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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850819
• Other study ID #: MUCM/FOD/AR/B10/E C-2022(03)
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2023
• Source: Melaka Manipal Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Drug:
• Colloidal silver gelatin sponge
Augment the extraction socket with Gelatamp
• Sterile gauze pack
Extraction socket allowed to heal without augmentation with any material

Locations

Country	Name	City	State
Malaysia	Melaka Manipal Medical College	Melaka

Sponsors (1)

Lead Sponsor	Collaborator
Melaka Manipal Medical College

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative wound healing	A 5 point early wound healing scale assessing wound healing after 7 postoperative days	7th postoperative day
Primary	Postoperative pain	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).	1st postoperative day
Primary	Postoperative pain	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).	2nd postoperative day
Primary	postoperative pain	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).	3rd postoperative day
Primary	postoperative pain	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).	4th postoperative day
Primary	postoperative pain	A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).	5th postoperative day
Secondary	Presence of dry socket	presence of pain, foul odour, exposed bone in the extraction socket	3rd postoperative day