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Not yet recruiting NCT07597057

Comparasion of Dental Anxiety in First Time Complete Denture Patients

No phase Interventional Edentulous Mouth Dental Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional complete denture fabrication.
Who it may be relevant to
Registry conditions: Edentulous Mouth, Dental Anxiety. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Change in Dental Anxiety Scale (DAS) Score [Time frame: Baseline (primary impression appointment) and 5 weeks (denture insertion appointment)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07597057 · DSG_2021_019_3780

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗