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

Sponsor
Melaka Manipal Medical College (Other)
Overall Status
Completed
CT.gov ID
NCT05850819
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Colloidal silver gelatin sponge
  • Drug: Sterile gauze pack
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Mar 30, 2023
Actual Study Completion Date :
Mar 30, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative wound healing [7th postoperative day]

      A 5 point early wound healing scale assessing wound healing after 7 postoperative days

    2. Postoperative pain [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).

    3. 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).

    4. postoperative pain [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).

    5. postoperative pain [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).

    6. 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).

    Secondary Outcome Measures

    1. Presence of dry socket [3rd postoperative day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Melaka Manipal Medical College Melaka Malaysia 75150

    Sponsors and Collaborators

    • Melaka Manipal Medical College

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdul Kalam Azad, Assistant Professor, Melaka Manipal Medical College
    ClinicalTrials.gov Identifier:
    NCT05850819
    Other Study ID Numbers:
    • MUCM/FOD/AR/B10/E C-2022(03)
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 11, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of May 11, 2023