Gingival Recession Generalized ModerateNCT07158528
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Maxilla.
A study testing coronally advanced flap with connective tissue graft and tunneled coronally advanced flap with a connective tissue graft in people with Gingival Recession Generalized Moderate and Gingival Recession Localized Moderate, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Multiple techniques can be used for recession coverage. The most common techniques are: tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a relatively recently developed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Gingival Recession, Generalized
- What is being tested?
- coronally advanced flap with connective tissue graft and tunneled coronally advanced flap with a connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Aug 2025to 31 Dec 2037
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Good oral hygiene
- Presence of multiple gingival recessions in the maxilla
- Good general health
Who cannot join
- Smoker
- Pregnant women (assessed at each visit; if the patient becomes pregnant during follow-up, radiographs will not be taken)
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
Department of Periodontology and Implantology of Ghent University
Ghent, Oost-Vlaanderen, 9000
Véronique Prof. Dr. Christiaens, +32 332 40 17, vchristi.christiaens@ugent.be
About this study
Official title: An RCT Comparing Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With a Soft Tissue Graft for Multiple Recessions Coverage in the Maxilla.
Multiple techniques can be used for recession coverage. The most common techniques are: tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a relatively recently developed surgical approach.
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums at multiple adjacent teeth in the upper jaw. The main question it aims to answer is:
Read more
- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.
Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.
Participants will:
- Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions
- Attend regular check-ups for up to 10 years after surgery
- Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)
- Conditions
- Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Gingival Recession, Generalized, Gingival Recession, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions
- Being tested
- coronally advanced flap with connective tissue graft, tunneled coronally advanced flap with a connective tissue graft
- Keywords
- TCAF, CAF, tunneled coronally advanced flap, coronally advanced flap, maxilla, multiple recessions, MAGR, multiple adjacent gingival recessions
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronally advanced flap with connective tissue graftProcedure or surgery
Also called CAF + CTG
The gum at the recession site is elevated and repositioned higher, combined with a connective tissue graft.
tunneled coronally advanced flap with a connective tissue graftProcedure or surgery
Also called TCAF + CTG
The gum at the recession site is undermined, only partially detached, and repositioned higher, combined with a connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| TCAF + CTG | Active comparator | Tunneled coronally advanced flap with a connective tissue graft. Receives: Procedure: tunneled coronally advanced flap with a connective tissue graft |
| CAF + CTG | Active comparator | Coronally advanced flap with a connective tissue graft. Receives: Procedure: coronally advanced flap with connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean root coverage
The average percentage of previously exposed tooth surface that becomes covered by gingival tissue following a root coverage procedure.
Measured: From enrollment up to ten years after surgical treatment.
Secondary outcomes (13)
complete root coverage
The percentage of teeth for which the previously exposed root surface is completely covered by gingival tissue following the surgical procedure. These teeth show no visible recession after healing.
Measured: From enrollment up to ten years after surgical treatment.
pocket depth
The distance from the gingival margin to the bottom of the sulcus measured by use of a periodontal probe.
Measured: From enrollment up to ten years after surgical treatment.
recession reduction
The change in the amount of exposed root surface after the root coverage procedure.
Measured: From enrollment up to ten years after surgical treatment.
width of keratinized tissue
The distance from the mucogingival junction to the free gingival margin. It includes free and attached gingival tissue, measured by use of a periodontal probe.
Measured: From enrollment up to ten years after surgical treatment.
gingival thickness
Thickness of the gingival tissue, measured 1-2 mm apical to the gingival margin.
Measured: From enrollment up to ten years after surgical treatment.
phenotype
Gingival phenotype is classified as thin, thick or combined.
Measured: From enrollment up to ten years after surgical treatment.
treatment time
Time in minutes from the first incision up to the last suture.
Measured: Only measured during surgery in minutes.
post-operative pain at the donor site
Post-operative pain at the donor site will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.
Measured: From one week post-operative up to three months post-operative.
post-operative pain at the recession site
Post-operative pain at the recession site will be assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.
Measured: From one week post-operative up to three months post-operative.
number of analgesics
The number of pain medication tablets consumed by the patient to manage post-operative pain.
Measured: From one week post-operative up to two weeks post-operative.
score of the aesthetic outcome
Aesthetic satisfaction will be based on root coverage and color match. Aesthetic satisfaction at the recession site will be assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (aesthetic satisfaction not achieved) to 10 (aesthetic satisfaction fully achieved). A higher score indicates greater satisfaction.
Measured: From six months post-operative up to ten years post-operative.
root sensitivity
Root sensitivity is assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (no sensitivity) to 10 (extreme sensitivity), based on a tactile test with controlled air flow. A higher score indicates that the patient experiences greater sensitivity.
Measured: From one week pre-operative up to ten years post-operative.
willingness to retreatment
A patient's willingness to undergo retreatment based on their previous experience with the procedure. It is assessed by the use of the Visual Analogue Scale ranging from 0 (not willing at all) to 10 (extremely willing). A patient reporting a higher score indicates greater willingness.
Measured: From three months post-operative up to two years post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start18 Aug 2025
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession Generalized ModerateStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158528
- Sponsor's protocol ID
- ONZ-2025-0158
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Comparing Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With a Soft Tissue Graft for Multiple Recessions Coverage in the Maxilla.
- ClinicalTrials.gov ID
- NCT07158528
- Acronym / sponsor ID
- ONZ-2025-0158
- Conditions
- Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Gingival Recession, Generalized, Gingival Recession, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions
- Keywords
- TCAF, CAF, tunneled coronally advanced flap, coronally advanced flap, maxilla, multiple recessions, MAGR, multiple adjacent gingival recessions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 8 Sep 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.
Multiple techniques can be used for recession coverage. The most common techniques are: tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a relatively recently developed surgical approach.
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums at multiple adjacent teeth in the upper jaw. The main question it aims to answer is:
- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.
Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.
Participants will:
- Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions
- Attend regular check-ups for up to 10 years after surgery
- Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCAF + CTG | Active comparator | Procedure: tunneled coronally advanced flap with a connective tissue graftTunneled coronally advanced flap with a connective tissue graft. |
| CAF + CTG | Active comparator | Procedure: coronally advanced flap with connective tissue graftCoronally advanced flap with a connective tissue graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Good oral hygiene
- Presence of multiple gingival recessions in the maxilla
- Good general health
Key exclusion criteria (2 listed)
- Smoker
- Pregnant women (assessed at each visit; if the patient becomes pregnant during follow-up, radiographs will not be taken)
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 |
|---|---|---|
| coronally advanced flap with connective tissue graftAlso: CAF + CTGThe gum at the recession site is elevated and repositioned higher, combined with a connective tissue graft. | Procedure or surgery | CAF + CTG |
| tunneled coronally advanced flap with a connective tissue graftAlso: TCAF + CTGThe gum at the recession site is undermined, only partially detached, and repositioned higher, combined with a connective tissue graft. | Procedure or surgery | TCAF + CTG |
Primary outcome
mean root coverage
Time frame: From enrollment up to ten years after surgical treatment.
The average percentage of previously exposed tooth surface that becomes covered by gingival tissue following a root coverage procedure.
13 secondary outcomes
complete root coverage
Time frame: From enrollment up to ten years after surgical treatment.
pocket depth
Time frame: From enrollment up to ten years after surgical treatment.
recession reduction
Time frame: From enrollment up to ten years after surgical treatment.
width of keratinized tissue
Time frame: From enrollment up to ten years after surgical treatment.
gingival thickness
Time frame: From enrollment up to ten years after surgical treatment.
phenotype
Time frame: From enrollment up to ten years after surgical treatment.
treatment time
Time frame: Only measured during surgery in minutes.
post-operative pain at the donor site
Time frame: From one week post-operative up to three months post-operative.
post-operative pain at the recession site
Time frame: From one week post-operative up to three months post-operative.
number of analgesics
Time frame: From one week post-operative up to two weeks post-operative.
score of the aesthetic outcome
Time frame: From six months post-operative up to ten years post-operative.
root sensitivity
Time frame: From one week pre-operative up to ten years post-operative.
willingness to retreatment
Time frame: From three months post-operative up to two years post-operative.
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 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession Generalized Moderate
Enrolling by invitation
Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity
Gingival Recession, Generalized, Gingival Recession Generalized Moderate
Recruiting
The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Gingival Recessions
Gingival Recession Generalized Moderate
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronally advanced flap with connective tissue graft and tunneled coronally advanced flap with a connective tissue graft in people with Gingival Recession Generalized Moderate and Gingival Recession Localized Moderate, run by University Hospital, Ghent 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 4 inclusion and 2 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 16 Sep 2025. 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 Véronique Prof. Dr. Christiaens (+32 332 40 17, vchristi.christiaens@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean root coverage (time frame: From enrollment up to ten years after surgical treatment.). 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 16 Sep 2025.