bleeding when a periodontal probe is passed along the gingival margin
- isolated bleeding spots visible
- Blood forms a confluent red line on margin
- Heavy or profuse bleeding
Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
Measured: after 2, and 4 weeks
Secondary outcomes (2)
Brushing Time Per Side
Measure: Average time (in seconds) participants took to brush each side (left and right) during the trial.
Interpretation: Shorter brushing time with equal or better plaque control is considered a favorable outcome.
Measured: Self-reported after 4 weeks
Patient satisfaction and comfort
Patient satisfaction and comfort (evaluated using a Likert scale questionnaire):
5- point Likert scale: How easy or difficult is it to use the novel toothbrush?
Very difficult, Somewhat difficult , Neither difficult nor easy , Somewhat easy , Very easy
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque AccumulationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030088
- Sponsor's protocol ID
- 34-01-2025
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following de-identified individual participant data (IPD) will be made available for research purposes: Demographic data: Age, gender, and handedness (for brushing consistency) Plaque Index scores: Baseline and post-intervention scores for both left and right sides Brushing time data: Self-reported average brushing time per side Toothbrush preference: Participant-reported final preference (dual-headed vs. single-headed)
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient-Based Evaluation of a Novel Dual-Headed Toothbrush Design: Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07030088
- Acronym / sponsor ID
- 34-01-2025
- Keywords
- Dual-headed toothbrush, Single-headed toothbrush, Toothbrushing technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jun 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.
The goal of this clinical trial is to evaluate the effectiveness and patient satisfaction of a novel dual-headed toothbrush design compared to a conventional single-headed toothbrush in adult dental professionals aged 22-45 years with healthy gingival conditions. The main questions it aims to answer are:
Does the dual-headed toothbrush improve plaque removal efficiency compared to a single-headed toothbrush? Does the dual-headed toothbrush enhance brushing comfort, reduce brushing time, and improve user satisfaction? Researchers will compare the side of the mouth (cleaned with a dual-headed toothbrush) with the other side (cleaned with a single-headed toothbrush) in a randomized split-mouth design to see if the novel design leads to superior plaque control and better user experience.
Participants will:
Receive both toothbrush types (medium bristle) and identical toothpaste Be trained in the Bass brushing technique Use each toothbrush, twice daily, with the assigned toothbrush applied to its designated side of the mouth
Complete post-trial questionnaires on comfort, ease of use, and brushing time
Detailed description
This clinical trial explores the comparative effectiveness and user experience of a novel dual-headed toothbrush design versus a conventional single-headed toothbrush using a randomized split-mouth methodology among adult dental professionals. Dental professionals were selected as participants due to their consistent oral hygiene habits and ability to comply with standardized brushing protocols.
The study investigates whether the dual-headed design can offer improved plaque removal efficiency, reduced brushing time, and greater comfort during use-factors that are increasingly relevant to both clinical performance and patient compliance in oral hygiene tools. Participants were trained to use both toothbrushes following the Bass technique and instructed to brush twice daily, with the left and right sides of the mouth assigned to different brushes.
The trial design allows for within-subject comparison, minimizing confounding variables such as brushing technique, motivation, and dietary habits. In addition to clinical measurements, participants' subjective experiences were captured through structured questionnaires focusing on comfort, ease of maneuverability, and time spent brushing.
This investigation aims to provide evidence to guide the development of more ergonomic and time-efficient toothbrush designs that improve plaque control without compromising user comfort. Findings from this study may influence the recommendation of dental hygiene tools, particularly for individuals seeking more efficient oral hygiene practices or patients with limited dexterity or who rely on caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Headed Toothbrush | Experimental | Device: Dual-Headed Manual ToothbrushParticipants used a dual-headed manual toothbrush to clean one side of their mouth (maxillary and mandibular quadrants). Brushing was performed using the Bass technique, twice daily. This arm assesses the effectiveness, comfort, and time-efficiency of the novel dual-headed toothbrush design. |
| Single-Headed Toothbrush | Active comparator | Device: Conventional Single-Headed Manual ToothbrushParticipants used a conventional single-headed manual toothbrush to clean the other side of their mouth using the same brushing technique (Bass method), frequency (twice daily). This arm serves as the standard control for comparison in evaluating plaque removal and patient-reported comfort. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Dentists with a minimum of 26 natural teeth, good general health, and the ability to perform routine oral hygiene independently.
Key exclusion criteria (3 listed)
- • Participants with active periodontal disease, orthodontic appliances, or having recent oral surgery
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 |
|---|---|---|
| Dual-Headed Manual ToothbrushA novel toothbrush with a dual-headed design intended to clean both upper and lower buccal/ or upper and lower lingual/ palatal surfaces simultaneously. Participants were instructed to use this toothbrush on one side of the mouth only, twice daily using the Bass brushing technique. This intervention is evaluated for plaque removal efficacy, gingival health, brushing time, and patient comfort | Device | Dual-Headed Toothbrush |
| Conventional Single-Headed Manual ToothbrushA standard single-headed manual toothbrush used as the active control. Participants used this toothbrush on the other side of the mouth, with the same brushing technique (Bass method), frequency (twice daily). It serves as the comparator for assessing the performance of the dual-headed design. | Device | Single-Headed Toothbrush |
Primary outcome
Change in Plaque Index (PI)
Time frame: After 2, and 4 weeks of brushing
Difference in plaque scores between baseline and end of study on the left and right sides of the mouth, using the Silness and Löe Plaque Index. Scale: 0 = No plaque, 1 = A film of plaque, 2 = Moderate plaque, 3 = Abundant plaque Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
Gingival Index (GI)
Time frame: after 2 and 4 weeks
Löe \& Silness for GI Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding. Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
mSBI (modified sulcular bleeding index)
Time frame: after 2, and 4 weeks
mSBI (modified sulcular bleeding index): 0: no bleeding when a periodontal probe is passed along the gingival margin 1. isolated bleeding spots visible 2. Blood forms a confluent red line on margin 3. Heavy or profuse bleeding Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
2 secondary outcomes
Brushing Time Per Side
Time frame: Self-reported after 4 weeks
Patient satisfaction and comfort
Time frame: after 4 weeks
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 11 Sep 2025.
- Individual participant dataSharing planned: Yes. The following de-identified individual participant data (IPD) will be made available for research purposes: Demographic data: Age, gender, and handedness (for brushing consistency) Plaque Index scores: Baseline and post-intervention scores for both left and right sides Brushing time data: Self-reported average brushing time per side Toothbrush preference: Participant-reported final preference (dual-headed vs. single-headed)
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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.
SREIC Scientific Research Ethics and Innovative committee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Headed Manual Toothbrush and Conventional Single-Headed Manual Toothbrush in people with Dental Plaque Accumulation and Oral Hygiene Education Methods, run by Dar Al Uloom University at 1 site in Saudi Arabia.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 Saudi Arabia. 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?
Contact Sally ElHaddad, Assist. Prof. (+966555361062, s.elhaddad@dau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (PI) (time frame: After 2, and 4 weeks of brushing). The study lists 3 primary outcomes in all. 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 11 Sep 2025.