NCT03665272

Brief Summary

The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

September 5, 2018

Last Update Submit

September 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • deepithelialized gingival graft blood perfusion change

    Blood perfusions (units) were measured by laser doppler flowmetry

    measurements were performed at the day of surgery, 1, 3 and 7 days.

Secondary Outcomes (1)

  • Deepithelialized gingival graft recipient bed pain changes

    measurements were performed at 1, 3 and 7 days post surgery.

Study Arms (2)

fixation by tissue adhesive

EXPERIMENTAL

In this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture.

Procedure: deepithelialized gingival graft fixation

fixation by sutures

EXPERIMENTAL

In this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures.

Procedure: deepithelialized gingival graft fixation

Interventions

one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.

fixation by suturesfixation by tissue adhesive

Eligibility Criteria

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

You may qualify if:

  • to 65 years of age
  • systemically healthy
  • inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region
  • no restorations on the lower incisor region
  • no mucogingival surgical history in the lower incisor region
  • no periodontal treatment within the previous year
  • no systemic antibiotics taken for 6 months before the study
  • not pregnant or lactating
  • no-smoking

You may not qualify if:

  • lower 18 and upper than 65 years of age
  • systemical disease
  • adequate amount of keratinized gingiva on the labial side of the lower incisor region
  • restorations on the lower incisor region
  • mucogingival surgical history in the lower incisor region
  • periodontal treatment within the previous year
  • systemic antibiotics taken for ‡6months before the study
  • pregnancy or lactating
  • smoking history or current smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekeriya Taşdemir

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Study Officials

  • zekeriya taşdemir, phd

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal investigator

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 11, 2018

Study Start

January 10, 2018

Primary Completion

September 3, 2018

Study Completion

September 3, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations