NCT03340987

Brief Summary

Patients with multiple recession defects will be randomly oriented into to groups. The test group will recieve a relatively new technique, the VISTA technique, combined with connective tissue graft that will be harvested from the palate. The control group will recieve coronally advanced flap with connective tissue graft. subjects will be followed up for 6 months after the surgery. Any complications, that may occur, will be dealt with.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

September 21, 2017

Last Update Submit

July 3, 2018

Conditions

Gingival Recession

Keywords

vestibular incision subperiosteal tunnel accesscoronally advanced flapsubepithelial connective tissue graftmultiple gingival recessions

Outcome Measures

Primary Outcomes (1)

  • Amount of root coverage

    complete root coverage after surgical correction measured in millimeters by using periodontal probe

    6 months

Secondary Outcomes (8)

  • Root Coverage Esthetic score a numbering score

    6 months

  • Clinical Attachment level gain in millimeters

    6 months

  • Width of Keratinized tissue in millimeters

    6 months

  • Probing depth in millimeters

    6 months

  • Gingival thickness in millimeters

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Vista technique with SCTG

EXPERIMENTAL

vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft

Procedure: vestibular incision subperiosteal tunnel access

coronally advanced flap with SCTG

ACTIVE COMPARATOR

coronally advanced flap combined with subepithelial connective tissue graft

Procedure: Coronally advanced flap

Interventions

vestibular incision subperiosteal tunnel accessPROCEDURE

vertical vestibular incision will be made down to the periosteum followed by creating a tunnel without reflecting the interdental papilla. Then a free gingival graft will be optained from the palate and de-epithelialized extraorally. The connective tissue graft will then be applied through the tunnel and the gingival margin will be sutured and the sutures will be fixed to the tooth surface by flowable composite. Then the vestibular incision will be sutured.

Also known as: Vista technique
Vista technique with SCTG
Coronally advanced flapPROCEDURE

Two horizontal incisions will be made mesial and distal to the recession area followed by two oblique incisions extended to the alveolar mucosa and a full-split thickness flap will be elevated. De-epithelialization will be done to receive the connective tissue graft obtained from the palate by de-epithelializing a free gingival graft. Then the flap will be advanced coronally aand sutured without tension

Also known as: CAF
coronally advanced flap with SCTG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with two or more adjacent teeth with Miller class I or II facial gingival recessions.
  • Good oral hygiene
  • Accepts follow-up period (cooperative patients).
  • Patient provides a signed informed consent.

You may not qualify if:

  • Patients with systemic disease that may affect periodontal health and healing.
  • Current and former smokers
  • Pregnant females.
  • Subjects received any surgical periodontal therapy in the area of interest for minimum of 6 months prior to the study.
  • Subjects taking drugs known to interfere with wound healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Oral and Dental Medicine

Study Record Dates

First Submitted

September 21, 2017

First Posted

November 14, 2017

Study Start

August 1, 2018

Primary Completion

January 1, 2019

Study Completion

August 1, 2019

Last Updated

July 6, 2018

Record last verified: 2018-07