Completed

NCT Number: NCT07480551

Effect of Direct Anterior Diastema Closure on 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.

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Key information

Conditions

Maxillary Anterior Diastema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, 53020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct Composite Resin Restoration for Anterior Diastema Closure

Procedure

Non-invasive direct anterior diastema closure was performed using direct composite resin restorations following standard adhesive procedures.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 18, 2026
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.