GingivitisNCT07468773
Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients
A study testing Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training and Conventional Oral Hygiene Instruction in people with Gingivitis and Orthodontic Treatment, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
This randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Orthodontic Treatment
- What is being tested?
- Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training and Conventional Oral Hygiene Instruction
- 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
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Systemically healthy adult patients aged 18 years or older
- Currently undergoing fixed orthodontic treatment
- Clinical diagnosis of generalized biofilm-induced gingivitis
- Adequate manual dexterity to use calibrated interdental brushes
- Willingness and ability to comply with assigned oral hygiene protocols and complete all 3-month follow-up visits
Who cannot join
- History of systemic diseases that influence gingival health or tissue response (e.g., uncontrolled diabetes)
- Use of medications known to affect gingival tissues (e.g., phenytoin, cyclosporine, calcium channel blockers)
- History of chemotherapy or radiotherapy in the head and neck region
- Current tobacco smokers or users of smokeless tobacco
- Pregnant or lactating women
- Presence of clinical attachment loss (periodontal pockets or gingival recession)
- Presence of open proximal carious lesions or defective restorations causing plaque retention
- Physical or cognitive conditions impeding independent oral hygiene performance
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: Effect of Individually Trained Oral Prophylaxis (iTOP) Versus Conventional Oral Hygiene Instruction on Gingival Health in Orthodontic Patients Using Calibrated Interdental Brushes: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed with gingivitis.
Sixty orthodontic patients underwent professional mechanical plaque removal and received oral hygiene instruction using calibrated interdental brushes. Participants were randomly assigned to either the iTOP training group or the conventional education group.
Clinical outcomes including Approximal Plaque Index (API), Gingival Index (GI), and Full Mouth Bleeding Score (FMBS) were assessed at baseline and after three months to determine the effectiveness of the educational interventions on plaque control and gingival health.
Read the detailed description
Orthodontic patients with fixed appliances are at increased risk for plaque accumulation and gingival inflammation due to the presence of plaque-retentive surfaces created by orthodontic brackets and wires. Effective oral hygiene education is therefore essential to maintain periodontal health during orthodontic treatment.
Traditional oral hygiene education methods, such as model demonstration and video instruction, provide general guidance but often lack individualized feedback and psychomotor skill training.
The Individually Trained Oral Prophylaxis (iTOP) method introduces a personalized hands-on approach using the "Touch-to-Teach" concept, where clinicians guide the patient's hand to demonstrate correct interdental cleaning techniques using calibrated interdental brushes.
This study compares the effectiveness of the iTOP method with conventional oral hygiene instruction in orthodontic patients diagnosed with gingivitis. The primary outcome measure is the change in the Approximal Plaque Index (API), while secondary outcomes include the Gingival Index (GI) and Full Mouth Bleeding Score (FMBS). These parameters are assessed at baseline and after a three-month follow-up period to determine improvements in plaque control and gingival health.
- Conditions
- Gingivitis, Orthodontic Treatment
- Being tested
- Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training, Conventional Oral Hygiene Instruction
- Keywords
- Interdental Brushes, iTOP, Oral Hygiene Education, Approximal Plaque Index, Plaque Control
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene TrainingBehavioural
Also called Touch-to-Teach Technique, Personalized
Participants receive individualized oral hygiene training using the Individually Trained Oral Prophylaxis (iTOP) method. The intervention is delivered in a one-to-one chairside session and uses the Touch-to-Teach technique, where the clinician guides the participant's hand to demonstrate correct toothbrushing and interdental cleaning movements. Calibrated interdental brushes are selected based on individual interdental space measurements using a color-coded interdental access probe. Participants practice the technique under supervision until proper technique is achieved. Reinforcement sessions are provided at 1 month and 3 months to ensure adherence and correct oral hygiene performance.
Conventional Oral Hygiene InstructionBehavioural
Also called Model Demonstration and Video-Based Oral Hygiene Education
Participants receive conventional oral hygiene education consisting of verbal explanation, model demonstration, and video-based instruction illustrating standard toothbrushing and interdental cleaning techniques. This educational approach provides visual and verbal guidance but does not include individualized calibration of interdental brushes or hands-on correction of brushing technique. Participants are instructed to brush twice daily and perform interdental cleaning once daily using the provided oral hygiene kit. Reinforcement sessions using the same demonstration and video-based instruction are conducted at 1 month and 3 months.
| Study group | Role | What they receive |
|---|---|---|
| iTOP Oral Hygiene Training with Calibrated Interdental Brushes | Experimental | Experimental Receives: Behavioral: Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training |
| Conventional Oral Hygiene Instruction | Active comparator | Participants receive conventional oral hygiene education through model demonstration and video-based instruction. The session includes verbal explanation of toothbrushing and interdental cleaning techniques without individualized hands-on training. Reinforcement sessions are conducted at 1 month and 3 months. Receives: Behavioral: Conventional Oral Hygiene Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Approximal Plaque Index (API)
The Approximal Plaque Index (API) is used to evaluate plaque accumulation at interdental surfaces. Plaque is disclosed using a disclosing agent and each approximal surface is scored as the presence or absence of plaque. The API score is calculated as the percentage of interdental surfaces with visible plaque relative to the total number of surfaces examined. Lower values indicate improved plaque control.
Measured: at Baseline and 3 months
Secondary outcomes (3)
Change in Gingival Index (GI)
The Gingival Index is used to assess the severity of gingival inflammation. The gingiva around each tooth is evaluated at four surfaces (mesial, distal, facial, and lingual) and scored from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation with spontaneous bleeding. Lower scores indicate improvement in gingival health.
Measured: Baseline and 3 months
Change in Full Mouth Bleeding Score (FMBS)
The Full Mouth Bleeding Score evaluates gingival inflammation by recording bleeding on probing at six sites per tooth. The score is calculated as the percentage of sites that show bleeding after gentle probing. Higher percentages indicate greater gingival inflammation, while lower values reflect improved gingival health.
Measured: Baseline and 3 months
Patient-Reported Outcome Measures (PROMs)
Participant experience, satisfaction, and compliance-related behaviors will be evaluated using a structured exit survey across five key domains:
- Acceptability and interdental brush handling (good / fair / poor)
- Procedure-related discomfort (minimal / moderate / high)
- Self-perceived efficacy regarding cleanliness and bleeding reduction (good / fair / poor)
- Participant satisfaction with the clarity and usefulness of assigned instructions (good / fair / poor)
- Adherence to daily interdental cleaning regimen (Yes / No)
In addition, specific barriers to routine use (e.g., procedural confusion, technique uncertainty, lack of time, or lack of motivation) are recorded
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start30 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Atef Sayed, Study chair, Gulf Medical UniversityFatema Ramadhan, M.D.S, Principal investigator, Gulf Medical UniversityBhavna Kukreja, Ph.D., Study director, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468773
- Sponsor's protocol ID
- IRB-COD-STD-67-FEB-2026
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individually Trained Oral Prophylaxis (iTOP) Versus Conventional Oral Hygiene Instruction on Gingival Health in Orthodontic Patients Using Calibrated Interdental Brushes: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07468773
- Acronym / sponsor ID
- IRB-COD-STD-67-FEB-2026
- Conditions
- Gingivitis, Orthodontic Treatment
- Keywords
- Interdental Brushes, iTOP, Oral Hygiene Education, Approximal Plaque Index, Plaque Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Mar 2026 (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 randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed with gingivitis.
Sixty orthodontic patients underwent professional mechanical plaque removal and received oral hygiene instruction using calibrated interdental brushes. Participants were randomly assigned to either the iTOP training group or the conventional education group.
Clinical outcomes including Approximal Plaque Index (API), Gingival Index (GI), and Full Mouth Bleeding Score (FMBS) were assessed at baseline and after three months to determine the effectiveness of the educational interventions on plaque control and gingival health.
Detailed description
Orthodontic patients with fixed appliances are at increased risk for plaque accumulation and gingival inflammation due to the presence of plaque-retentive surfaces created by orthodontic brackets and wires. Effective oral hygiene education is therefore essential to maintain periodontal health during orthodontic treatment.
Traditional oral hygiene education methods, such as model demonstration and video instruction, provide general guidance but often lack individualized feedback and psychomotor skill training.
The Individually Trained Oral Prophylaxis (iTOP) method introduces a personalized hands-on approach using the "Touch-to-Teach" concept, where clinicians guide the patient's hand to demonstrate correct interdental cleaning techniques using calibrated interdental brushes.
This study compares the effectiveness of the iTOP method with conventional oral hygiene instruction in orthodontic patients diagnosed with gingivitis. The primary outcome measure is the change in the Approximal Plaque Index (API), while secondary outcomes include the Gingival Index (GI) and Full Mouth Bleeding Score (FMBS). These parameters are assessed at baseline and after a three-month follow-up period to determine improvements in plaque control and gingival health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTOP Oral Hygiene Training with Calibrated Interdental Brushes | Experimental | Behavioral: Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene TrainingExperimental |
| Conventional Oral Hygiene Instruction | Active comparator | Behavioral: Conventional Oral Hygiene InstructionParticipants receive conventional oral hygiene education through model demonstration and video-based instruction. The session includes verbal explanation of toothbrushing and interdental cleaning techniques without individualized hands-on training. Reinforcement sessions are conducted at 1 month and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy adult patients aged 18 years or older
- Currently undergoing fixed orthodontic treatment
- Clinical diagnosis of generalized biofilm-induced gingivitis
- Adequate manual dexterity to use calibrated interdental brushes
- Willingness and ability to comply with assigned oral hygiene protocols and complete all 3-month follow-up visits
Key exclusion criteria (8 listed)
- History of systemic diseases that influence gingival health or tissue response (e.g., uncontrolled diabetes)
- Use of medications known to affect gingival tissues (e.g., phenytoin, cyclosporine, calcium channel blockers)
- History of chemotherapy or radiotherapy in the head and neck region
- Current tobacco smokers or users of smokeless tobacco
- Pregnant or lactating women
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 |
|---|---|---|
| Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene TrainingAlso: Touch-to-Teach Technique, PersonalizedParticipants receive individualized oral hygiene training using the Individually Trained Oral Prophylaxis (iTOP) method. The intervention is delivered in a one-to-one chairside session and uses the Touch-to-Teach technique, where the clinician guides the participant's hand to demonstrate correct toothbrushing and interdental cleaning movements. Calibrated interdental brushes are selected based on individual interdental space measurements using a color-coded interdental access probe. Participants practice the technique under supervision until proper technique is achieved. Reinforcement sessions are provided at 1 month and 3 months to ensure adherence and correct oral hygiene performance. | Behavioural | iTOP Oral Hygiene Training with Calibrated Interdental Brushes |
| Conventional Oral Hygiene InstructionAlso: Model Demonstration and Video-Based Oral Hygiene EducationParticipants receive conventional oral hygiene education consisting of verbal explanation, model demonstration, and video-based instruction illustrating standard toothbrushing and interdental cleaning techniques. This educational approach provides visual and verbal guidance but does not include individualized calibration of interdental brushes or hands-on correction of brushing technique. Participants are instructed to brush twice daily and perform interdental cleaning once daily using the provided oral hygiene kit. Reinforcement sessions using the same demonstration and video-based instruction are conducted at 1 month and 3 months. | Behavioural | Conventional Oral Hygiene Instruction |
Primary outcome
Change in Approximal Plaque Index (API)
Time frame: at Baseline and 3 months
The Approximal Plaque Index (API) is used to evaluate plaque accumulation at interdental surfaces. Plaque is disclosed using a disclosing agent and each approximal surface is scored as the presence or absence of plaque. The API score is calculated as the percentage of interdental surfaces with visible plaque relative to the total number of surfaces examined. Lower values indicate improved plaque control.
3 secondary outcomes
Change in Gingival Index (GI)
Time frame: Baseline and 3 months
Change in Full Mouth Bleeding Score (FMBS)
Time frame: Baseline and 3 months
Patient-Reported Outcome Measures (PROMs)
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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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. This study is not recruiting at the moment.
Mohamed Atef Sayed study chair
Gulf Medical University
Fatema Ramadhan, M.D.S principal investigator
Gulf Medical University
Bhavna Kukreja, Ph.D. study director
Gulf Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training and Conventional Oral Hygiene Instruction in people with Gingivitis and Orthodontic Treatment, run by Gulf Medical University at 1 site in United Arab Emirates.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 Aug 2026. 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Approximal Plaque Index (API) (time frame: at Baseline and 3 months). 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 19 Aug 2026.