Surgical Extraction of Impacted Third Molars Clinical Trial
Official 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
| Verified date | December 2016 |
| Source | Damascus University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Syria: Ministry of Higher Education |
| Study type | Interventional |
Since there is an evidence that Manuka honey is an antibacterial agent, the present study aims to confirm this characteristic and assess its effect in improving healing and reducing postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular third molars
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | November 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 37 Years |
| Eligibility |
Inclusion Criteria: - Asymptomatic, Symmetrical, Bilateral Impacted Third Molars Exclusion Criteria: - Uncontrolled diabetes, - Hypersensitivity to Honey - Alcoholism, - Drug abuse, - Pathological condition in the region |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Syrian Arab Republic | Department of Oral and Maxillofacial Surgery, University of Damascus Dental School | Damascus | Damscus |
| Lead Sponsor | Collaborator |
|---|---|
| Damascus University |
Syrian Arab Republic,
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Mavric E, Wittmann S, Barth G, Henle T. Identification and quantification of methylglyoxal as the dominant antibacterial constituent of Manuka (Leptospermum scoparium) honeys from New Zealand. Mol Nutr Food Res. 2008 Apr;52(4):483-9. doi: 10.1002/mnfr.200700282. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Levels of postoperative discomfort | Postoperative Symptom Severity (PoSSe) Scale will be used for this variable. The patient will be asked to fill in a questionnaire on the 7th day following surgery. This questionnaire is used to assess postoperative discomfort in patients who have third molars extracted. PoSSe Scale consists of 7 sub-scales that investigate the patient's ability to enjoy food; speak properly; perceive altered sensations, appearance, pain, and sickness; and interference with daily activities. | 7 days after the surgical removal of third molars | No |
| Primary | Change of facial contours due to swelling | In order to assess facial swelling, the distances between the labial commissure and the tragus, and between the lateral canthus and the gonion will be measured. The change between 3 days and before surgery will give an idea about the amount of swelling that occurred following surgery. Between 3 days and 7 days will give an idea about the change that occurred in this period. |
Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery. | No |
| Primary | Change of the masticatory muscles status | Mouth opening range will be assessed by measuring the distance between the upper and lower incisors using a vernier caliper when the patient is asked to open his/her mouth as much as possible. The presence of limited opening of the mouth is an indication of trismus. |
Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery. | No |
| Primary | Pain and Change of pain | using a Visual Analog Scale of Faces (VASoF). | This will be assessed on the 3rd and 7th day following surgery | No |
| Primary | The presence or absence of alveolar osteitis | The presence of a dry socket condition will be checked out at two time points. | This will be assessed on the 3rd and 7th day following surgery | No |
| Secondary | Time required to hemostasis | This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery) | No | |
| Secondary | Bone density and quality | This will be assessed using Cone-beam computed tomography (CBCT) images. Hounsfield Units will be used to quantify bone density and quality. | at six months following surgery | No |
| Secondary | Change of bone healing status | This will be assessed using panoramic radiographs | at 3 and six months following surgery | No |