search
Back to results

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

Primary Purpose

Pain, Procedural

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Gelatin Sponge Sheet
Alvogyl
Sponsored by
Karim ehab gerges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring alveogyl, gelatin sponge, free gingival graft, palate, pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control group

    intervention group

    Arm Description

    Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site

    alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain

    Outcomes

    Primary Outcome Measures

    pain score
    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

    healing
    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).
    bleeding
    Questionaire, Binary (yes or no).
    analgesic consumption
    questionaure, Numerical, Amount of analgesics daily consumption

    Full Information

    First Posted
    December 27, 2017
    Last Updated
    February 6, 2019
    Sponsor
    Karim ehab gerges
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03402321
    Brief Title
    Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting
    Official Title
    Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    July 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Karim ehab gerges

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Procedural
    Keywords
    alveogyl, gelatin sponge, free gingival graft, palate, pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site
    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain
    Intervention Type
    Drug
    Intervention Name(s)
    Gelatin Sponge Sheet
    Other Intervention Name(s)
    gel foam
    Intervention Description
    sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
    Intervention Type
    Drug
    Intervention Name(s)
    Alvogyl
    Other Intervention Name(s)
    Alveogyl
    Intervention Description
    paste form with analgesic action to protect the palatal donor site and help to relief pain
    Primary Outcome Measure Information:
    Title
    pain score
    Description
    recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    healing
    Description
    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).
    Time Frame
    4 weeks
    Title
    bleeding
    Description
    Questionaire, Binary (yes or no).
    Time Frame
    2 weeks
    Title
    analgesic consumption
    Description
    questionaure, Numerical, Amount of analgesics daily consumption
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting Systemically healthy Exclusion Criteria: Severe gagging reflex Smokers Occlusal trauma at site of graft Pregnancy Psychiatric disorder Patients allergic to the used agents

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32144515
    Citation
    Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs