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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07480551
Enrollment
40
Registered
2026-03-18
Start date
2025-03-28
Completion date
2025-08-31
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Anterior Diastema

Brief summary

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.

Interventions

PROCEDUREDirect Composite Resin Restoration for Anterior Diastema Closure

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

Sponsors

Recep Tayyip Erdogan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Oral Health-Related Quality of Life (OHIP-14 Score)Baseline and 3 months after treatmentOral 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)Baseline and 3 months after treatmentDental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 to 25, with higher scores indicating greater dental anxiety.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026