The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults

Study Overview
=================
Brief Summary
-----------------
Orthodontic treatment has many recognized benefits such as enhancing esthetics and improving self-esteem in patients. However, like any other dental treatments, a successful orthodontic treatment requires patient cooperation, especially oral hygiene compliance. Dental plaque that builds upon the orthodontic brackets in a poor oral environment consists of pathogenic biofilms that can lead to undesirable complications such as white spot lesions, gingivitis, and periodontal breakdown. Poor oral hygiene during orthodontic treatment often results in poor treatment quality and prolonged treatment duration. Fixed appliances increase the retention areas for plaque accumulation and this often makes maintaining good oral hygiene a challenge for the patients. Therefore, effective oral hygiene interventions are key in improving patients' knowledge, influencing good oral hygiene behaviors and ensuring patients can exercise good practices daily at home. Oral hygiene education given to prospective orthodontic patients will allow them to understand their role and responsibilities in maintaining good oral care during treatment. This will help instill lasting good oral hygiene habits that can be maintained during the fixed appliance stage of treatment, thus reducing possible future treatment complications. In this study, the investigators evaluate the effects of verbal and video-assisted oral hygiene interventions on patients' oral hygiene prior to orthodontic treatment.

Detailed Description
-----------------
The present study evaluates the effectiveness of different oral hygiene interventions on patients' oral hygiene prior to orthodontic treatment. Participants will be recruited from the Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, University Malaya and will be selected from the postgraduate orthodontic treatment waiting list. Patients meeting the selection criteria will be offered the opportunity to participate in the study during the visit prior to the orthodontic appliance placement. The participants will be equally distributed into two groups as follows: Group 1: Verbal oral hygiene intervention Group 2: Video-assisted oral hygiene intervention A block randomization technique with 1:1 ratio of 5:5:5:5 fixed block sizes with no stratification will be used to randomly allocate the participants into the two interventions. After baseline recording, full mouth supragingival scaling and treatments to remove any plaque retentive factor will be given to participants with the following measure: i) Baseline full mouth plaque score >10% or ii) Baseline full mouth bleeding score >10% Following treatment, each participant from group 1 will be given oral hygiene instruction verbally by a clinician face to face. In contrast, each participant from group 2 will be required to watch a pre-recorded oral hygiene instruction video via a tablet in a separate room away from the clinician. The oral hygiene instructions given in the two methods will be prepared in Bahasa Malaysia and English versions with the same content to avoid bias. The aim of the study is to evaluate the effects of verbal and video-assisted oral hygiene interventions on patients' oral hygiene prior to orthodontic treatment. The objectives of the study are: To determine the changes in Full-mouth Plaque Score (FMPS) and Full-mouth Bleeding Score (FMBS) for both verbal and video groups after receiving oral hygiene instruction. To compare the outcomes of Full-mouth Plaque Score (FMPS) and Full-mouth Bleeding Score (FMBS) between patients receiving verbal and video-assisted oral hygiene instruction.

Official Title
-----------------
The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults-A Randomized Clinical Trial

Conditions
-----------------
Oral Hygiene, Adult

Intervention / Treatment
-----------------
* Behavioral: Oral Hygiene Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Plan to undergo orthodontic treatment and is eligible for orthodontic treatment with fixed appliances. Clinical gingival health (<10% bleeding score) or localized gingivitis (10%-30% bleeding score) or generalized gingivitis (>30% bleeding score) Presence of BPE code 0/1/2 with no obvious evidence of interdental recession Have at least 20 teeth Able to understand Bahasa Malaysia and English languages Exclusion Criteria: Presence of BPE code 3/4 Current or previous history of periodontitis Smokers Severe or chronic illnesses (such as diabetes, cardiovascular diseases, stroke, etc) Physically impaired Orofacial deformities History of previous orthodontic treatment Intake of antibiotics within 6 months before and during the study period Taking drugs that influence gingival inflammation or bleeding (eg anticoagulants, cortisone) Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Verbal Oral Hygiene Intervention<br>Each participant will be given oral hygiene instruction verbally by a clinician face to face. | Behavioral: Oral Hygiene Intervention<br>* The oral hygiene instructions given in the two methods will be prepared in Bahasa Malaysia and English versions with the same content to avoid bias. The oral hygiene education will be validated by three dental specialists. A similar large dental teeth model and toothbrush will be used for the purpose of oral hygiene demonstration.<br>|
| Other: Video-assisted Oral Hygiene Intervention<br>Each participant will be required to watch a pre-recorded oral hygiene instruction video via a tablet in a separate room away from the clinician | Behavioral: Oral Hygiene Intervention<br>* The oral hygiene instructions given in the two methods will be prepared in Bahasa Malaysia and English versions with the same content to avoid bias. The oral hygiene education will be validated by three dental specialists. A similar large dental teeth model and toothbrush will be used for the purpose of oral hygiene demonstration.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes between the Full Mouth Plaque Score(FMPS) measurement at baseline (T0), at 2 weeks (T1), and at 4 weeks (T2) after the intervention | Presence or absence of plaque deposits on each tooth surface (mesial, distal, buccal and lingual/palatal) in the dentition is recorded in a dichotomous manner. The plaque deposits will be disclosed using a disclosing solution to facilitate their detection. The presence of plaque is recorded in a plaque chart. | Baseline, 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Full Mouth Bleeding Score (FMBS) at baseline (T0) and at 4 weeks post intervention (T2) | Presence or absence of gingival bleeding on each tooth surface (mesial, distal, buccal and lingual/palatal) in the dentition is recorded in a dichotomous manner. The FMBS will be performed through gentle probing of the gingival crevice on each tooth surface. A positive finding will be recorded if bleeding occurs within 10 seconds. The presence of bleeding is recorded in a FMBS chart. | Baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral hygiene interventions, Adult, Prior orthodontic treatment