Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

18. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

7

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Test: V-Reverse Suture
Coronally advanced tunnel with V-reverse suture.
Fremgangsmåte: 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
Aktiv komparator: Control: Anchored Sling Suture
Coronally advanced tunnel with anchored sling suture
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
mean root coverage percentage
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of complete root coverage
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

King Abdullah University Hospital

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2025

Primær fullføring (Faktiske)

23. mars 2026

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

3. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20240614

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Gingival resesjon, mukogingival kirurgi

Kliniske studier på coronally advanced tunnel with v-reverse suture

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Algeria

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere