Gingivitis, Orthodontic Treatment
Conditions
Keywords
Interdental Brushes, iTOP, Oral Hygiene Education, Approximal Plaque Index, Plaque Control
Brief 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 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.
Interventions
BEHAVIORALIndividually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training
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.
BEHAVIORALConventional Oral Hygiene Instruction
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.
Sponsors
Gulf Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Approximal Plaque Index (API) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Index (GI) | Baseline and 3 months | 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. |
| Change in Full Mouth Bleeding Score (FMBS) | Baseline and 3 months | 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. |
| Patient-Reported Outcome Measures (PROMs) | at 3 months | Participant experience, satisfaction, and compliance-related behaviors will be evaluated using a structured exit survey across five key domains: 1. Acceptability and interdental brush handling (good / fair / poor) 2. Procedure-related discomfort (minimal / moderate / high) 3. Self-perceived efficacy regarding cleanliness and bleeding reduction (good / fair / poor) 4. Participant satisfaction with the clarity and usefulness of assigned instructions (good / fair / poor) 5. 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 |
Countries
United Arab Emirates
Contacts
STUDY_CHAIRMohamed Atef Sayed
Gulf Medical University
PRINCIPAL_INVESTIGATORFatema Ramadhan, M.D.S
Gulf Medical University
STUDY_DIRECTORBhavna Kukreja, Ph.D.
Gulf Medical University
Outcome results
None listed