The Effects of Oral Hygiene Interventions Prior Orthodontic Treatment in Adults

NCT05418322 | Unknown

• 1 other identifier: PheyLing UMalaya
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Hygiene; Adult

Keywords

Oral hygiene interventions; Adult; Prior orthodontic treatment

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• Changes in Full Mouth Bleeding Score (FMBS) at baseline (T0) and at 4 weeks post intervention (T2)

  Baseline and 4 weeks

Study Arms (2)

Verbal Oral Hygiene Intervention

OTHER

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

Behavioral: Oral Hygiene Intervention

Video-assisted Oral Hygiene Intervention

OTHER

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

Interventions

Oral Hygiene Intervention 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.

Verbal Oral Hygiene Intervention; Video-assisted Oral Hygiene Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (4)

• 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.

  PMID: 8432102 BACKGROUND

• 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.

  PMID: 15312097 BACKGROUND

• 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.

  PMID: 32592553 BACKGROUND

• 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.

  PMID: 25992985 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: May 10, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

MY (1)