Gingival RecessionNCT05563428
Free Gingival Graft Versus Connective Tissue Graft
A study testing Free gingival graft and Connective tissue graft in people with Gingival Recession and Gingival Recession, Localized, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
This study wil compare FGG and CTG for recession coverage in the anterior mandibula. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Gingival Recession, Localized
- What is being tested?
- Free gingival graft and Connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA type I and II subjects
- Localized Gingival Recessions
- Recessions Cairo RT I-II-III
- FMPS < 10%
- FMBS< 10%
- <10 cigs/ day
- No contra-indication against oral surgical interventions
- Patient is able to give inform consent
Who cannot join
- Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- ASA type > II
- Current pregnancy or breastfeeding women
- Alcoholism or chronically drug abuse
- Smokers, ≳ 10 cigarettes per day
- Immunocompromised patients
Show all 11Show fewer
- Uncontrolled diabetes
- Untreated periodontitis
- History of previous periodontal surgery (mucogingival or other) on the teeth to be included
- Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
Trial locations and contacts
1 site in 1 country.
Isabelle Laleman, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Gilles Szotek, MsC
About this study
Official title: Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT
This study wil compare FGG and CTG for recession coverage in the anterior mandibula.
- Conditions
- Gingival Recession, Gingival Recession, Localized
- Being tested
- Free gingival graft, Connective tissue graft
- Keywords
- Gingival recession, Free gingival graft, Connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
A free gingival graft will be carried out for recession treatment.
Connective tissue graftProcedure or surgery
The pouch technique with a connective tissue graft will be carried out for recession treatment.
| Study group | Role | What they receive |
|---|---|---|
| Free gingival graft | Active comparator | Free gingival graft will be conducted. Receives: Procedure: Free gingival graft |
| Connective tissue graft | Active comparator | The recession will be treated with the pouch technique using a connective tissue graft. Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital mean root coverage
Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.
Measured: Baseline, 3 months, 6 months and up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Sep 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Laleman, Centre Hospitalier Universitaire de Liege
- Investigators
- Szoted Gilles, MSc, Principal investigator, ULiège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563428
- Sponsor's protocol ID
- 2021-242
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT
- ClinicalTrials.gov ID
- NCT05563428
- Acronym / sponsor ID
- 2021-242
- Conditions
- Gingival Recession, Gingival Recession, Localized
- Keywords
- Gingival recession, Free gingival graft, Connective tissue graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Oct 2022 (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.
This study wil compare FGG and CTG for recession coverage in the anterior mandibula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft | Active comparator | Procedure: Free gingival graftFree gingival graft will be conducted. |
| Connective tissue graft | Active comparator | Procedure: Connective tissue graftThe recession will be treated with the pouch technique using a connective tissue graft. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ASA type I and II subjects
- Localized Gingival Recessions
- Recessions Cairo RT I-II-III
- FMPS < 10%
- FMBS< 10%
Key exclusion criteria (11 listed)
- Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- ASA type > II
- Current pregnancy or breastfeeding women
- Alcoholism or chronically drug abuse
- Smokers, ≳ 10 cigarettes per day
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 |
|---|---|---|
| Free gingival graftA free gingival graft will be carried out for recession treatment. | Procedure or surgery | Free gingival graft |
| Connective tissue graftThe pouch technique with a connective tissue graft will be carried out for recession treatment. | Procedure or surgery | Connective tissue graft |
Primary outcome
Digital mean root coverage
Time frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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. This study is not recruiting at the moment.
Isabelle Laleman, PhD contact
Szoted Gilles, MSc principal investigator
ULiège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft and Connective tissue graft in people with Gingival Recession and Gingival Recession, Localized, run by Centre Hospitalier Universitaire de Liege 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact France Lambert, PhD (+32 4 270 31 05, france.lambert@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital mean root coverage (time frame: Baseline, 3 months, 6 months and up to 10 years after surgery). 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 Oct 2022.