Back to resultsEffect of Honey and Dexamethason on Extraction Healing
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Early Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Normal saline
Dexamethasone
Honey
Dexamethasone and honey
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Third Molar Tooth
Eligibility Criteria
Inclusion Criteria:
- impacted 3rd molar
- healthy patient No smoking
Exclusion Criteria:
- history of smoking Medical disease
Sites / Locations
- Vision colleges
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
Dexamethason
Natural honey
Dexamethason and natural honey
Arm Description
No drug given before surgery
Dexamethason will be given IV before surgery
Honey will be placed locally after impaction removal
Dexamethason will be given IV before surgery and Honey will be placed locally after impaction removal
Outcomes
Primary Outcome Measures
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Edema
Measured from angle of mandible to angle of mouth
Edema
Measured from angle of mandible to angle of mouth
Edema
Measured from angle of mandible to angle of mouth in mm by ruler
Edema
Measured from angle of mandible to angle hof mouth in mm by ruler
Edema
Measured from angle of mandible to angle of mouth in mm by ruler
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04848259
Brief Title
Effect of Honey and Dexamethason on Extraction Healing
Official Title
A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
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
5. Study Description
Brief Summary
Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No drug given before surgery
Arm Title
Dexamethason
Arm Type
Active Comparator
Arm Description
Dexamethason will be given IV before surgery
Arm Title
Natural honey
Arm Type
Active Comparator
Arm Description
Honey will be placed locally after impaction removal
Arm Title
Dexamethason and natural honey
Arm Type
Active Comparator
Arm Description
Dexamethason will be given IV before surgery and Honey will be placed locally after impaction removal
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Saline will be applied after surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethason will be given IV before surgery
Intervention Type
Drug
Intervention Name(s)
Honey
Intervention Description
Honey will be applied locally after surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and honey
Intervention Description
Dexamethason will be given IV before surgery and then Honey will be applied locally after surgery
Primary Outcome Measure Information:
Title
Interincisal distance
Description
Distance between upper and lower teeth will be measured in mm by ruler
Time Frame
Preoperative
Title
Interincisal distance
Description
Distance between upper and lower teeth will be measured in mm by ruler
Time Frame
I day postoperative
Title
Interincisal distance
Description
Distance between upper and lower teeth will be measured in mm by ruler
Time Frame
3rd day postoperative
Title
Interincisal distance
Description
Distance between upper and lower teeth will be measured in mm by ruler
Time Frame
7th day postoperative
Title
Edema
Description
Measured from angle of mandible to angle of mouth
Time Frame
Preoperative
Title
Edema
Description
Measured from angle of mandible to angle of mouth
Time Frame
1day postoperative
Title
Edema
Description
Measured from angle of mandible to angle of mouth in mm by ruler
Time Frame
2nd day postoperative
Title
Edema
Description
Measured from angle of mandible to angle hof mouth in mm by ruler
Time Frame
3rd day postoperative
Title
Edema
Description
Measured from angle of mandible to angle of mouth in mm by ruler
Time Frame
7th day postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
impacted 3rd molar
healthy patient No smoking
Exclusion Criteria:
history of smoking Medical disease
Facility Information:
Facility Name
Vision colleges
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Effect of Honey and Dexamethason on Extraction Healing
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