Gingival Recessions in Orthodontically Treated and Untreated Adult Patients

March 2, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

Gingival Recessions in Orthodontically Treated and Untreated Adult Patients: a Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The etiology of gingival recessions is yet to be fully understood and is very likely multifactorial, with the involved parameters not necessarily acting simultaneously or in equal extent. The most common etiologic factor would be dental plaque accumulation followed by traumatic tooth brushing, areas with thin, minimal or no keratinized tissue, smoking, malocclusion, dental trauma and high frenal attachment. The labial aspect of the mandibular incisors and maxillary molars is the most often affected by gingival recessions. These contributing factors identified in literature could be grouped in six main categories: age-related, population-related, site-related, mechanical factors, periodontal condition and iatrogenic factors, like orthodontic treatment.

Although quantifying the influence of each factor is very difficult, the association between gingival recessions and orthodontic treatment as an iatrogenic factor has been repeatedly suggested. Given the increasing amount of adult patients seeking orthodontic treatment, the aim of this study is 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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthodontically treated patient - with recession
Other: Registration of parameters
De gingival and occlusal parameters will be recorded for the 4 different cohort groups
Orthodontically treated patient - without recession
Orthodontically untreated patient - with recession
Other: Registration of parameters
De gingival and occlusal parameters will be recorded for the 4 different cohort groups
Orthodontically untreated patient - without recession

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival parameters
Time Frame: 6 months
Presence of Recessions (Location and extension): in mm (0 to 9)
6 months
Periodontal phenotype:
Time Frame: 6 months
measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)
6 months
Full Mouth Bleeding scores (FMBS)
Time Frame: 6 months
In % of total sites (0 to 100)
6 months
Full Mouth Plaque Score (FMPS)
Time Frame: 6 months
In % of total sites (0 to 100)
6 months
Occlusion
Time Frame: 6 months
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
Time Frame: 6 months
Measured in mm ( 0.0 to 3.0)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Ana Castro, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S67563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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