Comparasion of Dental Anxiety in First Time Complete Denture Patients

NCT07597057 | Not Yet Recruiting

• 1 other identifier: DSG_2021_019_3780
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Edentulous Mouth; Dental Anxiety

Keywords

complete denture; dental anxiety scale; prosthodontics; edentulism

Outcome Measures

Primary Outcomes (1)

• 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."

  Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)

Study Arms (1)

Complete Denture Treatment

EXPERIMENTAL

Edentulous patients (aged 40-70) receiving their first-time conventional complete dentures.

Procedure: conventional complete denture fabrication

Interventions

conventional complete denture fabrication PROCEDURE

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).

Complete Denture Treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Khyber College of dentistry: lead

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Dental Anxiety Scale for edentulous subjects will be used to measure participant anxiety. This is a 4-item (or 5-item, depending on your specific version) questionnaire where each item is scored on a scale of 1 to 5. Total scores range from a minimum of 4 to a maximum of 20 (or 5 to 25). Higher scores indicate higher levels of dental anxiety. A score of 19 or higher is considered a cut-off for high anxiety.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident (or your current designation at the college).

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05