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

NCT02483741 | Completed DMC

• 1 other identifier: UDDS-OMFS-04-2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Extraction of Impacted Third Molars

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

• Change of bone healing status

  at 3 and six months following surgery

Study Arms (2)

Manuka Honey

EXPERIMENTAL

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

Biological: Manuka Honey

Traditional Extraction

NO INTERVENTION

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

Interventions

Manuka Honey BIOLOGICAL

This material is going to be placed into the sockets of the extracted third molars in the experimental group

Manuka Honey

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, Damscus, DM20AM18, Syria

Location

Related Publications (7)

• 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.

  PMID: 22960208 BACKGROUND

• 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.

  PMID: 18210383 BACKGROUND

• 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.

  PMID: 22114404 BACKGROUND

• 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.

  PMID: 11010778 BACKGROUND

• 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.

  PMID: 25298714 BACKGROUND

• 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.

  PMID: 19648986 BACKGROUND

• 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.

  PMID: 24624197 BACKGROUND

Study Officials

• Nuraldeen Al-Khanati, DDS

  MSc student, Oral and Maxillofacial Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Yasser Al-Moudallal, DDS MSc PhD

  Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)