Gingival Recession, LocalizedNCT06553677
Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession
A study testing Tunneled coronal advanced flap with connective tissue graft and Coronally advanced flap with connective tissue graft in people with Gingival Recession, Localized, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites. 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, Localized
- What is being tested?
- Tunneled coronal advanced flap with connective tissue graft and Coronally advanced flap with connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 18 years or older.
- Isolated recession defect classified as RT2.
- Patients with healthy systemic condition.
- Clinical indication and/or patient request for root coverage.
- O'Leary index less than 20%.
Who cannot join
- Pregnant females
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.
Read the detailed description
Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini \& Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli \& Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.
(Barootchi \& Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.
So, this clinical trial aims to address this gap of the literature.
- Conditions
- Gingival Recession, Localized
- Being tested
- Tunneled coronal advanced flap with connective tissue graft, Coronally advanced flap with connective tissue graft
- Keywords
- TCAF, CAF, RT2, Gingival recession depth reduction
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneled coronal advanced flap with connective tissue graftProcedure or surgery
Tunneled coronal advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites.
Coronally advanced flap with connective tissue graftProcedure or surgery
Coronally advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites
| Study group | Role | What they receive |
|---|---|---|
| Tunneled coronal advanced flap with connective tissue graft | Experimental | TCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement.
The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner.
. The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. .
The harvested connective tissue graft will be inserted underneath the flap Receives: Procedure: Tunneled coronal advanced flap with connective tissue graft |
| Coronally advanced flap with connective tissue graft | Active comparator | A trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction:
* The surgical papillae will be elevated by split thickness keeping the blade almost parallel to the root.
* The soft tissue apical to the root exposure will be elevated in a full thickness manner to expose 3-4mm of bone apical to the bone dehiscence. This was done to include the periosteum in the thickness of that central portion of the flap covering the avascular root exposure.
* The releasing vertical incisions will be elevated by split thickness keeping the blade parallel to the bone thus leaving the periosteum to protect the underlying bone in the lateral areas of the flap.
* The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction.
The harvested connective tissue graft will be inserted underneath the flap 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.
Gingival Recession Depth
It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.
Measured: 6 months
Secondary outcomes (11)
Percentage of mean root coverage (MRC%)
(Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 [%]
Measured: 6 months
Percentage of complete root coverage (CRC%)
Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 [%]
Measured: 6 months
Gingival Recession Width
Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth)
Measured: 6 months
Gingival Thickness
Measured using transgingival needle probing using anesthesic needle a rubber stopper
Measured: 6 months
Keratinized Tissue Width
Measured as the distance between the gingival margin and the mucogingival junction (MGJ).
Measured: 6 months
Clinical Attachment Level
Measured from the CEJ to the bottom of the gingival sulcus.
Measured: 6 months
Probing Pocket Depth
Measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 6 months
Pink Esthetic Score
It's a score by (Fürhauser et al., 2005) based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture.
Each variable is assessed with a 0-1-2 score, with 2 being the best and 0 being the poorest score.
Measured: 6 months
Post-operative pain
Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.
Measured: 2 weeks
Post-operative patient satisfaction
A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed.
Measured: 2 weeks, 6 months
Root coverage esthetic score
(Cairo et al., 2009) This score evaluates five variables: level of the gingival margin (GM) , marginal tissue contour (MTC), soft tissue texture (STT) , mucogingival junction (MGJ) alignment , and gingival color (GC).
- GM: Zero point for failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points partial root coverage; 6 points CRC.
- MTC: Zero point irregular gingival margin (does not follow the CEJ); 1 point -proper marginal contour/ scalloped gingival margin (follows the CEJ).
- STT: Zero point for scar formation and/or keloid-like appearance; I point absence of scar or keloid formation.
- MGJ: Zero point -MGJ not aligned with the MGJ of adjacent teeth; 1 point if the MGJ aligned with the MGJ of adjacent teeth.
- GC: Zero point color of tissue varies from gingival color at adjacent teeth; 1 point normal color and integration with the adjacent soft tissues. 10 is the ideal esthetic score
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 posted14 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hazem Mohamed Said Sallam, Cairo University
- Investigators
- Engy Ahmed, PhD, Study chair, Cairo UniversityOmar A Ashour, PhD, Study chair, Cairo UniversityYehia H Amer, PhD, Study chair, Cairo UniversityOmar H Sallam, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553677
- Sponsor's protocol ID
- Perio2804
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will check with my study chair.
Publications
Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
PubMed 35175005
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06553677
- Acronym / sponsor ID
- Perio2804
- Conditions
- Gingival Recession, Localized
- Keywords
- TCAF, CAF, RT2, Gingival recession depth reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.
Detailed description
Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini \& Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli \& Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.
(Barootchi \& Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.
So, this clinical trial aims to address this gap of the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It's randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tunneled coronal advanced flap with connective tissue graft | Experimental | Procedure: Tunneled coronal advanced flap with connective tissue graftTCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement. The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner. . The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. . The harvested connective tissue graft will be inserted underneath the flap |
| Coronally advanced flap with connective tissue graft | Active comparator | Procedure: Coronally advanced flap with connective tissue graftA trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction: * The surgical papillae will be elevated by split thickness keeping the blade almost parallel to the root. * The soft tissue apical to the root exposure will be elevated in a full thickness manner to expose 3-4mm of bone apical to the bone dehiscence. This was done to include the periosteum in the thickness of that central portion of the flap covering the avascular root exposure. * The releasing vertical incisions will be elevated by split thickness keeping the blade parallel to the bone thus leaving the periosteum to protect the underlying bone in the lateral areas of the flap. * The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction. The harvested connective tissue graft will be inserted underneath the flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients age 18 years or older.
- Isolated recession defect classified as RT2.
- Patients with healthy systemic condition.
- Clinical indication and/or patient request for root coverage.
- O'Leary index less than 20%.
Key exclusion criteria (4 listed)
- Pregnant females
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
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 |
|---|---|---|
| Tunneled coronal advanced flap with connective tissue graftTunneled coronal advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites. | Procedure or surgery | Tunneled coronal advanced flap with connective tissue graft |
| Coronally advanced flap with connective tissue graftCoronally advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites | Procedure or surgery | Coronally advanced flap with connective tissue graft |
Primary outcome
Gingival Recession Depth
Time frame: 6 months
It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.
11 secondary outcomes
Percentage of mean root coverage (MRC%)
Time frame: 6 months
Percentage of complete root coverage (CRC%)
Time frame: 6 months
Gingival Recession Width
Time frame: 6 months
Gingival Thickness
Time frame: 6 months
Keratinized Tissue Width
Time frame: 6 months
Clinical Attachment Level
Time frame: 6 months
Probing Pocket Depth
Time frame: 6 months
Pink Esthetic Score
Time frame: 6 months
Post-operative pain
Time frame: 2 weeks
Post-operative patient satisfaction
Time frame: 2 weeks, 6 months
Root coverage esthetic score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Results publication: PubMed 35175005Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
- Individual participant dataSharing planned: No. I will check with my study chair.
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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.
Engy Ahmed, PhD study chair
Cairo University
Omar A Ashour, PhD study chair
Cairo University
Yehia H Amer, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunneled coronal advanced flap with connective tissue graft and Coronally advanced flap with connective tissue graft in people with Gingival Recession, Localized, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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 14 Aug 2024. 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 Egypt. 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 Omar H Sallam, MSc (+201113203236, omar.sallam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Recession Depth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553677, which also lists 1 linked publication.
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 14 Aug 2024.