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Trial record 27 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03402321
Recruitment Status : Not yet recruiting
First Posted : January 18, 2018
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
Karim ehab gerges, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Procedural Drug: Gelatin Sponge Sheet Drug: Alvogyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

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 Name: 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 Name: Alveogyl

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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).

  2. bleeding [ Time Frame: 2 weeks ]
    Questionaire, Binary (yes or no).

  3. analgesic consumption [ Time Frame: 2 weeks ]
    questionaure, Numerical, Amount of analgesics daily consumption

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Karim ehab gerges, Principal Investigator, Cairo University Identifier: NCT03402321     History of Changes
Other Study ID Numbers: 1792013
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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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

Keywords provided by Karim ehab gerges, Cairo University:
alveogyl, gelatin sponge, free gingival graft, palate, pain

Additional relevant MeSH terms:
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Pain, Procedural
Neurologic Manifestations
Signs and Symptoms