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

May 9, 2023 updated by: Abdul Kalam Azad, Melaka Manipal Medical College

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Melaka, Malaysia, 75150
        • Melaka Manipal Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Application of Gelatamp in the extraction socket
Drug: Colloidal silver gelatin sponge
Augment the extraction socket with Gelatamp
Other Names:
  • Gelatamp
Active Comparator: Group B
Extraction socket allowed to heal without application of Gelatamp
Drug: Sterile gauze pack
Extraction socket allowed to heal without augmentation with any material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative wound healing
Time Frame: 7th postoperative day
A 5 point early wound healing scale assessing wound healing after 7 postoperative days
7th postoperative day
Postoperative pain
Time Frame: 1st postoperative day
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
Postoperative pain
Time Frame: 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).
2nd postoperative day
postoperative pain
Time Frame: 3rd postoperative day
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
postoperative pain
Time Frame: 4th postoperative day
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
postoperative pain
Time Frame: 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).
5th postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of dry socket
Time Frame: 3rd postoperative day
presence of pain, foul odour, exposed bone in the extraction socket
3rd postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melaka Manipal Medical College

Investigators

  • Principal Investigator: Abdul K Azad, Melaka Manipal Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

April 29, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUCM/FOD/AR/B10/E C-2022(03)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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