Maxillary Anterior DiastemaNCT07480551
Effect of Direct Anterior Diastema Closure on Quality of Life and Dental Anxiety
A study testing Direct Composite Resin Restoration for Anterior Diastema Closure in people with Maxillary Anterior Diastema, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Anterior Diastema
- What is being tested?
- Direct Composite Resin Restoration for Anterior Diastema Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of cognitive or psychiatric disorders
- History of substance abuse
- Presence of malignant diseases
- Presence of acute dental or periodontal conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, 53020
About this study
Official title: 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.
- Conditions
- Maxillary Anterior Diastema
- Being tested
- Direct Composite Resin Restoration for Anterior Diastema Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Composite Resin Restoration for Anterior Diastema ClosureProcedure or surgery
Non-invasive direct anterior diastema closure was performed using direct composite resin restorations following standard adhesive procedures.
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior Diastema Closure | Experimental | Participants with maxillary anterior diastema received non-invasive direct anterior diastema closure using direct composite resin restorations. Receives: Procedure: Direct Composite Resin Restoration for Anterior Diastema Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Health-Related Quality of Life (OHIP-14 Score)
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.
Measured: Baseline and 3 months after treatment
Change in Dental Anxiety (MDAS Score)
Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 to 25, with higher scores indicating greater dental anxiety.
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start28 Mar 2025
- Primary completion1 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Anterior DiastemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih bedir, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480551
- Sponsor's protocol ID
- Recep Tayyip Erdogan Universit
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Direct Anterior Diastema Closure Treatment on Oral Health-related Quality of Life and Dental Anxiety
- ClinicalTrials.gov ID
- NCT07480551
- Acronym / sponsor ID
- Recep Tayyip Erdogan Universit
- Conditions
- Maxillary Anterior Diastema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Diastema Closure | Experimental | Procedure: Direct Composite Resin Restoration for Anterior Diastema ClosureParticipants with maxillary anterior diastema received non-invasive direct anterior diastema closure using direct composite resin restorations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of cognitive or psychiatric disorders
- History of substance abuse
- Presence of malignant diseases
- Presence of acute dental or periodontal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Composite Resin Restoration for Anterior Diastema ClosureNon-invasive direct anterior diastema closure was performed using direct composite resin restorations following standard adhesive procedures. | Procedure or surgery | Direct Anterior Diastema Closure |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Composite Resin Restoration for Anterior Diastema Closure in people with Maxillary Anterior Diastema, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Health-Related Quality of Life (OHIP-14 Score) (time frame: Baseline and 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.