The Use of Manuka Honey to Improve Healing After Third Molars Surgery

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
Sufficient evidence exists recommending the use of honey in the management of acute wounds and burns. Studies revealed that the healing effect of honey could be classified by its antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components. Manuka honey has been shown to inhibit a wide range of microorganisms, including multiresistant strains. This unique honey is derived from flowers of manuka tree (Leptospermum scoparium) in New Zealand. Dihydroxyacetone and methylglyoxal are unique and naturally occurring constituents of manuka honey that correlate with its antibacterial activity. Since surgical extraction of impacted molars is one of the most common operations in the oral cavity and the postoperative symptoms disturbing the patient may reduce the quality of health service, this study aims to assess the healing potential of Manuka honey in reducing these symptoms by comparing the outcome of extraction of impacted lower molars with and without topical application of Manuka honey into the extraction socket.

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

Conditions
-----------------
Surgical Extraction of Impacted Third Molars

Intervention / Treatment
-----------------
* Biological: Manuka Honey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic, Symmetrical, Bilateral Impacted Third Molars Exclusion Criteria: Uncontrolled diabetes, Hypersensitivity to Honey Alcoholism, Drug abuse, Pathological condition in the region

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manuka Honey<br>Manuka Honey will be placed in the sockets of the extracted third molars in this group | Biological: Manuka Honey<br>* This material is going to be placed into the sockets of the extracted third molars in the experimental group<br>|
| No Intervention: Traditional Extraction<br>No any special material will be placed in the sockets of the extracted third molars in this group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| Change of bone healing status | This will be assessed using panoramic radiographs | at 3 and six months following surgery |