Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study

15 september 2026 bijgewerkt door: Postgraduate Institute of Dental Sciences Rohtak

To evaluate the association between the width of keratinized tissue and attached gingiva with root coverage outcomes in RT1 gingival recession defects of maxillary and mandibular anterior teeth treated with subepithelial connective tissue graft (CTG) using a minimally invasive technique : modified vestibular incision subperiosteal tunnel access(m-VISTA).

OBJECTIVES

  1. PRIMARY OBJECTIVES

    1. To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mRC and gingival margin position with baseline parameters including width of keratinized tissue and width of attached gingiva, after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
    2. To evaluate 3 and 6 months outcomes (percentage of root coverage, width of keratinized tissue and width of attached gingiva), after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
    3. To access the long-term stability of gingival margin achieved from 3 months to 6 months.
  2. SECONDARY OBJECTIVES

    1. To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (bCAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
    2. To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.

Studie Overzicht

Gedetailleerde beschrijving

Recent longitudinal evidence suggests that soft tissue thickness may play a more decisive role in long-term stability than keratinized tissue width (KTW) alone. The baseline keratinized tissue width necessary to achieve stable outcomes remain lacking as the scarcity of cases presenting with minimal or no keratinized tissue width limited the exploration of its influence on achieving complete root coverage in scenarios characterized by extremely reduced or absent keratinized tissue width.

Furthermore, attached gingiva width (AGW) has been insufficiently studied despite its proposed biological relevance in providing functional connective tissue attachment to the underlying hard tissues. In recent randomized controlled trial attached gingiva width was considered along with root coverage percentage as a primary outcome in evaluating collagen matrix (CM) versus connective tissue graft with modified coronally advanced tunnel technique in isolated RT1 cases. A recent study in which anatomical factors affecting root coverage among mandibular incisors were studied and presented limitations such as restricted inclusion of sites, presenting type of recession defects and limited cases with minimal or absent keratinized tissue, thereby limiting its ability to define its absolute indication or minimum requirement for successful root coverage. Collectively, these limitations were particularly related to inclusion of mandibular sites. On perusal of literature revealed there is no prospective study in which baseline keratinized tissue width and attached gingiva width as prognostic factors for root coverage were studied.

Therefore, the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft.

Details of Methodology

  1. Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
  2. Study period- up to 24 months
  3. Study subjects The sample size was calculated using G*Power software to achieve 80% statistical power for detecting a significant correlation of r = 0.5 using a linear regression model based on the previously conducted prospective study. The analysis indicated that 26 patients were required. To compensate for an anticipated 10% dropout rate, the sample size was increased, resulting in a final required sample size of 30 participants.

e. Method of recruitment The study will recruit systematically healthy patients exhibiting Millers class Ⅰ and Ⅱ or RT1 recession defects in maxillary and mandibular anterior teeth from the periodontology outpatient department.

f. Intervention Scaling and root planing Following selection, all the patients will be subjected to phase I therapy, which included full mouth scaling and root planing using ultrasonic scalers and hand instrumentation.

Surgical procedure Connective Tissue Graft Harvesting (Single Incision Technique) After local anesthesia, a single horizontal incision was made 2 mm from the gingival margin of maxillary premolars using a #15 blade (90° to bone). A partial thickness dissection was performed through the same incision to create an undermined area of required size. The connective tissue graft was then outlined with mesial, distal, and medial incisions, separated, and removed using a periosteal elevator. The donor site was closed with horizontal suspension sutures.

m-VISTA Technique : After local anesthesia and root planing, a small vestibular incision was made near the MGJ using a 15C blade. A full-thickness subperiosteal tunnel was created and extended beneath adjacent papillae. An SCTG was inserted through the incision, positioned under the recession area, and the gingivo-papillary complex was coronally advanced and secured with monofilament sutures.

Post operative care Suitable antibiotics and analgesics will be prescribed for 5 days. Chlorhexidine (0.12%) mouthwash for a week. The Coronally attached bonded sutures will be removed after 3 weeks.

Follow up All patients will be recalled for recording of all the clinical parameters at 3and 6 months.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

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.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Haryana
      • Rohtak, Haryana, Indië, 124001

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

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
  2. Recession depth ≥2mm
  3. Systemically healthy individuals.
  4. Age >18 years old.
  5. Full mouth bleeding and plaque score ≤20%
  6. Patients who agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

  1. Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
  2. Patient with active periodontal disease
  3. Smokers and tobacco users
  4. Mal-aligned tooth with recession.
  5. Patients who had already undergone root coverage procedure on the selected site.
  6. Pregnant and lactating females
  7. Involved tooth with trauma from occlusion.
  8. Involved tooth with prosthesis.
  9. Endodontically involved/ RCT treated tooth
  10. Tooth with cervical abrasion / undetectable CEJ/ carious

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: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft

the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft.

Keratinized tissue width and attached gingiva width are considered important for maintaining gingival health and long-term stability after root coverage. However, there is limited and unclear evidence on how much keratinized or attached gingiva is actually needed for successful root coverage. Most previous studies have focused on soft tissue thickness rather than these parameters.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
root coverage
Tijdsspanne: 6 months
root coverage will be calculated in percentage
6 months

Medewerkers en onderzoekers

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

Onderzoekers

  • Hoofdonderzoeker: Richa Tirkey, PGIDS Rohtak

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 juli 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

2 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

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 .

Abonneren