Effect of Direct Anterior Diastema Closure on Quality of Life and Dental Anxiety

March 18, 2026 updated by: fatih bedir, Recep Tayyip Erdogan University

Effect of Direct Anterior Diastema Closure Treatment on Oral Health-related Quality of Life and Dental Anxiety

The aim of this study is to evaluate the effects of non-invasive direct anterior diastema closure on dental anxiety and oral health-related quality of life in adults with maxillary anterior diastema. Direct composite resin restorations are widely used for diastema closure due to their minimally invasive nature, cost-effectiveness, and ability to be completed in a single clinical visit. However, limited information is available regarding the psychological and quality-of-life outcomes of this treatment.

In this prospective single-arm clinical study, adult participants presenting with anterior diastema receive non-invasive direct composite restorations for diastema closure. Dental anxiety and oral health-related quality of life are assessed using the Modified Dental Anxiety Scale (MDAS) and the Oral Health Impact Profile-14 (OHIP-14). Participants complete these questionnaires before treatment and three months after the restorative procedure. The study aims to determine whether direct anterior diastema closure improves oral health-related quality of life and reduces dental anxiety in affected individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Rize, Turkey (Türkiye), 53020
        • Recep Tayyip Erdogan University Faculty of Dentistry

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:

  • Adults aged 18 years or older
  • Absence of previous restorative treatment (including restorative, endodontic, or prosthetic procedures)
  • Periodontally healthy teeth
  • Presence of anterior diastema with a width of less than 2 mm
  • Absence of malocclusion
  • Good general systemic health
  • No use of anxiety-reducing pharmacological agents (e.g., sedatives, anxiolytics, or analgesics) prior to treatment

Exclusion Criteria:

  • Presence of cognitive or psychiatric disorders
  • History of substance abuse
  • Presence of malignant diseases
  • Presence of acute dental or periodontal conditions

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct Anterior Diastema Closure
Participants with maxillary anterior diastema received non-invasive direct anterior diastema closure using direct composite resin restorations.
Procedure: Direct Composite Resin Restoration for Anterior Diastema Closure
Non-invasive direct anterior diastema closure was performed using direct composite resin restorations following standard adhesive procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Health-Related Quality of Life (OHIP-14 Score)
Time Frame: Baseline and 3 months after treatment
Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14). The total score ranges from 0 to 56, with higher scores indicating poorer oral health-related quality of life.
Baseline and 3 months after treatment
Change in Dental Anxiety (MDAS Score)
Time Frame: Baseline and 3 months after treatment
Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 to 25, with higher scores indicating greater dental anxiety.
Baseline and 3 months after treatment

Collaborators and Investigators

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

Sponsor

Recep Tayyip Erdogan University

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 (Actual)

March 28, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Recep Tayyip Erdogan Universit

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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