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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession Defects
• Intervention / Treatment: Procedure: Coronally Advanced flap combined with sub-epithelial connective tissue graft; Procedure: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft

Detailed Description

To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai Magdy Abu El Eneen, PHD candidate; Phone Number: 0201123864563; Email: mai.abueleneen@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of dentistry cairo ubiversity
    • Contact: Mai Abu El Eneen, PHD candidate; Phone Number: +201123864563; Email: mai.abueleneen@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.
  • 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coronally Advanced flap combined with sub-epithelial connective tissue graft; The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures	Procedure: Coronally Advanced flap combined with sub-epithelial connective tissue graft; The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Experimental: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft; 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.	Procedure: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mai Magdy Abu El Eneen, PHD candidate, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 30, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: CAF; Root coverage; Recession; SCTG; V-CAF
• Other Study ID Numbers: preliminary decision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No