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

December 5, 2016 updated by: Damascus University

The Effect of Topical Application of Manuka Honey on Healing After Extraction of Impacted Lower Third Molars: A Split-Mouth Design Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
    • Damscus
      • Damascus, Damscus, Syrian Arab Republic, DM20AM18
        • Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manuka Honey
Manuka Honey will be placed in the sockets of the extracted third molars in this group
Biological: Manuka Honey
This material is going to be placed into the sockets of the extracted third molars in the experimental group
No Intervention: Traditional Extraction
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
Time Frame: 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.
7 days after the surgical removal of third molars
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.

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
Time Frame: 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.
Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
Pain and Change of pain
Time Frame: This will be assessed on the 3rd and 7th day following surgery
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
Time Frame: 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.
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
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)
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
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
Time Frame: at 3 and six months following surgery
This will be assessed using panoramic radiographs
at 3 and six months following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Nuraldeen Al-Khanati, DDS, MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
  • Study Director: Yasser Al-Moudallal, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OMFS-04-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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