NCT03814707

Brief Summary

Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure . .

Trial Health

43
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 Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 10, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 13, 2019

Last Update Submit

January 25, 2019

Conditions

Pain, Postoperative

Keywords

gingival recessiongingival augmentationfree gingival graftplatelet rich fibrin in wound healing2 steps free gingival grafthyaluronic acid in wound healing

Outcome Measures

Primary Outcomes (1)

  • post operative pain

    Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst

    1 week

Secondary Outcomes (1)

  • wound healing

    2 months

Study Arms (2)

Topical application 0.2%Hyaluronic Acid

ACTIVE COMPARATOR

Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack

Drug: Topical application of 0.2% hyaluronic acid gel

Platelet Rich Fibrin

EXPERIMENTAL

Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.

Biological: Platelet rich fibrin

Interventions

Topical application of 0.2% hyaluronic acid gelDRUG

Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting

Also known as: gengigel
Topical application 0.2%Hyaluronic Acid
Platelet rich fibrinBIOLOGICAL

Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.

Platelet Rich Fibrin

Eligibility Criteria

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

You may qualify if:

  • Patients with mucogingival defects scheduled for free gingival graft
  • Age at least 18 years.
  • Not having any systemic disease that could compromise wound healing
  • No previous periodontal surgery on the experimental sites.

You may not qualify if:

  • Systemic diseases that may be a contraindication for any surgeries.
  • Loss of maxillary premolars and molars.
  • Pregnancy or lactation
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine - Cairo University -

Giza, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeGingival Recession

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mona M Shoeib, P.H.D

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mostafa M Soliman, B.D.S

CONTACT

002-01007034062drshoo_2010@hotmail.com

Mona M Shoeib, P.H.D

CONTACT

002-01223102216monashoeib@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
both the participants and the investigator can't be blinded only outcome assessor will be blinded .
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment * A randomized clinical trial. * Parallel group study. * A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 24, 2019

Study Start

January 10, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)