Crowding, ToothBIOTIPO_PEDONCT07205172
Gingival Phenotype and Dental Crowding in Pediatric Patients
An observational study of Crowding, Tooth and Gingival Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The periodontal phenotype influences treatment outcomes across dental specialties, as tissues of different thickness respond differently to chemical, bacterial, and mechanical insults. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding, Tooth, Gingival Diseases
- What is being tested?
- Orthodontic and periodontal analysis
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric population of both sexes, aged between 5 and 16 years.
Who may be able to join
- 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).
Who cannot join
- 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.
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- Tooth-related:
- Presence of dental agenesis or dental anomalies.
- Dental sites with mucogingival problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, 00168
Prof. Patrizia Gallenzi, +39 0630156358, patrizia.gallenzi@unicatt.it
About this study
Official title: Gingival Phenotype and Dental Crowding in Pediatric Patients, a Pilot Study
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.
Read more
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.
Read the detailed description
Background and Rationale
The periodontal phenotype-defined by the bucco-lingual thickness of the gingiva, the width of keratinized tissue, and the underlying bone morphology-plays a central role in the response of periodontal tissues to orthodontic forces, bacterial insults, and restorative or surgical procedures. Thin-scalloped phenotypes are associated with a higher risk of gingival recession, dehiscence, and fenestration, especially when teeth are moved beyond their bony envelope.
During the mixed dentition phase, significant changes occur in both soft and hard tissues as part of the normal development of the stomatognathic system. These changes may affect tooth position and the stability of periodontal tissues, making evaluation of the gingival phenotype particularly relevant in pediatric patients. Mandibular incisors have been identified as the most vulnerable teeth for the development of labial gingival recession following orthodontic treatment.
Interceptive orthodontics aims to prevent or limit the severity of malocclusions at an early age. Early identification of a thin gingival phenotype enables clinicians to consider preventive measures-such as restricting tooth movement within biological limits or planning soft tissue augmentation procedures prior to critical orthodontic movements.
Genetic, anatomical, and functional factors influence the gingival response to orthodontic forces; therefore, personalized orthodontic planning that integrates periodontal assessment is essential for long-term treatment outcomes and periodontal health.
Gap in the Literature
No studies currently available in the literature have evaluated the relationship between the severity of dental crowding and the periodontal phenotype in pediatric patients. Data in the adult population remain inconsistent: Kaya et al. found no correlation between gingival phenotype and skeletal malocclusion in adults, while Kong et al. reported an association between a thin biotype and skeletal Class I and III, specifically at the left mandibular central incisor, as well as a significant association between thin phenotype and normodivergent and hypodivergent patterns. No predictive model currently exists for identifying patients at periodontal risk due to severe crowding in childhood.
Study Objectives
Primary objective: To assess the periodontal phenotype in pediatric patients at different stages of dental transition (early, middle, and late mixed dentition) and to investigate the association between a thin periodontal biotype and severe dental crowding.
Secondary objectives: To evaluate the distribution of periodontal phenotype subtypes across different stages of dental development; to identify potential clinical predictors of a thin phenotype in the pediatric population; and to provide preliminary data for future longitudinal studies on periodontal outcomes in patients undergoing interceptive orthodontic treatment.
Study Design
This is a cross-sectional, observational study conducted in pediatric patients presenting for routine dental examination. Periodontal phenotype will be assessed using validated clinical and/or ultrasound-based methods. Dental crowding will be classified according to standard indices. Data on dental development stage, skeletal pattern, and relevant clinical variables will be collected. Statistical analyses will include descriptive statistics and appropriate tests of association.
- Conditions
- Crowding, Tooth, Gingival Diseases
- Being tested
- Orthodontic and periodontal analysis
- Medical subject headings
- Malocclusion, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic and periodontal analysisOther
Intraoral digital impression aimed at orthodontic analysis and periodontal evaluation using a dedicated periodontal probe, as part of the routine dental examination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Orthodontic and periodontal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: From ethics committee approval through 24 months (18 months data collection, 12 months data processing and analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start16 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding, ToothStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizia Gallenzi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205172
- Sponsor's protocol ID
- 7704
- Acronym
- BIOTIPO_PEDO
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Phenotype and Dental Crowding in Pediatric Patients, a Pilot Study
- ClinicalTrials.gov ID
- NCT07205172
- Acronym / sponsor ID
- BIOTIPO_PEDO / 7704
- Conditions
- Crowding, Tooth, Gingival Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
The periodontal phenotype-defined by the bucco-lingual thickness of the gingiva, the width of keratinized tissue, and the underlying bone morphology-plays a central role in the response of periodontal tissues to orthodontic forces, bacterial insults, and restorative or surgical procedures. Thin-scalloped phenotypes are associated with a higher risk of gingival recession, dehiscence, and fenestration, especially when teeth are moved beyond their bony envelope.
During the mixed dentition phase, significant changes occur in both soft and hard tissues as part of the normal development of the stomatognathic system. These changes may affect tooth position and the stability of periodontal tissues, making evaluation of the gingival phenotype particularly relevant in pediatric patients. Mandibular incisors have been identified as the most vulnerable teeth for the development of labial gingival recession following orthodontic treatment.
Interceptive orthodontics aims to prevent or limit the severity of malocclusions at an early age. Early identification of a thin gingival phenotype enables clinicians to consider preventive measures-such as restricting tooth movement within biological limits or planning soft tissue augmentation procedures prior to critical orthodontic movements.
Genetic, anatomical, and functional factors influence the gingival response to orthodontic forces; therefore, personalized orthodontic planning that integrates periodontal assessment is essential for long-term treatment outcomes and periodontal health.
Gap in the Literature
No studies currently available in the literature have evaluated the relationship between the severity of dental crowding and the periodontal phenotype in pediatric patients. Data in the adult population remain inconsistent: Kaya et al. found no correlation between gingival phenotype and skeletal malocclusion in adults, while Kong et al. reported an association between a thin biotype and skeletal Class I and III, specifically at the left mandibular central incisor, as well as a significant association between thin phenotype and normodivergent and hypodivergent patterns. No predictive model currently exists for identifying patients at periodontal risk due to severe crowding in childhood.
Study Objectives
Primary objective: To assess the periodontal phenotype in pediatric patients at different stages of dental transition (early, middle, and late mixed dentition) and to investigate the association between a thin periodontal biotype and severe dental crowding.
Secondary objectives: To evaluate the distribution of periodontal phenotype subtypes across different stages of dental development; to identify potential clinical predictors of a thin phenotype in the pediatric population; and to provide preliminary data for future longitudinal studies on periodontal outcomes in patients undergoing interceptive orthodontic treatment.
Study Design
This is a cross-sectional, observational study conducted in pediatric patients presenting for routine dental examination. Periodontal phenotype will be assessed using validated clinical and/or ultrasound-based methods. Dental crowding will be classified according to standard indices. Data on dental development stage, skeletal pattern, and relevant clinical variables will be collected. Statistical analyses will include descriptive statistics and appropriate tests of association.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients in the primary dentition stage | – | Other: Orthodontic and periodontal analysisThis 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. |
| Pediatric patients in the early mixed dentition stage | – | Other: Orthodontic and periodontal analysisThis 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. |
| Pediatric patients in the late mixed dentition stage | – | Other: Orthodontic and periodontal analysisThis 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. |
| Pediatric patients in the permanent dentition stage | – | Other: Orthodontic and periodontal analysisThis 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric population of both sexes, aged between 5 and 16 years.
Key inclusion criteria (6 listed)
- 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 ≤
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthodontic and periodontal analysisIntraoral digital impression aimed at orthodontic analysis and periodontal evaluation using a dedicated periodontal probe, as part of the routine dental examination. | Other | 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 |
Primary outcome
Gingival Phenotype in Pediatric Patients Across Dentition Stages
Time frame: 24 months (18 months data collection, 12 months data processing and analysis)
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.
1 secondary outcome
Comparison of Crowding Indices and Periodontal Biotype
Time frame: From ethics committee approval through 24 months (18 months data collection, 12 months data processing and analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
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Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia Gallenzi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crowding, Tooth and Gingival Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Gallenzi (+39 0630156358, patrizia.gallenzi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Phenotype in Pediatric Patients Across Dentition Stages (time frame: 24 months (18 months data collection, 12 months data processing and analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.