Edentulous MouthNCT07597057
Comparasion of Dental Anxiety in First Time Complete Denture Patients
A study testing conventional complete denture fabrication in people with Edentulous Mouth and Dental Anxiety, run by Khyber College of dentistry.
Trial summary
This quasi-experimental study compares dental anxiety levels in edentulous patients at two specific clinical points: the primary impression appointment and the denture insertion appointment. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Edentulous Mouth, Dental Anxiety
- What is being tested?
- conventional complete denture fabrication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Edentulous patients (missing all teeth) requiring first-time complete dentures.
Exclusion Criteria: History of previous denture use, severe cognitive impairment, or systemic diseases contraindicating dental procedures.
About this study
Official title: Comparison of Dental Anxiety Level in Edentulous Patients Before and After Seeking Complete Denture Treatment for the First Time: A Quasi-Experimental Study
This quasi-experimental study compares dental anxiety levels in edentulous patients at two specific clinical points: the primary impression appointment and the denture insertion appointment. The study aims to determine if the process of receiving first-time complete dentures significantly impacts patient anxiety levels. Data will be collected from 70 participants at the Khyber College of Dentistry over a five-week interval between the two appointments
Read the detailed description
Participants aged 40-70 requiring first-time complete dentures will be enrolled via non-probability consecutive sampling at the Prosthodontic Department of Khyber College of Dentistry. Dental anxiety will be measured using a specific 5-item Dental Anxiety Scale for edentulous subjects at the first visit (primary impression) and again at the insertion appointment, approximately five weeks later. A cut-off score of 19 on the scale will distinguish high-level from low-level anxiousness. Statistical analysis, including paired t-tests (for normally distributed data) or Wilcoxon signed-rank tests, will be used to compare the mean difference in dental anxiety levels at the two time points.
- Conditions
- Edentulous Mouth, Dental Anxiety
- Being tested
- conventional complete denture fabrication
- Keywords
- complete denture, dental anxiety scale, prosthodontics, edentulism
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional complete denture fabricationProcedure or surgery
A standard 5-step clinical process: primary impression, secondary impression, jaw relation, trial, and insertion. Dental anxiety is assessed using the Dental Anxiety Scale at the baseline (primary impression) and final follow-up (insertion).
| Study group | Role | What they receive |
|---|---|---|
| Complete Denture Treatment | Experimental | Edentulous patients (aged 40-70) receiving their first-time conventional complete dentures. Receives: Procedure: conventional complete denture fabrication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Anxiety Scale (DAS) Score
The Dental Anxiety Scale will be used to measure the level of anxiety in edentulous patients. It consists of items scored on a 5-point scale. Total scores range from a minimum of 4 (no anxiety) to a maximum of 20 (extreme anxiety). A higher score indicates a higher level of dental anxiety."
Measured: Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental study using a single-group, pre-post design. All participants receive the same intervention (fabrication of conventional complete dentures). Dental anxiety is measured at baseline (primary impression) and at the final follow-up (denture insertion) to determine the mean difference in anxiety levels within the group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber College of dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maham Shabbir, Khyber College of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597057
- Sponsor's protocol ID
- DSG_2021_019_3780
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dental Anxiety Level in Edentulous Patients Before and After Seeking Complete Denture Treatment for the First Time: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07597057
- Acronym / sponsor ID
- DSG_2021_019_3780
- Conditions
- Edentulous Mouth, Dental Anxiety
- Keywords
- complete denture, dental anxiety scale, prosthodontics, edentulism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Khyber College of dentistryUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 May 2026 (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 quasi-experimental study compares dental anxiety levels in edentulous patients at two specific clinical points: the primary impression appointment and the denture insertion appointment. The study aims to determine if the process of receiving first-time complete dentures significantly impacts patient anxiety levels. Data will be collected from 70 participants at the Khyber College of Dentistry over a five-week interval between the two appointments
Detailed description
Participants aged 40-70 requiring first-time complete dentures will be enrolled via non-probability consecutive sampling at the Prosthodontic Department of Khyber College of Dentistry. Dental anxiety will be measured using a specific 5-item Dental Anxiety Scale for edentulous subjects at the first visit (primary impression) and again at the insertion appointment, approximately five weeks later. A cut-off score of 19 on the scale will distinguish high-level from low-level anxiousness. Statistical analysis, including paired t-tests (for normally distributed data) or Wilcoxon signed-rank tests, will be used to compare the mean difference in dental anxiety levels at the two time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental study using a single-group, pre-post design. All participants receive the same intervention (fabrication of conventional complete dentures). Dental anxiety is measured at baseline (primary impression) and at the final follow-up (denture insertion) to determine the mean difference in anxiety levels within the group
| Arm | Type | Receives |
|---|---|---|
| Complete Denture Treatment | Experimental | Procedure: conventional complete denture fabricationEdentulous patients (aged 40-70) receiving their first-time conventional complete dentures. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional complete denture fabricationA standard 5-step clinical process: primary impression, secondary impression, jaw relation, trial, and insertion. Dental anxiety is assessed using the Dental Anxiety Scale at the baseline (primary impression) and final follow-up (insertion). | Procedure or surgery | Complete Denture Treatment |
Primary outcome
Change in Dental Anxiety Scale (DAS) Score
Time frame: Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)
The Dental Anxiety Scale will be used to measure the level of anxiety in edentulous patients. It consists of items scored on a 5-point scale. Total scores range from a minimum of 4 (no anxiety) to a maximum of 20 (extreme anxiety). A higher score indicates a higher level of dental anxiety."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing conventional complete denture fabrication in people with Edentulous Mouth and Dental Anxiety, run by Khyber College of dentistry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Dental Anxiety Scale (DAS) Score (time frame: Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)). 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 19 May 2026.