Gingival Phenotype and Dental Crowding in Pediatric Patients

NCT07205172 | Recruiting DMC

• 1 other identifier: 7704
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Crowding, Tooth; Gingival Diseases

Outcome Measures

Primary Outcomes (1)

• Gingival Phenotype in Pediatric Patients Across Dentition Stages

  Assessment of gingival phenotype in pediatric patients categorized by dentition stage: Group 1: Primary dentition Group 2: Early mixed dentition Group 3: Late mixed dentition Group 4: Permanent dentition Gingival phenotype will be classified as thin or thick based on standardized clinical criteria. Measurement Tool: Transgingival probing using a periodontal probe (probe transparency method) Unit of Measure: Categorical variable: Thin vs. Thick gingival phenotype Gingival thickness measured in millimeters (mm), if quantitative assessment is used.

  24 months (18 months data collection, 12 months data processing and analysis)

Secondary Outcomes (1)

• Comparison of Crowding Indices and Periodontal Biotype

  From ethics committee approval through 24 months (18 months data collection, 12 months data processing and analysis)

Study Arms (4)

Pediatric patients in the primary dentition stage

This group includes children who still have all their primary (baby) teeth, with no eruption of permanent teeth. Typically, this stage ranges from approximately 2 to 6 years of age.

Other: Orthodontic and periodontal analysis

Pediatric patients in the early mixed dentition stage

This group includes children in the initial phase of tooth transition, where the first permanent molars and incisors have erupted while primary teeth are still present. This stage generally occurs between 6 and 8 years of age.

Other: Orthodontic and periodontal analysis

Pediatric patients in the late mixed dentition stage

This group consists of children in the later phase of dental transition, when canines and premolars begin to replace primary teeth. It usually occurs between 9 and 12 years of age.

Other: Orthodontic and periodontal analysis

Pediatric patients in the permanent dentition stage

This group includes adolescents who have completed the transition and have all or nearly all of their permanent teeth, excluding third molars (wisdom teeth). This stage typically begins around age 12 and up.

Other: Orthodontic and periodontal analysis

Interventions

Orthodontic and periodontal analysis OTHER

Intraoral digital impression aimed at orthodontic analysis and periodontal evaluation using a dedicated periodontal probe, as part of the routine dental examination.

Pediatric patients in the early mixed dentition stage; Pediatric patients in the late mixed dentition stage; Pediatric patients in the permanent dentition stage; Pediatric patients in the primary dentition stage

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population of both sexes, aged between 5 and 16 years.

You may qualify if:

• 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 ≤
• ). 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Malocclusion; Gingival Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Patrizia Gallenzi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Gallenzi

CONTACT

+39 0630156358; patrizia.gallenzi@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)