Status:

NOT_YET_RECRUITING

Gingival Phenotype and Dental Crowding in Pediatric Patients

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Crowding, Tooth

Gingival Diseases

Eligibility:

All Genders

5-16 years

Brief Summary

The diagnostic evaluation of the soft and hard tissues surrounding the tooth is one of the most crucial factors in clinical dental practice. It can influence treatment planning and decision-making in ...

Eligibility Criteria

Inclusion

  • Pediatric patients attending the Pediatric Dentistry and/or Orthodontics clinic (consultation and/or outpatient appointment).
  • Parents and/or legal guardians have signed the informed consent for participation in the study.
  • Age between 5 and 16 years.
  • Clinical dentition criteria by group:
  • Group 1 (Primary Dentition): Presence in the mandibular arch of deciduous teeth from canine to canine. Group 2 (Early Mixed Dentition): Presence in the mandibular arch of at least two permanent mandibular incisors, fully erupted (incisal edge at occlusal level) or partially erupted (≥50% of the crown), with no clinical attachment loss, and healthy gingiva or mild gingivitis (Gingival Index, GI ≤ 1). Group 3 (Late Mixed Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤
  • 1). Group 4 (Permanent Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤ 1).

Exclusion

  • Patient-related:
  • Parents and/or legal guardians have not signed the informed consent.
  • Patients who are not sufficiently cooperative to allow a routine dental examination.
  • Non-cooperative patients, including those with special needs.
  • Children with systemic diseases or undergoing medication that affects gingival tissues.
  • Patients who have already undergone orthodontic treatment or are currently undergoing orthodontic treatment.
  • Tooth-related:
  • Presence of dental agenesis or dental anomalies.
  • Dental sites with mucogingival problems.

Key Trial Info

Start Date :

December 16 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT07205172

Start Date

December 16 2025

End Date

April 1 2027

Last Update

December 22 2025

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