NCT07445555

Brief Summary

To identify the predisposing parameters for gingival recessions in adult patients seeking orthodontic treatment. The ultimate aim is to provide a clinical guideline to estimate the risk of developing post-orthodontic gingival recessions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Nov 2023Sep 2027

First Submitted

Initial submission to the registry

October 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

October 13, 2023

Last Update Submit

March 2, 2026

Conditions

Gingival RecessionOrthodontic Treatment

Keywords

gingival recessionorthodontic treatmentgingival phenotypeocclusal factors

Outcome Measures

Primary Outcomes (6)

  • Gingival parameters

    Presence of Recessions (Location and extension): in mm (0 to 9)

    6 months

  • Periodontal phenotype:

    measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)

    6 months

  • Full Mouth Bleeding scores (FMBS)

    In % of total sites (0 to 100)

    6 months

  • Full Mouth Plaque Score (FMPS)

    In % of total sites (0 to 100)

    6 months

  • Occlusion

    Assessed as: N.A, 1 DO, 3/4 DO, 1/2 DO,1/4 DO, NO, 1/4 MO, 1/2 MO, 3/4 MO, 1 MO

    6 months

  • Occlusal contact points

    Measured in mm ( 0.0 to 3.0)

    6 months

Study Arms (4)

Orthodontically treated patient - with recession

Orthodontically treated patient - with recession

Other: Registration of parameters

Orthodontically treated patient - without recession

Orthodontically treated patient - without recession

Orthodontically untreated patient - with recession

Orthodontically untreated patient - with recession

Other: Registration of parameters

Orthodontically untreated patient - without recession

Orthodontically untreated patient - without recession

Interventions

Registration of parametersOTHER

De gingival and occlusal parameters will be recorded for the 4 different cohort groups

Orthodontically treated patient - with recessionOrthodontically untreated patient - with recession

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients adults with or without previous history of orthodontic treatment with and without gingival recessions

You may qualify if:

  • Patients with or without previous history of orthodontic treatment with and without gingival recessions
  • ≥ 18 years old
  • American Society of Anesthesiologists Classification I or II

You may not qualify if:

  • Patients with history of periodontal disease
  • taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers
  • Patients with prior history of radio or chemotherapy
  • Pregnant or breastfeeding patients
  • Patients with agenesis of one or more lower incisors
  • Patients with history of periodontal disease Patients taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers Patients with prior history of radio or chemotherapy Pregnant or breastfeeding patients Patients with agenesis of one or more lower incisors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Ana Castro

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Castro

CONTACT

+3216332407ana.castro@uzleuven.be

Maria Cadenas

CONTACT

+3216332407maria.cadenas@uzleuven.be

Study Design

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

Study Record Dates

First Submitted

October 13, 2023

First Posted

March 3, 2026

Study Start

November 15, 2023

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)