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

18 mei 2026 bijgewerkt door: Reem Abdel-Hafez, King Abdullah University Hospital

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

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

7

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Jordanië
    • Jordan
      • Irbid, Jordan, Jordanië, 22110
        • Jordan University of Science and Technology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Test: V-Reverse Suture
Coronally advanced tunnel with V-reverse suture.
Procedure: coronally advanced tunnel with v-reverse suture

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
Actieve vergelijker: Control: Anchored Sling Suture
Coronally advanced tunnel with anchored sling suture
Procedure: coronally advanced tunnel with anchored sling 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
mean root coverage percentage
Tijdsspanne: 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.
3 months
root coverage esthetic score
Tijdsspanne: 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).
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of complete root coverage
Tijdsspanne: 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
3 months
change in keratinized tissue width
Tijdsspanne: at baseline and 3 months
Measured as the distance from gingival margin to mucogingival junction (MGJ) using a periodontal probe (UNC15).
at baseline and 3 months
change in gingival thickness
Tijdsspanne: 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).
at baseline and at 3 months
change in recession depth
Tijdsspanne: at baseline, 1 month, and 3 months
Measured as the distance between the cementoenamel junction (CEJ) and gingival margin using a periodontal probe (UNC15).
at baseline, 1 month, and 3 months
Patient reported experience measures (PREMs)
Tijdsspanne: 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.
For 14 days after surgery
change in probing depth
Tijdsspanne: at baseline and 3 months
Measured as the distance from the gingival margin to the base of the pocket using a periodontal probe (UNC15).
at baseline and 3 months
Patient satisfaction score
Tijdsspanne: 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.
day one, 1week, 2weeks, 1 month, 3months after surgery
Patient perception of pain score
Tijdsspanne: 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.
day one, 1 week, 2 weeks following surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

King Abdullah University Hospital

Medewerkers

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

Onderzoekers

  • Studie stoel: Reem Abdel-Hafez, Jordan University of Science and Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2025

Primaire voltooiing (Werkelijk)

23 maart 2026

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

3 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20240614

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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