The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults

NCT ID: NCT05418322

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Hygiene Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Verbal Oral Hygiene Intervention

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

Group Type OTHER

Oral Hygiene Intervention

Intervention Type BEHAVIORAL

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.

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

Group Type OTHER

Oral Hygiene Intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Lee Phey Ling

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universiti Malaya

Kuala Lumpur, , Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

Lew KK. Attitudes and perceptions of adults towards orthodontic treatment in an Asian community. Community Dent Oral Epidemiol. 1993 Feb;21(1):31-5. doi: 10.1111/j.1600-0528.1993.tb00715.x.

Reference Type BACKGROUND
PMID: 8432102 (View on PubMed)

Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.

Reference Type BACKGROUND
PMID: 15312097 (View on PubMed)

Soldo M, Matijevic J, Malcic Ivanisevic A, Cukovic-Bagic I, Marks L, Nikolov Boric D, Jukic Krmek S. Impact of oral hygiene instructions on plaque index in adolescents. Cent Eur J Public Health. 2020 Jun;28(2):103-107. doi: 10.21101/cejph.a5066.

Reference Type BACKGROUND
PMID: 32592553 (View on PubMed)

Cardoso Mde A, Saraiva PP, Maltagliati LA, Rhoden FK, Costa CC, Normando D, Capelozza Filho L. Alterations in plaque accumulation and gingival inflammation promoted by treatment with self-ligating and conventional orthodontic brackets. Dental Press J Orthod. 2015 Mar-Apr;20(2):35-41. doi: 10.1590/2176-9451.20.2.035-041.oar.

Reference Type BACKGROUND
PMID: 25992985 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PheyLing UMalaya

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.