Back to resultsClinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing
Primary Purpose
Wound Healing
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Alvogyl
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
Eligibility Criteria
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
Sites / Locations
- EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
application of Alvogyl in the palatal wound with stent
application of 0.2% Hyaluronic acid is placed in the palatal wound with stent .
Arm Description
Outcomes
Primary Outcome Measures
postoperative pain
Pain through one week using the visual analogue scale (VAS)
Secondary Outcome Measures
Wound healing
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334745
Brief Title
Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
application of Alvogyl in the palatal wound with stent
Arm Type
Experimental
Arm Title
application of 0.2% Hyaluronic acid is placed in the palatal wound with stent .
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Alvogyl
Other Intervention Name(s)
Hyaluronic acid
Intervention Description
application of Alvogyl in the palatal wound with stent versus hyaluronic acid application
Primary Outcome Measure Information:
Title
postoperative pain
Description
Pain through one week using the visual analogue scale (VAS)
Time Frame
7th days
Secondary Outcome Measure Information:
Title
Wound healing
Description
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)
Time Frame
7th, 14th, 21st and 30th days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohy eldin aboelazayem, TA
Phone
+201005007001
Email
mohy.aboelazayem@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa Nasr, PHD
Phone
+01272789994
Email
dr.shaimaanasr@gmail.com
Facility Information:
Facility Name
Egypt
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohyeldin aboelazayem, TA
Phone
+201005007001
Email
mohy.aboelazayem@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
shaimaa nasr, PHD
Phone
+201272789994
Email
dr.shaimaanasr@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing
We'll reach out to this number within 24 hrs