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Surgical Extraction of Impacted Third MolarsNCT02483741

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

A study testing Manuka Honey in people with Surgical Extraction of Impacted Third Molars, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 37 yearsHealthy volunteers can take part
What is being tested?
Manuka Honey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSyria
Study dates
Jun 2015to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 37 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

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

    Damascus, Damscus, DM20AM18

Other trials in Syria

About this study

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

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

Read the 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.

Being tested
Manuka Honey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manuka HoneyBiological

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

Study groups in NCT02483741
Study groupRoleWhat they receive
Manuka HoneyExperimentalManuka Honey will be placed in the sockets of the extracted third molars in this group
Receives: Biological: Manuka Honey
Traditional ExtractionNo interventionNo any special material will be placed in the sockets of the extracted third molars in this group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 days after the surgical removal of third molars

  2. 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.

    Measured: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.

  3. 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.

    Measured: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.

  4. Pain and Change of pain

    using a Visual Analog Scale of Faces (VASoF).

    Measured: This will be assessed on the 3rd and 7th day following surgery

  5. The presence or absence of alveolar osteitis

    The presence of a dry socket condition will be checked out at two time points.

    Measured: This will be assessed on the 3rd and 7th day following surgery

Secondary outcomes (3)

  1. Time required to hemostasis

    Measured: This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery)

  2. 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.

    Measured: at six months following surgery

  3. Change of bone healing status

    This will be assessed using panoramic radiographs

    Measured: at 3 and six months following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483741
Sponsor's protocol ID
UDDS-OMFS-04-2015
Status last verified
Dec 2016
First submitted
25 Jun 2015
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22960208

  • 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.

    PubMed 18210383

  • 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.

    PubMed 22114404

  • 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.

    PubMed 11010778

  • 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.

    PubMed 25298714

  • 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.

    PubMed 19648986

  • 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.

    PubMed 24624197

Questions about this trial

What is this clinical trial studying?

A study testing Manuka Honey in people with Surgical Extraction of Impacted Third Molars, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of postoperative discomfort (time frame: 7 days after the surgical removal of third molars). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02483741, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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