NCT07602829

Brief Summary

The goal of this split-mouth pilot study is to study the effect of two different suturing techniques in root coverage using coronally advanced flap tunnel in multiple adjacent recession cases to see which technique will give superior outcomes in term of mean root coverage percentage, and root coverage esthetic score after 3-months. The main questions it aims to answer are:

  • Does a suturing technique gives superior mean root coverage percentage over another?
  • Does a suturing technique gives superior root coverage esthetic score? Researcher will compare between V-reverse suturing technique and anchored sling suture to see which will result in superior mean root coverage percentage, and root coverage esthetic score after 3-months. Participants will:
  • Come in for a first visit to check your gum health, check eligibility and to be provided with scaling and polishing if needed.
  • Come in for surgery and clinical measurements.
  • Participant will be asked to complete post-operative questionnaire for 14 days.
  • Re-evaluated after 1 week and suture removal at 2 weeks.
  • Follow-up after 1 and 3 months.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Jun 2027

Study Start

First participant enrolled

April 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 3, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

plaque indexBleeding On ProbingGingival RecessionMultiple Adjacent Gingival RecessionV-reverse sutureanchored sling suturemean root coverageroot coverage esthetic scorecomplete root coveragekeratinized tissue widthgingival thicknessprobing depthrecession depthroot coveragecoronally advanced tunnelpatient-reported experience measurespilot studysplit-mouthgingivaperiodontium

Outcome Measures

Primary Outcomes (2)

  • mean root coverage percentage

    It represents the average percentage of the initial recession depth that has been successfully covered by new gum tissue over a defined period.

    3 months

  • root coverage esthetic score

    (RES) is a, 10-point, five-variable system developed by Cairo et al. (2009) to objectively evaluate the success of gingival recession treatment. It evaluates root coverage (60% weight, 0-6 points) and four soft tissue parameters: margin contour, tissue texture, junction alignment, and color (40% weight, 1 point each).

    3 months

Secondary Outcomes (8)

  • Percentage of complete root coverage

    3 months

  • change in keratinized tissue width

    at baseline and 3 months

  • change in gingival thickness

    at baseline and at 3 months

  • change in recession depth

    at baseline, 1 month, and 3 months

  • Patient reported experience measures (PREMs)

    For 14 days after surgery

  • +3 more secondary outcomes

Study Arms (2)

Test: V-Reverse Suture

EXPERIMENTAL

Coronally advanced tunnel with V-reverse suture.

Procedure: coronally advanced tunnel with v-reverse suture

Control: Anchored Sling Suture

ACTIVE COMPARATOR

Coronally advanced tunnel with anchored sling suture

Procedure: coronally advanced tunnel with anchored sling suture

Interventions

The V-reverse suturing technique can be a valid technique for improving graft and flap stability in the midfacial region which is likely the most crucial area that should be firm for achieving complete root coverage following the tunnel approach. The V-reverse suture starts in the palatal aspect, passing below the splinted contact point. Then the needle engages the graft and the flap (from inside to outside) ≈3 mm apical to the soft tissue margin in the mid-facial area. Then the needle passes to the palatal side under the contact point. Then the needle turns one round around the splinted composite (without pinching the soft tissue), and then the knot is performed and tightened over the composite. At the end, the sutures form a V-reverse shape

Test: V-Reverse Suture

In addition to interrupted sutures, sling sutures have also regularly been applied as a conventional method of suturing to advance periodontal flaps over exposed root surfaces and connect the papillae to the interdental connective tissues, and composite stops where added to provide better stability.

Control: Anchored Sling Suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Periodontally and systemically healthy;
  • Good plaque control (FMPS \< 20%)
  • Presence of two quadrants exhibiting multiple (2 or more sites) adjacent RT1 or RT2 gingival recession ≥ 2 mm in at least one site.
  • Non-smoker.

You may not qualify if:

  • Smoking
  • Pregnant or lactating women;
  • Untreated periodontitis;
  • Systemic disorders with compromised healing potential;
  • Use of medications (immuno-suppressants, phenytoin, or anything else that might affect soft tissue healing);
  • Undergoing radiotherapy;
  • History of mucogingival surgery.
  • Presence of severe tooth malposition, rotation, or super-eruption.
  • Presence of root caries or inadequate prosthetic restorations;
  • Persistence of uncorrected gingival trauma from toothbrushing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan, 22110, Jordan

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Reem Abdel-Hafez

    Jordan University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is conduct in a split mouth fashion, meaning each patient arch is divided into quadrants, each quadrant is then randomized to either the test or the control group. Therefore, the study is considered a parallel-group (within-subject) design in terms of participant recruitment, because each subject receives two experimental interventions. However, from an intervention and randomization perspective, it is a comparative trial where the mouth is divided into quadrants (e.g., left and right) that are randomly assigned to different suturing techniques.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Periodontology

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 22, 2026

Study Start

April 1, 2025

Primary Completion

March 23, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

We plan to share de-identified individual participant data (IPD) including demographics, primary and secondary outcome measures, and adverse events. Data will be made available beginning 12 months after publication of the primary results, and will be accessible to qualified researchers upon reasonable request, subject to data-sharing agreements and IRB approval.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months after publication of primary results and will remain available for 5 years via a controlled access repository upon request and data use agreement.
Access Criteria
Qualified researchers affiliated with academic institutions, healthcare organizations, or nonprofit research centers will be able to request access to the de-identified individual participant data (IPD) and supporting documents, including the Study Protocol, Statistical Analysis Plan (SAP), and Analytic Code. Requests for access will be reviewed by the study sponsor or data access committee to ensure appropriate use and ethical standards. Approved users will receive access via a secure online data repository, after signing a data use agreement that outlines terms of use, privacy protections, and publication rights.

Locations