NCT05777811

Brief Summary

In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 9, 2023

Last Update Submit

March 22, 2023

Conditions

Shallow Vestibular DepthGingival Recession

Outcome Measures

Primary Outcomes (8)

  • Vestibule depth 2

    The distance between the free gingival margin and the most apical point of the vestibul.

    Baseline

  • Vestibule depth 2

    The distance between the free gingival margin and the most apical point of the vestibul.

    3rd month

  • Vestibule depth 2

    The distance between the free gingival margin and the most apical point of the vestibul.

    6th month

  • Vestibule depth 2

    The distance between the free gingival margin and the most apical point of the vestibul.

    12th month.

  • Vestibule depth 1

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

    Baseline

  • Vestibule depth 1

    The distance between the free semento enamel junction and the most apical point of the vestibul.

    3rd month

  • Vestibule depth 1

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

    6th month

  • Vestibule depth 1

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

    12th month

Secondary Outcomes (25)

  • Recession depth (RD)

    Baseline

  • Recession depth (RD)

    6th week

  • Recession depth (RD)

    6th month.

  • Recession depth (RD)

    12th month.

  • Probing depth (PD)

    Baseline

  • +20 more secondary outcomes

Study Arms (2)

Vertically Coronally advanced flap combined with connective tissue graft

ACTIVE COMPARATOR
Procedure: Vertically coronally advanced flap combined with connective tissue graft.

Free Gingival Graft

ACTIVE COMPARATOR
Procedure: Free gingival graft

Interventions

Vertically coronally advanced flap combined with connective tissue graft.PROCEDURE

The exposed root surfaces are planed with Gracey 1-2 curettes. An intrasulcular incision is made with a blade on the buccal aspects of the involved teeth. The incision is extended horizontally to the adjacent papilla. Then, slightly divergent vertical releasing incisions are carried 2 mm beyond the mucogingival junction. A full-thickness flap is raised with a periosteal elevator towards the mucogingival junction. After that, a partial-thickness dissection is carried out in the apical direction to release muscle tension and provide coronal advancement of the flap. The adjacent papillae are de-epithelialized. The connective tissue graft (CTG) is harvested from the lateral palate using the de-epithelialized gingival graft technique. After harvesting, the connective tissue graft is sutured to the recipient bed. Finally, the flap is positioned 2 mm over the cementoenamel junction and sutured with 6-0 polypropylene sutures. No periodontal dressing is applied.

Vertically Coronally advanced flap combined with connective tissue graft
Free gingival graftPROCEDURE

A partial-thickness flap is elevated (using a blade #15c) with horizontal incisions at the cemento-enamel junction (CEJ) level of the adjacent teeth. Then, two vertical incisions extending to the apical are made from the two ends of the horizontal incision. The epithelium in the framed region is removed with a scalpel, and the underlying connective tissue is exposed. To achieve the best vascularization of the free gingival graft from the recipient site, bed preparation is completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. The free gingival graft is stabilized using interrupted sutures and a sling suture.

Also known as: epithelialized free gingival graft
Free Gingival Graft

Eligibility Criteria

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

You may qualify if:

  • full-mouth plaque and bleeding scores \<15%
  • the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
  • the presence of an identifiable cemento-enamel junction

You may not qualify if:

  • Vestibule depth \> 6mm
  • Smoking \> 10 cigarettes per day
  • Any contraindications for periodontal surgery
  • Unstable endodontic conditions or presence of any restoration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Parlak HM, Yilmaz BT, Durmaz MH, Toz H, Keceli HG. The effects of vertically coronally advanced flap and free gingival graft techniques on shallow vestibule: a randomized comparative prospective trial. Clin Oral Investig. 2023 Dec;27(12):7425-7436. doi: 10.1007/s00784-023-05332-4. Epub 2023 Oct 19.

    PMID: 37855920DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients were randomly assigned to either the Vertically Coronally Advanced Flap (n=25) group or the Free Gingival Graft (n=25) group by one of the authors, with an allocation ratio of 1:1, using a computer-generated program after the successful completion of Phase I periodontal treatment. One calibrated author applied the surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 3, 2021

Primary Completion

January 3, 2023

Study Completion

January 15, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

TU(1)