Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Drug: Sterile gauze pack; Drug: Colloidal silver gelatin sponge

• Registration Number: NCT05850819
• Lead Sponsor: Melaka Manipal Medical College

Brief Summary

This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

Detailed Description

In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.

In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Study First Submitted: 2023-04-29
• Study First Submitted QC: 2023-04-29
• Status Verified: 2023-05
• Study First Posted: 2023-05-09
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients requiring extraction of mandibular teeth
• Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
• Patients not allergic to the drugs or anesthetics used in the study.

Exclusion Criteria

• Patients taking medications that influences wound healing
• smokers
• Uncooperative patients
• Patients requiring extraction of grade II or III mobile teeth
• Patients requiring surgical extraction of teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Sterile gauze pack	Extraction socket allowed to heal without application of Gelatamp
Group A	Colloidal silver gelatin sponge	Application of Gelatamp in the extraction socket

Primary Outcome Measures

Name	Time	Method
Postoperative wound healing	7th postoperative day	A 5 point early wound healing scale assessing wound healing after 7 postoperative days
postoperative pain	5th postoperative day	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Postoperative pain	2nd postoperative day	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

Secondary Outcome Measures

Name	Time	Method
Presence of dry socket	3rd postoperative day	presence of pain, foul odour, exposed bone in the extraction socket

Trial Locations

Locations (1)

Melaka Manipal Medical College; 🇲🇾 Melaka, Malaysia