NCT02521467

Brief Summary

Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

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 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

July 28, 2015

Last Update Submit

August 10, 2015

Conditions

Platelets Rich Fibrin, Palatal Donor Tissue

Outcome Measures

Primary Outcomes (2)

  • Pain Assessment by Visual Analog Scale (VAS)

    VAS ranged from 0 (no pain ) to 10 (severe pain)

    1 week postoperative

  • Clinical healing of the palate

    color match, consistency and thickness of palate (Composite measure)

    2 weeks postoperative

Study Arms (2)

PRF

ACTIVE COMPARATOR

Platelets Rich Fibrin

Biological: Platelets Rich Fibrin in healing of palatal donor tissue

palatal stent

PLACEBO COMPARATOR

Palatal stent

Other: Placebo

Interventions

Platelets Rich Fibrin in healing of palatal donor tissueBIOLOGICAL

Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.

PRF
PlaceboOTHER

the other group is a control group, had no biologic in the palatal wound, only palatal stent

Also known as: Palatal stent
palatal stent

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation

You may not qualify if:

  • High arched palate, medically compromised

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer Oral Periodontology Department

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 13, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08