Comparasion of Dental Anxiety in First Time Complete Denture Patients

May 13, 2026 updated by: Maham Shabbir, Khyber College of dentistry

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complete Denture Treatment
Edentulous patients (aged 40-70) receiving their first-time conventional complete dentures.
Procedure: conventional complete denture fabrication
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber College of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSG_2021_019_3780

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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