Dental AnxietyMDASNCT07121608
Exploring Dental Anxiety in Special Needs Patients: A Comparison of I-MDAS and Malay MDAS
An observational study of Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Mar 2025to 28 Jul 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with special needs attending Special Care Dentistry Clinic at Faculty of Dentistry, Universiti Malaya
Who may be able to join
- 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
Who cannot join
- Patients who require other urgent dental treatments
- Severe or complex learning or ID
- Frankl behavioural rating scale of score 1 and 2
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Special Care Dentistry Clinic, Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, 50603
About this study
Official title: Exploring Dental Anxiety in Patients With Special Needs: A Randomised Cross-over Study of I-MDAS and Malay Version of MDAS
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).
Read more
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.
Read the 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
- Keywords
- Randomised cross-over, Patients with special needs, Dental anxiety, Modified Dental Anxiety Scale, Acceptability, Special Care Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Acceptability will be measured using a structured questionnaire consisting of five Likert-scale items (1 = strongly disagree to 5 = strongly agree) that assess participants' agreement with statements about their experience using the Malay Modified Dental Anxiety Scale (M-MDAS) and the Inclusive Modified Dental Anxiety Scale (I-MDAS). Items assess ease of understanding, usability, comfort, satisfaction, and future preference. The total acceptability score for each version will be calculated and compared between tools. Preference for I-MDAS over M-MDAS will also be captured through a forced-choice item.
Measured: Immediately after completion of both anxiety scales (within 2 weeks of enrolment)
Factors Associated With Severity of Dental Anxiety (I-MDAS Scores)
This outcome investigates demographic, medical, and dental-related factors linked to the severity of dental anxiety, as measured by the I-MDAS total score. Statistical analyses such as multiple linear regression and group comparisons (e.g., ANOVA or Kruskal-Wallis) will be used to identify associations.
The I-MDAS is scored on a scale from 5 to 25, with higher scores indicating greater levels of dental anxiety (i.e., a worse outcome).
Measured: At baseline (upon initial assessment during first visit)
Factors Associated With Presence of Dental Anxiety (I-MDAS)
This outcome identifies sociodemographic and clinical characteristics that are associated with the presence of dental anxiety (based on a defined cut-off score on the I-MDAS). Chi-square tests, Fisher's exact tests, and logistic regression will be used to explore associations between participant factors and anxiety status.
The I-MDAS is scored on a scale from 5 to 25, with higher scores indicating greater levels of dental anxiety (i.e., a worse outcome).
Measured: At baseline (upon initial assessment during first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start14 Mar 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisyah Ahmad Fisal, University of Malaya
- Investigators
- Aisyah Ahmad Fisal, BDS, MSCD RCSEd, D.Ch.Dent SCD, Principal investigator, Dental Lecturer (Special Care Dentistry)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121608
- Sponsor's protocol ID
- DF CD2308/0019/2447 (P)
- Other IDs
- UMG045E-2024
- Acronym
- MDAS
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan to share individual participant data (IPD). The dataset will not be made publicly available due to concerns about participant privacy and data sensitivity in a special needs population.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Dental Anxiety in Patients With Special Needs: A Randomised Cross-over Study of I-MDAS and Malay Version of MDAS
- ClinicalTrials.gov ID
- NCT07121608
- Acronym / sponsor ID
- MDAS / DF CD2308/0019/2447 (P)
- Conditions
- Dental Anxiety
- Keywords
- Randomised cross-over, Patients with special needs, Dental anxiety, Modified Dental Anxiety Scale, Acceptability, Special Care Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with special needs attending Special Care Dentistry Clinic at Faculty of Dentistry, Universiti Malaya
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who require other urgent dental treatments
- Severe or complex learning or ID
- Frankl behavioural rating scale of score 1 and 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between I-MDAS and M-MDAS in Measuring Dental Anxiety
Time frame: Within 2 weeks of enrolment (completion of both I-MDAS and M-MDAS with 1-week washout period)
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.
3 secondary outcomes
Acceptability of I-MDAS Compared to M-MDAS
Time frame: Immediately after completion of both anxiety scales (within 2 weeks of enrolment)
Factors Associated With Severity of Dental Anxiety (I-MDAS Scores)
Time frame: At baseline (upon initial assessment during first visit)
Factors Associated With Presence of Dental Anxiety (I-MDAS)
Time frame: At baseline (upon initial assessment during first visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. No, we do not plan to share individual participant data (IPD). The dataset will not be made publicly available due to concerns about participant privacy and data sensitivity in a special needs population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aisyah Ahmad Fisal, BDS, MSCD RCSEd, D.Ch.Dent SCD principal investigator
Dental Lecturer (Special Care Dentistry)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between I-MDAS and M-MDAS in Measuring Dental Anxiety (time frame: Within 2 weeks of enrolment (completion of both I-MDAS and M-MDAS with 1-week washout period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.