The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults

Sponsor
University of Malaya (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05418322
Collaborator
(none)
20
1
2
1.7
11.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Oral Hygiene Intervention
N/A

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:

  1. 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:
  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
The interventions and collection of data will be conducted by the same clinician. Therefore, both clinician and participants will not be blinded in this study given the nature of the interventions. However, as the participants will be randomized and allocated by an independent individual, blinding the clinician to the allocated interventions at the beginning of the trial, during baseline assessment, is possible.
Primary Purpose:
Supportive Care
Official Title:
The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults-A Randomized Clinical Trial
Actual Study Start Date :
May 10, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Verbal Oral Hygiene Intervention

Each participant will be given oral hygiene instruction verbally by a clinician face to face.

Behavioral: Oral Hygiene Intervention
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.

Other: Video-assisted Oral Hygiene Intervention

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
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.

Outcome Measures

Primary Outcome Measures

  1. Changes between the Full Mouth Plaque Score(FMPS) measurement at baseline (T0), at 2 weeks (T1), and at 4 weeks (T2) after the intervention [Baseline, 2 weeks and 4 weeks]

    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.

Secondary Outcome Measures

  1. Changes in Full Mouth Bleeding Score (FMBS) at baseline (T0) and at 4 weeks post intervention (T2) [Baseline and 4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universiti Malaya Kuala Lumpur Malaysia 50603

Sponsors and Collaborators

  • University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Lee Phey Ling, Principal investigator, University of Malaya
ClinicalTrials.gov Identifier:
NCT05418322
Other Study ID Numbers:
  • PheyLing UMalaya
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Lee Phey Ling, Principal investigator, University of Malaya

Study Results

No Results Posted as of Jun 28, 2022