Gingival Recession, LocalizedNCT06940050
Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.
A study testing Coronally advanced flap with a connective tissue graft and Tunneled coronally advanced flap with a connective tissue graft in people with Gingival Recession, Localized and Gingival Recession, Plastic Surgery, 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 rather recent developed surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions
- What is being tested?
- Coronally advanced flap with a 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
- 30 Apr 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 old
- good oral hygiene
- presence of at least 2 recessions in the premandible
- good general health
Who cannot join
- smoker
- pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays 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 Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.
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 rather recent developed surgical approach.
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. 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, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions, Gingival Recession, Mucogingival Surgery
- Being tested
- Coronally advanced flap with a connective tissue graft, Tunneled coronally advanced flap with a connective tissue graft
- Keywords
- TCAF, tunneled coronally advanced flap, CAF, coronally advanced flap, multiple adjacent gingival recessions, MAGR, premandible
- 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 a connective tissue graftProcedure or surgery
Also called CAF + CTG
The gum at the recession site is detached and reattached 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 reattached 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 a 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 root surface that becomes covered by gingival tissue following a root coverage procedure.
Measured: From enrollment till 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 till ten years after surgical treatment.
pocket depth
The distance from the gingival margin to the bottom of the sulcus measured using a periodontal probe.
Measured: From enrollment till ten years after surgical treatment.
recession reduction
The decrease in the amount of exposed root surface after the root coverage procedure.
Measured: From enrollment till 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 with a periodontal probe.
Measured: From enrollment till ten years after surgical treatment.
gingival thickness
Thickness of the gingival tissue measured 1-2 mm apical to the gingival margin.
Measured: From enrollment till ten years after surgical treatment.
phenotype
thin, thick or combined
Measured: From enrollment till ten years after surgical treatment.
treatment time
Time in minutes from the first incision till the last suture.
Measured: Only measured during surgery in minutes.
post-operative pain at 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 till three months post-operative.
post-operative pain at lower front
Post-operative pain at lower front 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 till 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 till two weeks post-operative.
score of aesthetic result
Aesthetic satisfaction based on root coverage and color match.
Measured: From six months post-operative till ten years post-operative.
root sensitivity
Root sensitivity is assessed using 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 till 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 using 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 till 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 posted23 Apr 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2036 (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, LocalizedStudies 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
- Collaborators
- Mediplus Ltd UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940050
- Sponsor's protocol ID
- ONZ-2024-0498
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.
- ClinicalTrials.gov ID
- NCT06940050
- Acronym / sponsor ID
- ONZ-2024-0498
- Conditions
- Gingival Recession, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions, Gingival Recession, Mucogingival Surgery
- Keywords
- TCAF, tunneled coronally advanced flap, CAF, coronally advanced flap, multiple adjacent gingival recessions, MAGR, premandible
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Mediplus Ltd UK
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 23 Apr 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 rather recent developed surgical approach.
This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. 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 a 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 old
- good oral hygiene
- presence of at least 2 recessions in the premandible
- good general health
Key exclusion criteria (2 listed)
- smoker
- pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays 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 a connective tissue graftAlso: CAF + CTGThe gum at the recession site is detached and reattached 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 reattached higher (combined with a connective tissue graft). | Procedure or surgery | TCAF + CTG |
Primary outcome
mean root coverage
Time frame: From enrollment till ten years after surgical treatment.
The average percentage of previously exposed tooth root surface that becomes covered by gingival tissue following a root coverage procedure.
13 secondary outcomes
complete root coverage
Time frame: From enrollment till ten years after surgical treatment.
pocket depth
Time frame: From enrollment till ten years after surgical treatment.
recession reduction
Time frame: From enrollment till ten years after surgical treatment.
width of keratinized tissue
Time frame: From enrollment till ten years after surgical treatment.
gingival thickness
Time frame: From enrollment till ten years after surgical treatment.
phenotype
Time frame: From enrollment till ten years after surgical treatment.
treatment time
Time frame: Only measured during surgery in minutes.
post-operative pain at donor site
Time frame: From one week post-operative till three months post-operative.
post-operative pain at lower front
Time frame: From one week post-operative till three months post-operative.
number of analgesics
Time frame: From one week post-operative till two weeks post-operative.
score of aesthetic result
Time frame: From six months post-operative till ten years post-operative.
root sensitivity
Time frame: From one week pre-operative till ten years post-operative.
willingness to retreatment
Time frame: From three months post-operative till 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 1 Oct 2025.
- 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.
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 a connective tissue graft and Tunneled coronally advanced flap with a connective tissue graft in people with Gingival Recession, Localized and Gingival Recession, Plastic Surgery, 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 1 Oct 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 till 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 1 Oct 2025.