Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting

February 6, 2019 updated by: Karim ehab gerges

Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial

clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
  2. Systemically healthy

Exclusion Criteria:

  1. Severe gagging reflex
  2. Smokers
  3. Occlusal trauma at site of graft
  4. Pregnancy
  5. Psychiatric disorder
  6. Patients allergic to the used agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: control group
Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site
Drug: Gelatin Sponge Sheet
sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
Other Names:
  • gel foam
EXPERIMENTAL: intervention group
alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain
Drug: Alvogyl
paste form with analgesic action to protect the palatal donor site and help to relief pain
Other Names:
  • Alveogyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 2 weeks
recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing
Time Frame: 4 weeks
healing of the palatal mucosa using H2O2 Test this test is based on the principle that if the epithelium is discontinuous, then H2O2 diffuses into the CT, the enzyme catalase acts on H2O2to release water and oxygen. This is shown clinically by the production of bubbles on the wound. The area to be evaluated is then dried, and 3% H2O2 is sprinkled on the wound with a syringe, waiting for the appearance of bubbles, which will suggest that the surgical site is not completely epithelialized. Complete healing will be recorded as a dichotomous variable (yes/no).
4 weeks
bleeding
Time Frame: 2 weeks
Questionaire, Binary (yes or no).
2 weeks
analgesic consumption
Time Frame: 2 weeks
questionaure, Numerical, Amount of analgesics daily consumption
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karim ehab gerges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

January 10, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1792013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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