Gingival Phenotype and Dental Crowding in Children
Official title: Gingival Phenotype and Dental Crowding in Pediatric Patients, a Pilot Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07205172 · Data updated 2026-11-12
This study looks at how the thickness and other features of gums in kids relate to how their teeth crowd and how the gums might react to moving teeth with braces.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 16 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | October 2026 |
| Study ends | April 2027 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT07205172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 5–16 attending pediatric dentistry or orthodontics clinics, with parental consent, representing primary, mixed, or permanent dentition stages.
✕Probably not a fit
Children whose gingival phenotype or crowding does not show associations with periodontal outcomes under study may see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between gingival phenotype and dental crowding in pediatric patients. It examines buccal-lingual gingival thickness, keratinized tissue width, and underlying bone morphology to understand how these factors influence periodontal stability during orthodontic movement. The study includes children aged 5 to 16 attending pediatric dentistry or orthodontics clinics and combines orthodontic and periodontal assessments to identify potential preventive strategies. By focusing on the mixed dentition period, the research aims to inform interceptive approaches that may limit mucogingival defects. No interventional hypotheses are stated; the work is exploratory and descriptive in nature.
Why it matters
Potential benefit: If successful, findings could guide early, personalized preventive strategies to reduce gingival recession and other periodontal complications during orthodontic treatment in children.
How similar studies have gone: Similar research in adults suggests gingival phenotype influences treatment response, but pediatric data are limited and this study addresses a novel population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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.
Where it's running
-
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, Italy Recruiting
Study contacts
- Principal investigator: Patrizia Gallenzi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Patrizia Gallenzi
- Email: patrizia.gallenzi@unicatt.it
- Phone: +39 0630156358
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.