Gingival RecessionNCT07445555
Gingival Recessions in Orthodontically Treated and Untreated Adult Patients
An observational study of Gingival Recession and Orthodontic Treatment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Orthodontic Treatment
- What is being tested?
- Registration of parameters
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2023to 1 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients adults with or without previous history of orthodontic treatment with and without gingival recessions
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Ana Castro, Drs, +32 16 37 37 48, anabelen.castrosarda@kuleuven.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Recession, Orthodontic Treatment
- Being tested
- Registration of parameters
- Keywords
- gingival recession, orthodontic treatment, gingival phenotype, occlusal factors
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of parametersOther
De gingival and occlusal parameters will be recorded for the 4 different cohort groups
| Study group | Role | What they receive |
|---|---|---|
| Orthodontically treated patient - with recession | Orthodontically treated patient - with recession Receives: Other: Registration of parameters | |
| Orthodontically treated patient - without recession | Orthodontically treated patient - without recession | |
| Orthodontically untreated patient - with recession | Orthodontically untreated patient - with recession Receives: Other: Registration of parameters | |
| Orthodontically untreated patient - without recession | Orthodontically untreated patient - without recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival parameters
Presence of Recessions (Location and extension): in mm (0 to 9)
Measured: 6 months
Periodontal phenotype:
measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)
Measured: 6 months
Full Mouth Bleeding scores (FMBS)
In % of total sites (0 to 100)
Measured: 6 months
Full Mouth Plaque Score (FMPS)
In % of total sites (0 to 100)
Measured: 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
Measured: 6 months
Occlusal contact points
Measured in mm ( 0.0 to 3.0)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Nov 2023
- Primary completion15 Jul 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Castro, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445555
- Sponsor's protocol ID
- S67563
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Recessions in Orthodontically Treated and Untreated Adult Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT07445555
- Acronym / sponsor ID
- S67563
- Conditions
- Gingival Recession, Orthodontic Treatment
- Keywords
- gingival recession, orthodontic treatment, gingival phenotype, occlusal factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Mar 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orthodontically treated patient - with recession | – | Other: Registration of parametersOrthodontically treated patient - with recession |
| Orthodontically treated patient - without recession | – | –Orthodontically treated patient - without recession |
| Orthodontically untreated patient - with recession | – | Other: Registration of parametersOrthodontically untreated patient - with recession |
| Orthodontically untreated patient - without recession | – | –Orthodontically untreated patient - without recession |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients adults with or without previous history of orthodontic treatment with and without gingival recessions
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Registration of parametersDe gingival and occlusal parameters will be recorded for the 4 different cohort groups | Other | Orthodontically treated patient - with recession, Orthodontically untreated patient - with recession |
Primary outcome
Gingival parameters
Time frame: 6 months
Presence of Recessions (Location and extension): in mm (0 to 9)
Periodontal phenotype:
Time frame: 6 months
measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)
Full Mouth Bleeding scores (FMBS)
Time frame: 6 months
In % of total sites (0 to 100)
Full Mouth Plaque Score (FMPS)
Time frame: 6 months
In % of total sites (0 to 100)
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
Occlusal contact points
Time frame: 6 months
Measured in mm ( 0.0 to 3.0)
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ana Castro principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Gingival Recession and Orthodontic Treatment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 6 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 3 Mar 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 Belgium. 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 Ana Castro (+3216332407, ana.castro@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival parameters (time frame: 6 months). The study lists 6 primary outcomes in all. 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 3 Mar 2026.