Tooth InjuriesNCT07309653
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
An observational study of Tooth Injuries and Dental Restoration, Permanent, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Injuries, Dental Restoration, Permanent
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteThailand
- Study dates
- 16 Dec 2025to 28 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients aged 6-15 years who visit the Pediatric Dental Clinic at the Faculty of Dentistry, Mahidol University, for maxillary anterior tooth restoration
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University
Bangkok
Sawanya Prutthithaworn, Dr, +662-200-7821, sawanya.pru@mahidol.ac.th
About this study
Official title: Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
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?
- Conditions
- Tooth Injuries, Dental Restoration, Permanent
- Keywords
- Patient satisfaction, Color stability, Color matching, Single shade composter resins, Injection moulding technique, Flowable composite resins, Dental trauma
- Medical subject headings
- Tooth Injuries, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test | Restoring with an injectable single shade composite resin using an injectable moulding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colour matching
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Measured: Immediate, 1-week, 6-month, 12-month after restoration
Colour stability
Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.
Measured: 1-week, 6-month, 12-month after restoration
Secondary outcomes (2)
Patient satisfaction
Patients show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
Measured: 1-week, 6-month, 12-month after restoration
Parent satisfaction
Parents show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
Measured: 1-week, 6-month, 12-month after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start16 Dec 2025
- Primary completion29 Oct 2026 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth InjuriesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawanya Prutthithaworn, Mahidol University
- Investigators
- Pipop Saikaew, PhD, Study director, Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309653
- Sponsor's protocol ID
- MU-DT/PY-IRB 2025/082.3010
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07309653
- Acronym / sponsor ID
- MU-DT/PY-IRB 2025/082.3010
- Conditions
- Tooth Injuries, Dental Restoration, Permanent
- Keywords
- Patient satisfaction, Color stability, Color matching, Single shade composter resins, Injection moulding technique, Flowable composite resins, Dental trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 30 Dec 2025 (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 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test | – | –Restoring with an injectable single shade composite resin using an injectable moulding technique |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients aged 6-15 years who visit the Pediatric Dental Clinic at the Faculty of Dentistry, Mahidol University, for maxillary anterior tooth restoration
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colour matching
Time frame: Immediate, 1-week, 6-month, 12-month after restoration
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Colour stability
Time frame: 1-week, 6-month, 12-month after restoration
Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.
2 secondary outcomes
Patient satisfaction
Time frame: 1-week, 6-month, 12-month after restoration
Parent satisfaction
Time frame: 1-week, 6-month, 12-month after restoration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Pipop Saikaew, PhD study director
Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Injuries and Dental Restoration, Permanent, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Jan 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawanya Prutthithaworn Dr, PhD (+662-200-7821, sawanya.pru@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour matching (time frame: Immediate, 1-week, 6-month, 12-month after restoration). 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 2 Jan 2026.