Effect of Honey and Dexamethason on Extraction Healing

July 20, 2021 updated by: Alaa Altaweel, Al-Azhar University

A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal

Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated

Study Overview

Detailed Description

Patient with impacted lower third molar will be selected to this study agording to agent applied preoperative. Group 1 will receive topical honey and Group 2 will receive IV dexamethason. After surgical removal of impacted tooth under local anesthesia postoperative pain mouth opening, and swelling will be evaluated

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • impacted 3rd molar
  • healthy patient No smoking

Exclusion Criteria:

  • history of smoking Medical disease

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
No drug given before surgery
Saline will be applied after surgery
ACTIVE_COMPARATOR: Dexamethason
Dexamethason will be given IV before surgery
Dexamethason will be given IV before surgery
ACTIVE_COMPARATOR: Natural honey
Honey will be placed locally after impaction removal
Honey will be applied locally after surgery
ACTIVE_COMPARATOR: Dexamethason and natural honey
Dexamethason will be given IV before surgery and Honey will be placed locally after impaction removal
Dexamethason will be given IV before surgery and then Honey will be applied locally after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interincisal distance
Time Frame: Preoperative
Distance between upper and lower teeth will be measured in mm by ruler
Preoperative
Interincisal distance
Time Frame: I day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
I day postoperative
Interincisal distance
Time Frame: 3rd day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
3rd day postoperative
Interincisal distance
Time Frame: 7th day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
7th day postoperative
Edema
Time Frame: Preoperative
Measured from angle of mandible to angle of mouth
Preoperative
Edema
Time Frame: 1day postoperative
Measured from angle of mandible to angle of mouth
1day postoperative
Edema
Time Frame: 2nd day postoperative
Measured from angle of mandible to angle of mouth in mm by ruler
2nd day postoperative
Edema
Time Frame: 3rd day postoperative
Measured from angle of mandible to angle hof mouth in mm by ruler
3rd day postoperative
Edema
Time Frame: 7th day postoperative
Measured from angle of mandible to angle of mouth in mm by ruler
7th day postoperative

Collaborators and Investigators

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

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)

January 5, 2021

Primary Completion (ACTUAL)

June 20, 2021

Study Completion (ACTUAL)

June 27, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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