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

Primary Purpose

Surgical Extraction of Impacted Third Molars

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Manuka Honey
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Extraction of Impacted Third Molars

Eligibility Criteria

20 Years - 37 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion Criteria:

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

Sites / Locations

  • Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Manuka Honey

Traditional Extraction

Arm Description

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

No any special material will be placed in the sockets of the extracted third molars in this group

Outcomes

Primary Outcome Measures

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.
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.
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.
Pain and Change of pain
using a Visual Analog Scale of Faces (VASoF).
The presence or absence of alveolar osteitis
The presence of a dry socket condition will be checked out at two time points.

Secondary Outcome Measures

Time required to hemostasis
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.
Change of bone healing status
This will be assessed using panoramic radiographs

Full Information

First Posted
June 25, 2015
Last Updated
December 5, 2016
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02483741
Brief Title
The Use of Manuka Honey to Improve Healing After Third Molars Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Extraction of Impacted Third Molars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manuka Honey
Arm Type
Experimental
Arm Description
Manuka Honey will be placed in the sockets of the extracted third molars in this group
Arm Title
Traditional Extraction
Arm Type
No Intervention
Arm Description
No any special material will be placed in the sockets of the extracted third molars in this group
Intervention Type
Biological
Intervention Name(s)
Manuka Honey
Intervention Description
This material is going to be placed into the sockets of the extracted third molars in the experimental group
Primary Outcome Measure Information:
Title
Levels of postoperative discomfort
Description
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.
Time Frame
7 days after the surgical removal of third molars
Title
Change of facial contours due to swelling
Description
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.
Time Frame
Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
Title
Change of the masticatory muscles status
Description
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.
Time Frame
Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
Title
Pain and Change of pain
Description
using a Visual Analog Scale of Faces (VASoF).
Time Frame
This will be assessed on the 3rd and 7th day following surgery
Title
The presence or absence of alveolar osteitis
Description
The presence of a dry socket condition will be checked out at two time points.
Time Frame
This will be assessed on the 3rd and 7th day following surgery
Secondary Outcome Measure Information:
Title
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)
Title
Bone density and quality
Description
This will be assessed using Cone-beam computed tomography (CBCT) images. Hounsfield Units will be used to quantify bone density and quality.
Time Frame
at six months following surgery
Title
Change of bone healing status
Description
This will be assessed using panoramic radiographs
Time Frame
at 3 and six months following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuraldeen Al-Khanati, DDS
Organizational Affiliation
MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasser Al-Moudallal, DDS MSc PhD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School
Official's Role
Study Director
Facility Information:
Facility Name
Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
City
Damascus
State/Province
Damscus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22960208
Citation
Atrott J, Haberlau S, Henle T. Studies on the formation of methylglyoxal from dihydroxyacetone in Manuka (Leptospermum scoparium) honey. Carbohydr Res. 2012 Nov 1;361:7-11. doi: 10.1016/j.carres.2012.07.025. Epub 2012 Aug 8.
Results Reference
background
PubMed Identifier
18210383
Citation
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.
Results Reference
background
PubMed Identifier
22114404
Citation
Rathnam A, Madan N, Madan N. The language of pain: A short study. Contemp Clin Dent. 2010 Jul;1(3):142-5. doi: 10.4103/0976-237X.72778.
Results Reference
background
PubMed Identifier
11010778
Citation
Ruta DA, Bissias E, Ogston S, Ogden GR. Assessing health outcomes after extraction of third molars: the postoperative symptom severity (PoSSe) scale. Br J Oral Maxillofac Surg. 2000 Oct;38(5):480-7. doi: 10.1054/bjom.2000.0339.
Results Reference
background
PubMed Identifier
25298714
Citation
Singh V, Pal US, Singh R, Soni N. Honey a sweet approach to alveolar osteitis: A study. Natl J Maxillofac Surg. 2014 Jan;5(1):31-4. doi: 10.4103/0975-5950.140166.
Results Reference
background
PubMed Identifier
19648986
Citation
Wijesinghe M, Weatherall M, Perrin K, Beasley R. Honey in the treatment of burns: a systematic review and meta-analysis of its efficacy. N Z Med J. 2009 May 22;122(1295):47-60.
Results Reference
background
PubMed Identifier
24624197
Citation
Yaghoobi R, Kazerouni A, Kazerouni O. Evidence for Clinical Use of Honey in Wound Healing as an Anti-bacterial, Anti-inflammatory Anti-oxidant and Anti-viral Agent: A Review. Jundishapur J Nat Pharm Prod. 2013 Aug;8(3):100-4. doi: 10.17795/jjnpp-9487. Epub 2013 Jul 17.
Results Reference
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The Use of Manuka Honey to Improve Healing After Third Molars Surgery

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