NCT03273010

Brief Summary

The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 3, 2017

Last Update Submit

September 1, 2017

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Primary bleeding time

    The moment of active blood flow stasis that a clinical photograph could be taken by examiner without need for suction.

    baseline

Secondary Outcomes (3)

  • Visual Analog Scale (VAS)

    1-7 days after operation

  • Analgesic consumption

    1-7 days after operation

  • Completion of epithelization

    Once a week for a month after the operation

Study Arms (2)

Periacryl group

EXPERIMENTAL

Periacryl, a tissue adhesive, was applied on wound surfaces to achieve haemostasis

Procedure: Free gingival graftProcedure: Cyanoacrylate application

Control group

ACTIVE COMPARATOR

Free gingival graft was harvested from palatal region and left to heal without applying periacryl.

Procedure: Free gingival graft

Interventions

Free gingival graftPROCEDURE

Free gingival graft was harvested from palatal donor site

Control groupPeriacryl group
Cyanoacrylate applicationPROCEDURE

Periacyrl was applied on palatal wounds

Periacryl group

Eligibility Criteria

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

You may qualify if:

  • no systemic diseases
  • no coagulation disorders
  • no drug intake in the previous 6 months that might effect the periodontal health status
  • no pregnancy or lactation
  • no smoking habit
  • \<1 mm attached gingiva width on one or two lower anterior teeth
  • Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)

You may not qualify if:

  • Hematologic disorders
  • No cooperation

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

September 6, 2017

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 6, 2017

Record last verified: 2017-09