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.: PACTR202301888753718 Date of Approval: 17/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study on the effectiveness and safety of Azadirachta indica leaf extract versus chlorhexidine mouth rinses on postoperative complications following mandibular third molar surgeries: a randomized, double-blinded controlled study.
Official scientific title A comparative study on the effectiveness and safety of Azadirachta indica leaf extract versus chlorhexidine mouth rinses on postoperative complications following mandibular third molar surgeries: a randomized, double-blinded controlled study.
Brief summary describing the background and objectives of the trial The utilization of antimicrobial mouthrinses has been considered a useful adjunct to oral hygiene and effective in the control of complications following oral and periodontal surgeries. Several compounds have been evaluated for their antimicrobial effectiveness including bisbiguanides (such as chlorhexidine gluconate), and essential oils. Some of these substances are very expensive and unaffordable in a lower middle-income country like Nigeria and they also have been associated with side-effects that incapacitate their long-term use, and such new formulations are needed. Neem toothpastes and mouthwashes prevent cavities, heal gum diseases and rejuvenate the tissues of the mouth. Neem contains one of the strongest natural analgesics known, with results very apparent within few hours. The mechanism of its anti-inflammatory action is by inhibiting production of prostaglandin E and 5 HT. The antibacterial action can be explained by “Azadiachtin” that is known to destroy bacterial cell wall and thus inevitably inhibit the growth of bacteria. To the best of my knowledge, no randomized control trials have been done to assess the use of neem mouthwashes in oral and maxillofacial surgery despite showing promising results when used in other arears of dentistry. Hence, this study will be undertaken to come up with a novel and cost-effective neem mouthwash, to be used after third molar surgeries to reduce the occurrence of surgical complications. The effectiveness of this neem mouthwash will be compared with the already known two mouthwashes (chlorhexidine and warm saline). The aim of this research is to determine the effects of Azadirachta indica leaf extract and chlorhexidine on surgical outcomes in patients undergoing impacted mandibular third molar surgeries. Additionally, this paper will evaluate and compare their efficacy on pain, swelling, trismus, wound healing, alveolar osteitis and infection after surgical extraction of the impacted mandibular third molars.
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: Other
Anticipated trial start date 18/01/2023
Actual trial start date 18/01/2023
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Azadirachta Indica group 15ml of Azadirachta Indica mouthrinse administered twice in a day (morning and evening) 7 days All subjects in Azadirachta Indica (neem) group will receive verbal and written post-operative instructions and were given neem mouth rinse bottles that were prepared, based on the envelope number retrieved from the subjects. This will be done by a dental surgery assistant trained for the purpose. Azadirachta Indica (neem) solution will be locally produced. Rinse protocol will also be given. The patients will be expected to commence the mouthwash irrigation twice a day (morning and evening) starting from the day of surgery by pouring 15ml of the solution and then rinsing the mouth with it after leaving it for 60 seconds. This is to be repeated for day 1, 3 and 7. 21
Control Group Chlorhexidine group 15ml of chlorhexidine mouth rinse taken twice a day (morning and evening) 7 days All subjects in chlorhexidine group will receive verbal and written post-operative instructions and will be given chlorhexidine mouth rinse bottles that were prepared, based on the envelope number retrieved from the subjects. This will be done by a dental surgery assistant trained for the purpose. Chlorhexidine solution will be ordered from HealthPoint Nigeria Limited. Rinse protocol will also be given. The patients will be expected to commence the mouthwash irrigation twice a day (morning and evening) starting from the day of surgery by pouring 15ml of the solution and then rinsing the mouth with it after leaving it for 60 seconds. This is to be repeated for day 1, 3 and 7. 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age- 18-50 years. 2. Healthy patients (ASA I and II status). 3. Patients who did not use any antibiotic or anti-inflammatory agent 7 days prior to surgery. 4. Patients who understood the procedure and agreed to sign the informed consent form. 1. Patients with acute local infection at the operation site 2. Patients with systemic conditions like uncontrolled diabetes, uncontrolled hypertension, and blood dyscrasias. 3. Patients who were poorly motivated. 4. Patients whose duration of surgery exceeded 45 minutes 5. Patients whose dentition lacks natural opposing central incisors or prosthetic equivalent which would not allow standardization of the measurement of the maximum inter-incisal opening. 6. Patients on medications that might influence the surgical procedure or affect wound healing e.g., anticoagulants, and corticosteroids. 7. Patients with impacted third molars along a fracture line 8. Patients who were smokers. 9. Patient who are alcoholics 10. Patients who presented with impacted mandibular third molars assessed as ‘difficult’ using the Pederson Index. 11. Patients who had a history of head and neck cancer or radiotherapy. 12. Patients who were pregnant or lactating. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 21/11/2022 Ethics and Research Committee of the University of Benin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Lagos-Ugbowo Expressway Benin City 41120 NG Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative complications included the following signs and symptoms: alveolar infection; alveolar osteitis; trismus; pain (as assessed by a visual analog scale); and facial swelling as measured by the Laskin method. 0, 1, 3 and 7 postoperative days
Secondary Outcome Delayed wound healing using IPR Wound Healing Scale 0, 1, 3 and 7 postoperative days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Ugbowo-Lagos Expressway Benin city Nigeria
Edo State Specialist Hospital Sapele Road Benin City Nigeria
Delta State University Teaching Hospital Sakpoba/Otefe Road Oghara Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator UBTH Benin City Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Patience Ewere Ofiri 128 Airport Road Benin City Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dr. Ekaniyere Benlance Edetanlen ehiben2002@yahoo.com 08024223651 Ekosodin quarters
City Postal code Country Position/Affiliation
Benin City Nigeria Ugbowo
Role Name Email Phone Street address
Principal Investigator Patience Ewere Ofiri drewere@yahoo.com +2348023094531 128 Airport Road
City Postal code Country Position/Affiliation
Benin City Nigeria Ugbowo
Role Name Email Phone Street address
Public Enquiries Lawrence O. Igbinosa surglaw@yahoo.com +2348038101970 Lagos-Ugbowo Expressway
City Postal code Country Position/Affiliation
Benin City Nigeria Ugbowo
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes. Data obtained through this study may be provided to qualified researchers with academic interest in third molar surgeries. Data from samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are pre-requisites to the sharing of data with the requesting party. Statistical Analysis Plan Data requests can be submitted starting 9 months after article publication, and the data will be accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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