NCT07205172 Gingival Phenotype and Dental Crowding in Pediatric Patients
| NCT ID | NCT07205172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Crowding, Tooth |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2025-12-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The periodontal phenotype influences treatment outcomes across dental specialties, as tissues of different thickness respond differently to chemical, bacterial, and mechanical insults. In pediatric patients, understanding the gingival phenotype is particularly relevant: a thin phenotype may predispose to dehiscence, fenestration, and gingival recession-especially at the mandibular incisors-when tooth movement exceeds the biological limits of the bony housing. During the mixed dentition phase, significant changes in soft and hard tissues affect tooth position and periodontal stability, making early phenotype assessment essential. Interceptive orthodontics can reduce the long-term risk of mucogingival defects; early identification of a thin biotype allows for preventive strategies, including soft tissue grafting before critical orthodontic movements. No studies have examined the association between dental crowding severity and periodontal phenotype in children. Adult data remain inconsistent: Kaya et al. found no correlation between phenotype and skeletal malocclusion, while Kong et al. reported a site-specific association between thin biotype and skeletal Class I/III at the mandibular central incisor. No predictive model exists for periodontal risk related to severe crowding in childhood. This study aims to assess the periodontal phenotype in pediatric patients across different stages of dental transition and to investigate a possible association between a thin periodontal biotype and severe dental crowding.
Eligibility 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.
Contact & Investigator
Patrizia Gallenzi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07205172 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 16 Years, studying Crowding, Tooth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07205172 currently recruiting?
Yes, NCT07205172 is actively recruiting participants. Contact the research team at patrizia.gallenzi@unicatt.it for enrollment information.
Where is the NCT07205172 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07205172 clinical trial?
NCT07205172 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Patrizia Gallenzi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 180 participants.