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NCT03402321 Clinical Trial

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

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03402321
Other study ID # 1792013
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2019
Est. completion date July 1, 2019

Study information
Verified date February 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date July 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gelatin Sponge Sheet
sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
• Alvogyl
paste form with analgesic action to protect the palatal donor site and help to relief pain

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Karim ehab gerges

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 2 weeks
Secondary 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). 4 weeks
Secondary bleeding Questionaire, Binary (yes or no). 2 weeks
Secondary analgesic consumption questionaure, Numerical, Amount of analgesics daily consumption 2 weeks
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