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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Mai Magdy Abu El Eneen, PHD candidate contact

0201123864563

mai.abueleneen@dentistry.cu.edu.eg

Egypt1 site
  • Faculty of dentistry cairo ubiversity

    Cairo, 11562

    Mai Abu El Eneen, PHD candidate, +201123864563, mai.abueleneen@dentistry.cu.edu.eg

Other trials in Egypt

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.

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 groups in NCT07801677
Study groupRoleWhat they receive
Coronally Advanced flap combined with sub-epithelial connective tissue graftActive comparatorThe 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 graftExperimentalVertically 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted3 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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)
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

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.

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