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

NCT ID: NCT07121608

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2025-07-28

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.

Detailed Description

This study is designed to improve how dental anxiety is measured in patients with special needs (PSN) who receive care at the Special Care Dentistry (SCD) Clinic at Universiti Malaya (UM). Dental anxiety can make it harder for patients to visit the dentist, especially those with disabilities or complex medical conditions. To support better care, researchers want to understand which assessment method works best for this group.

The study focuses on two versions of a dental anxiety questionnaire:

I-MDAS (Inclusive Modified Dental Anxiety Scale) - a video-based tool with narration and subtitles to make it more accessible.

M-MDAS (Malay Modified Dental Anxiety Scale) - a standard written version in the Malay language.

The study will explore:

Whether there are differences in anxiety scores between I-MDAS and M-MDAS. Which version is easier for PSN to understand and complete. What personal, medical, or dental history factors are linked to higher or more severe dental anxiety.

What Will Participants Do?

Participants will first complete a pre-questionnaire about their background, including age, gender, education, type of special care needs, medical history, when they last saw a dentist, and whether they've had any unpleasant dental experiences.

Participants will then be randomly assigned to one of two groups:

Group A will complete the M-MDAS first, followed by I-MDAS. Group B will complete the I-MDAS first, followed by M-MDAS. There will be a one-week washout period between the two sessions to reduce any influence from the first questionnaire on the second.

After completing both tools, participants will also be asked which version they found easier or more comfortable to use.

By comparing the two tools and collecting feedback from PSN, the researchers aim to recommend a more inclusive and effective way to measure dental anxiety in this population.

Conditions

Dental Anxiety

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age 18 years and above

2. New and existing patients attending SCD clinic at Faculty of Dentistry, Universiti Malaya for elective dental treatment

3. Literate and able to understand the Malay language

4. Frankl behavioural rating scale of score 3 and 4

Exclusion Criteria

1. Patients who require other urgent dental treatments

2. Severe or complex learning or ID

3. Frankl behavioural rating scale of score 1 and 2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Aisyah Ahmad Fisal

Dental Lecturer (Special Care Dentistry)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Dental Lecturer (Special Care Dentistry)

Locations

Special Care Dentistry Clinic, Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, , Malaysia

Countries

Malaysia

Other Identifiers

UMG045E-2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DF CD2308/0019/2447 (P)

Identifier Type: -

Identifier Source: org_study_id