Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208644360490 Date of Approval: 15/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of honey after impacted third molar extraction
Official scientific title The effect of honey on postoperative sequelae and oral health-related quality of life after impacted mandibular third molar surgery: a randomized controlled study
Brief summary describing the background and objectives of the trial There are sufficient evidences which show that honey such as Manuka honey has anti-inflammatory effect. Therefore, this study is aimed at assessing the effect of Manuka honey on postoperative pain, swelling, trismus, and OHRQol following impacted mandibular third molar surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/01/2022
Actual trial start date 11/01/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 30/07/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 88
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group GROUP 2 7 days Following extraction, the extraction socket was allowed to fill with blood before suturing. 44 Uncontrolled
Experimental Group GROUP 1 5mls of Manuka honey 7 days following extraction of the third molar, 5mls of manuka honey was applied to the socket before suturing. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Symptomatic , Bilateral or unilateral Impacted Third Molars 18-45 years of age Uncontrolled diabetes, Hypersensitivity to Honey Alcoholism, Drug abuse, Tumor involving an impacted tooth Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2022 HEALTH RESEARCH ETHICS COMMITEE
Ethics Committee Address
Street address City Postal code Country
UGBOWO BENIN 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain, swelling, trismus, and OHRQol preoperative, day 1, day 3 and day 7
Secondary Outcome Duration of surgery and total analgesic consumption end of the surgery, day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF BENIN TEACHING HOSPITAL UGBOWO BENIN Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Oral and Maxillofacial surgery university of Benin Teaching Hospital Benin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. DANIEL EILUOJERIO DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, UNIVERSITY OF BENIN TEACHING HOSPITAL BENIN Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator DANIEL EILUOJERIO danjerio77@yahoo.com 07037006848 Department of oral and maxillofacial surgery, university of Benin teaching hospital
City Postal code Country Position/Affiliation
Benin Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries DANIEL EILUOJERIO danjerio77@yahoo.com 07037006848 Department of oral and maxillofacial surgery, university of Benin teaching hospital
City Postal code Country Position/Affiliation
Benin Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries DANIEL EILUOJERIO danjerio77@yahoo.com 07037006848 Department of oral and maxillofacial surgery, university of Benin teaching hospital
City Postal code Country Position/Affiliation
Benin Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared excluding the participants person identity information Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years following the completion of the study controlled accesss, all data analysis is allowed, access to researchers in the field of oral and maxillofacial surgery and related field will be allowed by taking permission from the principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information