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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 January 2017
Main ID:  NCT02483741
Date of registration: 25/06/2015
Prospective Registration: No
Primary sponsor: Damascus University
Public title: The Use of Manuka Honey to Improve Healing After Third Molars Surgery
Scientific title: The Effect of Topical Application of Manuka Honey on Healing After Extraction of Impacted Lower Third Molars: A Split-Mouth Design Randomized Controlled Trial
Date of first enrolment: June 2015
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02483741
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Syrian Arab Republic
Contacts
Name:     Yasser Al-Moudallal, DDS MSc PhD
Address: 
Telephone:
Email:
Affiliation:  Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School
Name:     Nuraldeen Al-Khanati, DDS
Address: 
Telephone:
Email:
Affiliation:  MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
Key inclusion & exclusion criteria

Inclusion Criteria:

- Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion Criteria:

- Uncontrolled diabetes,

- Hypersensitivity to Honey

- Alcoholism,

- Drug abuse,

- Pathological condition in the region



Age minimum: 20 Years
Age maximum: 37 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Surgical Extraction of Impacted Third Molars
Intervention(s)
Biological: Manuka Honey
Primary Outcome(s)
Change of facial contours due to swelling [Time Frame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.]
Levels of postoperative discomfort [Time Frame: 7 days after the surgical removal of third molars]
Pain and Change of pain [Time Frame: This will be assessed on the 3rd and 7th day following surgery]
The presence or absence of alveolar osteitis [Time Frame: This will be assessed on the 3rd and 7th day following surgery]
Change of the masticatory muscles status [Time Frame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.]
Secondary Outcome(s)
Time required to hemostasis [Time Frame: This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery)]
Bone density and quality [Time Frame: at six months following surgery]
Change of bone healing status [Time Frame: at 3 and six months following surgery]
Secondary ID(s)
UDDS-OMFS-04-2015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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