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Active, Not Recruiting

NCT Number: NCT07602829

V-Reverse Suture Technique Compared to Traditional Anchored Sling Suture in Treating Multiple Gingival Recession

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, Jordan, 22110

About this study

This split-moth pilot study is designed to assess the comparative effectiveness of V-reverse suturing technique(test) and anchored sling suturing technique (Control) in patients with bilateral multiple adjacent gingival recession. The primary aim of the study is to compare the test and control groups in terms of the obtained mean root coverage (mRC) and Root coverage esthetic score (RES) in 3 months. The secondary aims are to compare the two groups in terms of Complete root coverage (CRC), Keratinized tissue width (KTW), Gingival thickness (GT), Recession depth (REC), Probing depth (PD), and Patient-reported outcomes and satisfaction.

At surgery day (T0) baseline measurements and photographs will be taken for all participants and they will be treated with coronally advanced tunnel with autogenous connective tissue graft harvested from the palate for both sides. Each side will be randomly allocated for either V-reverse suturing technique (test) or anchored sling suturing technique (control) to advance the tunnel coronally. At the end of the surgery postoperative instructions will be delivered to all patients in a written and oral manner, in conjunction with a medical prescription, and post-operative questionnaire to fill for the next 14 days to capture patient-reported experience measures (PREMs).

Participants will be re-evaluated at 1 week and at 2 weeks sutures will be removed.

At (T1) 1 month after surgery the following parameters will be recorded : bleeding on probing (BOP), plaque index (PI), and recession depth.

At (T2) 3 month after surgery the following parameters will be recorded : bleeding on probing (BOP), plaque index (PI), recession depth, probing depth (PD), clinical attachment loss (CAL), gingival thickness (GT), keratinized tissue width (KTW), Root coverage esthetic score (RES), mean root coverage% (mRC%), and complete root coverage(cRC "YES/NO")..

Visual analog scale from 0 - 10 (10- very dissatisfied, 0- very satisfied) at each visit after surgery was taken to assess patients overall satisfaction, and another visual analog scale from 0 - 10 (10- worst pain, 0- no pain) to assess patients perceptions of pain.

Photographs will be taken at each visit, all indices will be recorded by a calibrated examiner, and oral hygiene instructions will be reinforced at each visit.

The trial will be conducted in accordance with the Declaration of Helsinki (2013) and Good Clinical Practice (GCP) guidelines. Approval has been granted by the Institutional Review Board (IRB) of Jordan University of Science and Technology. Written informed consent will be obtained from all participants prior to enrollment. Adverse events will be documented, monitored, and reported according to IRB requirements.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

coronally advanced tunnel with v-reverse suture

Procedure

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

coronally advanced tunnel with anchored sling suture

Procedure

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.

Primary outcomes

  1. mean root coverage percentage

    Time frame: 3 months

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

  2. root coverage esthetic score

    Time frame: 3 months

    (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).

Secondary outcomes

  1. Percentage of complete root coverage

    Time frame: 3 months

    a periodontal surgical outcome where the gingival margin is repositioned to the level of, or coronal to, the cementoenamel junction (CEJ), completely covering previously exposed root surfaces

  2. change in keratinized tissue width

    Time frame: at baseline and 3 months

    Measured as the distance from gingival margin to mucogingival junction (MGJ) using a periodontal probe (UNC15).

  3. change in gingival thickness

    Time frame: at baseline and at 3 months

    Probe visibility technique was used, by inserting a periodontal probe (UNC15) in mid-facial aspect of the tooth, and thin gingival biotype is defined as ≤ 1mm (visible probe), while thick is > 1mm (invisible probe).

  4. change in recession depth

    Time frame: at baseline, 1 month, and 3 months

    Measured as the distance between the cementoenamel junction (CEJ) and gingival margin using a periodontal probe (UNC15).

  5. Patient reported experience measures (PREMs)

    Time frame: For 14 days after surgery

    were assessed using validated translations of the OHIP-14 questionnaire into the native language of all participants. Patients were instructed to use a postoperative diary for the first 14 days after the surgery to capture patient-reported experience measures (PREMs). The diary was designed to assess patient recovery in four main areas: post-surgery sequelae, pain and discomfort, oral function, interference with daily activities.

  6. change in probing depth

    Time frame: at baseline and 3 months

    Measured as the distance from the gingival margin to the base of the pocket using a periodontal probe (UNC15).

  7. Patient satisfaction score

    Time frame: day one, 1week, 2weeks, 1 month, 3months after surgery

    Visual analog scale from 0 - 10 (10- very dissatisfied, 0- very satisfied) at each visit after surgery was taken to assess patients overall satisfaction.

  8. Patient perception of pain score

    Time frame: day one, 1 week, 2 weeks following surgery

    Visual analog scale from 0 - 10 (10- worst pain, 0- no pain) to assess patients perceptions of pain.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Deanship of Scientific Research/Jordan University of Science and Technology
  • Jordan University of Science and Technology

Registry information

Official study title

Modified Coronally Advanced Tunnel for Root Coverage With Sling Suture VS. V-Reverse Suture: A Slit-Mouth Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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