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NCT Number: NCT07309653

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

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?

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Key information

Conditions

Tooth Injuries Behavior Dental Restoration, Permanent Health Behavior Patient Satisfaction Stomatognathic Diseases Tooth Diseases Treatment Adherence and Compliance Wounds and Injuries

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University

Bangkok, Thailand

Location status: Recruiting

Location contact

Sawanya Prutthithaworn, Dr

CONTACT

[email protected]

+662-200-7821

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 1-week, 6-month, 12-month after restoration

    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).

  2. Parent satisfaction

    Time frame: 1-week, 6-month, 12-month after restoration

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sawanya Prutthithaworn Dr, PhD

CONTACT

[email protected]

+662-200-7821

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Jan 2, 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.

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