Exploring Dental Anxiety in Special Needs Patients: A Comparison of I-MDAS and Malay MDAS

NCT07121608 | Completed

• 2 other identifiers: DF CD2308/0019/2447 (P)UMG045E-2024
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to better understand and improve how dental anxiety is measured in patients with special needs (PSN) who visit the Special Care Dentistry (SCD) Clinic at Universiti Malaya (UM). Researchers want to find out: Whether there is a difference in anxiety scores when using two versions of a dental anxiety questionnaire - the Inclusive Modified Dental Anxiety Scale (I-MDAS) and the Malay Modified Dental Anxiety Scale (M-MDAS). Which version PSN prefer or find easier to use. What factors may cause higher dental anxiety in these patients. What factors are linked to more severe levels of dental anxiety. Participants in this study will be randomly assigned to one of two groups. Each group will try out two different versions of a dental anxiety questionnaire - the written Malay Modified Dental Anxiety Scale (M-MDAS) and the Inclusive Modified Dental Anxiety Scale (I-MDAS), which includes video and narration. First, participants will fill out a short questionnaire about their background, such as age, gender, education, medical history, and dental experiences. Then, depending on their group, they will complete either the M-MDAS or the I-MDAS first. After a one-week break (called a "washout period"), they will complete the other version of the questionnaire. This allows researchers to compare both tools fairly and see which one is more effective and preferred by patients with special needs.

Conditions

Dental Anxiety

Keywords

Randomised cross-over; Patients with special needs; Dental anxiety; Modified Dental Anxiety Scale; Acceptability; Special Care Dentistry

Outcome Measures

Primary Outcomes (1)

• Agreement Between I-MDAS and M-MDAS in Measuring Dental Anxiety

  This outcome measures the level of agreement between the Inclusive Modified Dental Anxiety Scale (I-MDAS) and the Malay Modified Dental Anxiety Scale (M-MDAS) in assessing dental anxiety among patients with special needs (PSN). Agreement will be evaluated using statistical methods such as the intraclass correlation coefficient (ICC), Bland-Altman plot, and paired comparisons of total scores from both tools.

  Within 2 weeks of enrolment (completion of both I-MDAS and M-MDAS with 1-week washout period)

Secondary Outcomes (3)

• Acceptability of I-MDAS Compared to M-MDAS

  Immediately after completion of both anxiety scales (within 2 weeks of enrolment)

• Factors Associated With Severity of Dental Anxiety (I-MDAS Scores)

  At baseline (upon initial assessment during first visit)

• Factors Associated With Presence of Dental Anxiety (I-MDAS)

  At baseline (upon initial assessment during first visit)

Study Arms (2)

Group A (M-MDAS → I-MDAS)

Participants in this group will first complete the Malay Modified Dental Anxiety Scale (M-MDAS) in the initial session. After a one-week washout period, they will then complete the Inclusive Modified Dental Anxiety Scale (I-MDAS), which includes video, narration, and subtitles for improved accessibility.

Group B (I-MDAS → M-MDAS)

articipants in this group will begin by completing the Inclusive Modified Dental Anxiety Scale (I-MDAS) in the first session. Following a one-week washout period, they will complete the Malay Modified Dental Anxiety Scale (M-MDAS) in the second session.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with special needs attending Special Care Dentistry Clinic at Faculty of Dentistry, Universiti Malaya

You may qualify if:

• Age 18 years and above
• New and existing patients attending SCD clinic at Faculty of Dentistry, Universiti Malaya for elective dental treatment
• Literate and able to understand the Malay language
• Frankl behavioural rating scale of score 3 and 4

You may not qualify if:

• Patients who require other urgent dental treatments
• Severe or complex learning or ID
• Frankl behavioural rating scale of score 1 and 2

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Special Care Dentistry Clinic, Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location

Study Officials

• Aisyah Ahmad Fisal, BDS, MSCD RCSEd, D.Ch.Dent SCD

  Dental Lecturer (Special Care Dentistry)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Lecturer (Special Care Dentistry)

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: March 14, 2025
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)