Gingival Recession DefectsNCT07801677
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
A study testing Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft and Coronally Advanced flap combined with sub-epithelial connective tissue graft in people with Gingival Recession Defects, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingival Recession Defects
- What is being tested?
- Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft and Coronally Advanced flap combined with sub-epithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Nov 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥ 18 years.
- Systemically healthy.
- Non-smokers.
- Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- Presence of identifiable CEJ.
- Absence of non-carious cervical lesions.
Show all 10Show fewer
- Mature permanent tooth in the aesthetic zone.
- At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
- Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
- A minimum of (2 mm KTW).
Who cannot join
- Any systemic disease.
- Pregnancy or lactation.
- Cairo RT3 recession defects.
- Teeth with active orthodontic treatment.
- Previous periodontal surgery in the area.
- Use of any drugs that might lead to gingival enlargement.
- Smoking.
- Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of dentistry cairo ubiversity
Cairo, 11562
Mai Abu El Eneen, PHD candidate, +201123864563, mai.abueleneen@dentistry.cu.edu.eg
About this study
Official title: The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
Read the detailed description
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
- Conditions
- Gingival Recession Defects
- Being tested
- Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft, Coronally Advanced flap combined with sub-epithelial connective tissue graft
- Keywords
- V-CAF, CAF, Recession, Root coverage, SCTG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graftProcedure or surgery
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
Coronally Advanced flap combined with sub-epithelial connective tissue graftProcedure or surgery
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
| Study group | Role | What they receive |
|---|---|---|
| Coronally Advanced flap combined with sub-epithelial connective tissue graft | Active comparator | The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures Receives: Procedure: Coronally Advanced flap combined with sub-epithelial connective tissue graft |
| Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft | Experimental | Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage. Receives: Procedure: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recession depth (mm)
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
Measured: at Baseline and 6 months
Secondary outcomes (13)
Gingival Recession Width (mm)
Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction.
Measured: at baseline and 6 months
Keratinized Tissue Width (mm)
Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique
Measured: at Baseline and 6 months
Keratinized Tissue Height (mm)
Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
Measured: at Baseline and 6 months
Probing Depth (mm)
Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva.
Measured: at Baseline and 6 months
Gingival Thickness (mm)
Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm.
Measured: at Baseline and 6 months
Recession Reduction (mm)
Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe.
Measured: at Baseline and 6 months
Clinical Attachment Level (mm)
Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus.
Measured: at Baseline and 6 months
Complete Root Coverage (%)
Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group.
Measured: at 6 months
Bleeding on Probing (+/-)
Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal. A positive finding for BOP will be recorded when bleeding occurred within 10s.
Measured: at Baseline and 6 months
Plaque Index (scores 0, 1, 2, 3)
Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth.
Scores:
0 : No plaque
1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: at Baseline and 6 months
Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen). A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain.
Measured: Surgical day and days 1, 3, 7, and 14 after surgery
Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit. The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration). A total RES score will be calculated by adding these 5 components
Measured: at 6 months
Mean Percentage of Root Coverage (mRC) %
Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = [(RD₀ - RD6) / RD₀] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment.
Measured: (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession DefectsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Magdy Abu El Eneen, Cairo University
- Investigators
- Mai Magdy Abu El Eneen, PHD candidate, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801677
- Sponsor's protocol ID
- preliminary decision
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07801677
- Acronym / sponsor ID
- preliminary decision
- Conditions
- Gingival Recession Defects
- Keywords
- V-CAF, CAF, Recession, Root coverage, SCTG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Sep 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.
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
Detailed description
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronally Advanced flap combined with sub-epithelial connective tissue graft | Active comparator | Procedure: Coronally Advanced flap combined with sub-epithelial connective tissue graftThe combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures |
| Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft | Experimental | Procedure: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graftVertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Age ≥ 18 years.
Key exclusion criteria (8 listed)
- Any systemic disease.
- Pregnancy or lactation.
- Cairo RT3 recession defects.
- Teeth with active orthodontic treatment.
- Previous periodontal surgery in the area.
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 |
|---|---|---|
| Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graftVertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage. | Procedure or surgery | Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft |
| Coronally Advanced flap combined with sub-epithelial connective tissue graftThe combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures | Procedure or surgery | Coronally Advanced flap combined with sub-epithelial connective tissue graft |
Primary outcome
Change in recession depth (mm)
Time frame: at Baseline and 6 months
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
13 secondary outcomes
Gingival Recession Width (mm)
Time frame: at baseline and 6 months
Keratinized Tissue Width (mm)
Time frame: at Baseline and 6 months
Keratinized Tissue Height (mm)
Time frame: at Baseline and 6 months
Probing Depth (mm)
Time frame: at Baseline and 6 months
Gingival Thickness (mm)
Time frame: at Baseline and 6 months
Recession Reduction (mm)
Time frame: at Baseline and 6 months
Clinical Attachment Level (mm)
Time frame: at Baseline and 6 months
Complete Root Coverage (%)
Time frame: at 6 months
Bleeding on Probing (+/-)
Time frame: at Baseline and 6 months
Plaque Index (scores 0, 1, 2, 3)
Time frame: at Baseline and 6 months
Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
Time frame: Surgical day and days 1, 3, 7, and 14 after surgery
Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
Time frame: at 6 months
Mean Percentage of Root Coverage (mRC) %
Time frame: (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
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 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Gingival Recession Defects
Recruiting
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
Gingival Recessions
Not yet recruiting
Hyaluronic Acid and Polynucleotides With Connective Tissue Graft and Coronally Advanced Flap for RT II Gingival Recession
RT II Gingival Recession
Not yet recruitingPhase 1/2
Adding Effect of Cross-linked Hyaluronic Acid to Microneedling After Coronally Advanced Flap in Isolated RT1 Recession
Single RT1 Gingival Recession With no Loss of Interproximal Attachment
Recruiting
Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent
Postoperative Pain, Mucogingival Defects
Not yet recruiting
Clinical Evaluation Comparing Tunneled Coronally Advanced Flap and Modified Coronally Advanced Tunnel With Connective Tissue Graft for Managing Single Gum Recession
Single Recession Defects (RT2)
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.
Mai Magdy Abu El Eneen, PHD candidate principal investigator
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 Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft and Coronally Advanced flap combined with sub-epithelial connective tissue graft in people with Gingival Recession Defects, 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 10 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Sep 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 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?
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 Mai Magdy Abu El Eneen, PHD candidate (0201123864563, mai.abueleneen@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in recession depth (mm) (time frame: at Baseline and 6 months). 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 Sep 2026.