Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulf Medical University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years or older
Patients undergoing fixed orthodontic treatment
Diagnosis of biofilm-induced gingivitis
Presence of interdental spaces suitable for calibrated interdental brush use
Disqualifiers
Presence of systemic diseases affecting gingival health (e.g., uncontrolled diabetes)
Use of medications known to influence gingival conditions (e.g., phenytoin, cyclosporine, calcium channel blockers)
History of chemotherapy or radiotherapy in the head and neck region
Current smokers
Trial design
Design model
Parallel
Treatments tested in this trial
Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training
BehavioralParticipants 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 2 weeks, 1 month, and 3 months to ensure adherence and correct oral hygiene performance.
Conventional Oral Hygiene Instruction
BehavioralParticipants 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 2 weeks, 1 month, and 3 months.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: iTOP Oral Hygiene Training with Calibrated Interdental BrushesExperimental treatment 1 intervention
Group B: Conventional Oral Hygiene InstructionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at Baseline and 3 monthsSecondary outcomes
1
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.
Time frame
Baseline and 3 months2
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.
Time frame
Baseline and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: