Gingival Phenotype and Dental Crowding in Pediatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-16
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Orthodontic and periodontal analysis

    Other intervention

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

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: Pediatric patients in the primary dentition stage1 intervention
Group B: Pediatric patients in the early mixed dentition stage1 intervention
Group C: Pediatric patients in the late mixed dentition stage1 intervention
Group D: Pediatric patients in the permanent dentition stage1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Comparison of Crowding Indices and Periodontal Biotype

Quantitative assessment of dental crowding in pediatric patients across the four dentition groups. Measurement Tool: Little's Irregularity Index and/or arch length-tooth size discrepancy measured on digital models Unit of Measure: Millimeters (mm) of crowding or Index score (numeric value, continuous)

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

Other outcomes

Sponsors and contacts

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