Gum Health Gel in Post Extraction Sockets (Gum Health gel)

February 15, 2024 updated by: Dhuha Ali Bardan, University of Baghdad

Effectiveness of Gum Health Gel in Minimizing Post Operative Sequelae Associated With the Surgical Removal of Impacted Mandibular Third Molars

This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus

Study Type

Interventional

Enrollment (Estimated)

52

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 Contact

Study Locations

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: Horizontal and mesioangular impaction in healthy patients older than 18 years old -

Exclusion Criteria:any medically compromised patient and the presence of any infection

-

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
Active Comparator: Study group gum Health gel
Study group we fill the sockets with gel foam immersed with Gum Health gel
Procedure: Gum Health gel
Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket with normal saline, and filling the socket with the Gum Health gel
Placebo Comparator: Control group gel foam
Control group we fill the sockets with gel foam only
Procedure: Gel foam
Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of Pain
Time Frame: One week
Pain with Visual analog scale
One week
Increase Soft tissue healing
Time Frame: One week
Soft tissue healing with Early wound healing scale
One week
Decrease in Trismus
Time Frame: One week
Trismus with Maximum-interincisal- opening (MIO) thatimillimeters
One week
Decrease of Swelling
Time Frame: One week
Swelling withGrades of swelling
One week

Collaborators and Investigators

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

Sponsor

University of Baghdad

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)

February 15, 2024

Primary Completion (Estimated)

August 19, 2024

Study Completion (Estimated)

September 19, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 894124

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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