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

Phase 4

• Conditions: Pain, Procedural
• Interventions: Drug: Gelatin Sponge Sheet; Drug: Alvogyl

• Registration Number: NCT03402321
• Lead Sponsor: Karim ehab gerges

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08
• Study Start: 2019-04-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Gelatin Sponge Sheet	Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site
intervention group	Alvogyl	alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain

Primary Outcome Measures

Name	Time	Method
pain score	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

Name	Time	Method
bleeding	2 weeks	Questionaire, Binary (yes or no).
healing	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).
analgesic consumption	2 weeks	questionaure, Numerical, Amount of analgesics daily consumption