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

Not Applicable

Completed

• Conditions: Surgical Extraction of Impacted Third Molars
• Interventions: Biological: Manuka Honey

• Registration Number: NCT02483741
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion Criteria

• Uncontrolled diabetes,
• Hypersensitivity to Honey
• Alcoholism,
• Drug abuse,
• Pathological condition in the region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manuka Honey	Manuka Honey	Manuka Honey will be placed in the sockets of the extracted third molars in this group

Primary Outcome Measures

Name	Time	Method
The presence or absence of alveolar osteitis	This will be assessed on the 3rd and 7th day following surgery	The presence of a dry socket condition will be checked out at two time points.
Change of the masticatory muscles status	Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.	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.
Levels of postoperative discomfort	7 days after the surgical removal of third molars	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.
Pain and Change of pain	This will be assessed on the 3rd and 7th day following surgery	using a Visual Analog Scale of Faces (VASoF).
Change of facial contours due to swelling	Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.	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.

Secondary Outcome Measures

Name	Time	Method
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	at six months following surgery	This will be assessed using Cone-beam computed tomography (CBCT) images. Hounsfield Units will be used to quantify bone density and quality.
Change of bone healing status	at 3 and six months following surgery	This will be assessed using panoramic radiographs

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, University of Damascus Dental School; 🇸🇾 Damascus, Damscus, Syrian Arab Republic