Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth

NCT ID: NCT07309653

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-16

Study Completion Date

2027-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to evaluate the clinical performance of a single-shade composite resin, used with an injection moulding technique, in restoring maxillary incisors affected by traumatic dental injury in patients aged 6-15 years.

The main questions it aims to answer are:

* How well does a single composite resin colour match the natural tooth?
* How stable is the colour over a 6- and 12-month follow-up?
* How satisfied are the children and parents with the restoration?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Injuries Dental Restoration, Permanent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test

Restoring with an injectable single shade composite resin using an injectable moulding technique

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children who exhibit cooperative dental behaviours (rating 3 and 4) according to Frankl's behaviour rating scale (Frankl et al. 1962)
* Presence of at least one maxillary anterior permanent tooth with one-third of crown structure loss from dental trauma
* The affected tooth must be vital or have undergone vital pulp therapy (e.g., pulpotomy with Calcium hydroxide, white-MTA, or Biodentine)

Exclusion Criteria

* Known allergy to methacrylate-based materials
* Presence of parafunctional habits, such as bruxism
* Presence of rampant caries
* Presence of signs of hypomineralisation, such as post-eruptive breakdown, hypersensitivity, changes in enamel texture and hardness, and abnormal translucency on radiographs.
* The affected tooth is classified as having moderate or severe discolouration according to Dean's fluorosis index (Dean, 1942)
* The affected tooth has lost less than one-third of its coronal crown structure
* The affected tooth has a fracture located at the subgingival margin
* The affected tooth requires splinting due to the severity of the trauma
* Presence of severe malocclusion that could compromise the integrity of the restoration
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sawanya Prutthithaworn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pipop Saikaew, PhD

Role: STUDY_DIRECTOR

Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sawanya Prutthithaworn Dr, PhD

Role: CONTACT

+662-200-7821

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sawanya Prutthithaworn, Dr

Role: primary

+662-200-7821

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MU-DT/PY-IRB 2025/082.3010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.