NCT04970524

Brief Summary

In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues. This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

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

May 5, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

April 8, 2021

Last Update Submit

September 12, 2021

Conditions

Gingival Recession

Keywords

Partial de-epithelialized free gingival graft

Outcome Measures

Primary Outcomes (1)

  • aesthetic evaluation of both surgical methods

    Aesthetic evaluation of both surgical methods was done by a blinded researcher by photo analysis. For photo analysis, photographs of the recipient area were taken at the beginning and 6 months after the operation with the help of Adobe Photoshop program and evaluated on these photographs.

    change in post-op 6 months

Secondary Outcomes (1)

  • clinical parameters

    change in post-op 6 months

Study Arms (2)

control group(conventional free gingival graft)

EXPERIMENTAL

Conventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins.

Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

test group(Partially de-epithelialized free gingival graft)

EXPERIMENTAL

Partial free gingival graft is applied to the areas of the patients determined by randomization. Unlike the control group, the epithelium on the graft was partially epithelialized.

Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

Interventions

Comparison of conventional free gingival graft versus partial free gingival graftPROCEDURE

Conventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization. Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.

control group(conventional free gingival graft)

Eligibility Criteria

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

You may qualify if:

  • Absence of known systemic disease
  • Not using any medication that may affect the periodontal tissues or prolong the bleeding time
  • Having not previously operated on the palate area, which is both the receiving area and the donor area.
  • The depth of the probing sulcus of all teeth is \<3 mm
  • Whole mouth plaque index and gingival index scores \<1
  • The teeth in the operation area are vital
  • Absence of caries and / or restoration on the root surfaces of the teeth in the operation area
  • Lack of attached gingiva in opposite jaws

You may not qualify if:

  • Pregnant or lactating women,
  • Smoking individuals,
  • Individuals under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University Faculty of dentistry, Periodontology department

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • Naziker Y, Ertugrul AS. Aesthetic evaluation of free gingival graft applied by partial de-epithelialization and free gingival graft applied by conventional method: a randomized controlled clinical study. Clin Oral Investig. 2023 Jul;27(7):4029-4038. doi: 10.1007/s00784-023-05029-8. Epub 2023 Apr 28.

    PMID: 37118334DERIVED

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
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator Yonca Naziker

Study Record Dates

First Submitted

April 8, 2021

First Posted

July 21, 2021

Study Start

May 5, 2019

Primary Completion

September 15, 2020

Study Completion

February 4, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)