- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04848259
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
-
Jeddah, Saudi Arabia
- Vision colleges
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-
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
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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
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Preoperative
|
Edema
Time Frame: 1day postoperative
|
Measured from angle of mandible to angle of mouth
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1day postoperative
|
Edema
Time Frame: 2nd day postoperative
|
Measured from angle of mandible to angle of mouth in mm by ruler
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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.
Sponsor
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
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Diseases
- Tooth, Impacted
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- Impaction
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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