Clinical trial NCT02483741: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Extraction of Impacted Third Molars
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Levels of postoperative discomfort
timeFrame: 7 days after the surgical removal of third molars
measure: Change of facial contours due to swelling
timeFrame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
measure: Change of the masticatory muscles status
timeFrame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
measure: Pain and Change of pain
timeFrame: This will be assessed on the 3rd and 7th day following surgery
measure: The presence or absence of alveolar osteitis
timeFrame: This will be assessed on the 3rd and 7th day following surgery
Secondary outcomes:
measure: Time required to hemostasis
timeFrame: This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery)
measure: Bone density and quality
timeFrame: at six months following surgery
measure: Change of bone healing status
timeFrame: at 3 and six months following surgery
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
state: Damscus
Study officials:
affiliation: MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
name: Nuraldeen Al-Khanati, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School
name: Yasser Al-Moudallal, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.