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Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05334745
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure

Condition or Disease Intervention/Treatment Phase
  • Other: Alvogyl
 Phase 1

Detailed Description

Postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. Although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. Further, undesired side effects such as delayed wound healing/foreign body reaction have been reported .

No gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of Topical Application of Alvogyl Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing : A Randomized Controlled Clinical Trial
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: application of Alvogyl in the palatal wound with stent

Other: Alvogyl
application of Alvogyl in the palatal wound with stent versus hyaluronic acid application
Other Names:
  • Hyaluronic acid

    		•
    Other: application of 0.2% Hyaluronic acid is placed in the palatal wound with stent .

    Other: Alvogyl
    application of Alvogyl in the palatal wound with stent versus hyaluronic acid application
    Other Names:
  • Hyaluronic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [7th days]

      Pain through one week using the visual analogue scale (VAS)

    Secondary Outcome Measures

    1. Wound healing [7th, 14th, 21st and 30th days.]

      Wound healing index through one month . The healing index has 5 grades which are 5(excellent healing), 4(very good healing), 3 (good healing), 2(poor healing) and 1(very poor healing)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with mucogingival defects scheduled for free gingival graft

    • Age from 18 years up to 60

    • Medically healthy patient

    Exclusion Criteria:

    • Systemic diseases that may be a contraindication for any surgeries.

    • Loss of maxillary premolars and molars.

    • Pregnancy or lactation

    • Smoking

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Egypt Cairo Egypt 11865

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohy eldin mahmoud aboelazayem, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05334745
    Other Study ID Numbers:
    • 01005007001
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries
    Hyaluronic Acid

    Study Results

    No Results Posted as of Apr 19, 2022