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

Primary Purpose

Wound Heal

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Colloidal silver gelatin sponge
Sterile gauze pack
Sponsored by
Melaka Manipal Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Melaka Manipal Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Application of Gelatamp in the extraction socket

Extraction socket allowed to heal without application of Gelatamp

Outcomes

Primary Outcome Measures

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

Presence of dry socket
presence of pain, foul odour, exposed bone in the extraction socket

Full Information

First Posted
April 29, 2023
Last Updated
May 9, 2023
Sponsor
Melaka Manipal Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05850819
Brief Title
Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial
Official Title
Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Melaka Manipal Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Application of Gelatamp in the extraction socket
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Extraction socket allowed to heal without application of Gelatamp
Intervention Type
Drug
Intervention Name(s)
Colloidal silver gelatin sponge
Other Intervention Name(s)
Gelatamp
Intervention Description
Augment the extraction socket with Gelatamp
Intervention Type
Drug
Intervention Name(s)
Sterile gauze pack
Intervention Description
Extraction socket allowed to heal without augmentation with any material
Primary Outcome Measure Information:
Title
Postoperative wound healing
Description
A 5 point early wound healing scale assessing wound healing after 7 postoperative days
Time Frame
7th postoperative day
Title
Postoperative pain
Description
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Time Frame
1st postoperative day
Title
Postoperative pain
Description
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Time Frame
2nd postoperative day
Title
postoperative pain
Description
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Time Frame
3rd postoperative day
Title
postoperative pain
Description
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Time Frame
4th postoperative day
Title
postoperative pain
Description
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Time Frame
5th postoperative day
Secondary Outcome Measure Information:
Title
Presence of dry socket
Description
presence of pain, foul odour, exposed bone in the extraction socket
Time Frame
3rd postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul K Azad
Organizational Affiliation
Melaka Manipal Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melaka Manipal Medical College
City
Melaka
ZIP/Postal Code
75150
Country
Malaysia

12. IPD Sharing Statement

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

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