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.: PACTR202205478844180 Date of Registration: 18/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effects of kinesiology taping, submucosal dexamethasone and serratiopeptidase on post-operative inflammatory sequelae after mandibular third molar surgery- a randomized study
Official scientific title The effects of kinesiology taping, submucosal dexamethasone and serratiopeptidase on post-operative inflammatory sequelae after mandibular third molar surgery- a randomized study
Brief summary describing the background and objectives of the trial Background: The extraction of the impacted mandibular third molar is one of the most frequently encountered procedures in maxillofacial surgery. Postoperative inflammatory sequelae, such as pain, swelling and trismus arise from the surgical manipulation of both hard and soft tissue around the impacted tooth, thus adversely affecting patient’s quality of life especially in the early postoperative days. Objective: To compare the effects of kinesiology tape, submucosal injection of dexamethasone and serratiopeptidase in reducing post-operative pain, swelling and trismus and improving quality of life following impacted mandibular third molar extraction. Methodology: 87 healthy participants will be recruited and randomized into three treatment groups using simple randomization: Kinesiology taping (group A), Submucosal dexamethasone (group B), and serratiopeptidase (group C). For participants in group A, kinesiology tape will be applied by a physiotherapist immediately after surgical procedure and will remain in place for 5 days. Participants in group B will receive 8mg of dexamethasone applied submucosally in the buccal sulcus near the surgical site, 10 minutes prior to the commencement of surgical procedure. Participants in third group will receive 5mg of serratiopeptidase tablet taken per oral 8 hourly for three days. Medication will be commenced immediately after the surgical procedure. Post-operative data will include pain evaluation using visual analogue scale (VAS), facial measurement using a plastic measuring tape and assessment of maximum interincisal distance using a Vernier calliper. These data will be collected on 1st, 3rd and 7th post-operative days for all participants in the three treatment groups. The quality of life (Qol) will be assessed using the postoperative symptoms severity scale (PoSSe) on the 7th post-operative day for all participants in the three treatment groups. Data Analysis: Paired t test or its non-parametric version will be used to compare temporal changes in the outcome parameters in each group. Repeated measures Analysis of Variance (ANOVA) will be used to compare pain, swelling, mouth opening and quality of life across the three arms of the intervention. Statistical significance will be inferred at p< 0.05.
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: Surgery
Anticipated trial start date 16/05/2022
Actual trial start date
Anticipated date of last follow up 13/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 87
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Serratiopeptidase 5mg per oral 8 hourly Three days 5mg of serratiopeptidase tablet taken per oral 8 hourly for three days. Patients will commence medication immediately after the surgical procedure. 29
Experimental Group Kinesiology Taping Five days Kinesiology tape will be applied using the method described by Erdil et al. This shall be done by a physiotherapist who is skilled at application. Taping will be done immediately after surgical procedure and will remain in place for 5 days following surgery. 29
Experimental Group Submucosal dexamethasone 8mg Stat dose 8mg of dexamethasone applied submucosally in the buccal sulcus near the surgical site, 10 minutes prior to the commencement of surgical procedure . 29
Control Group Not used Not applicable Not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Consenting patients whose ages shall be between 18 to 40 years and shall be willing to return for follow-up visits. 2. Patients with impaction of mandibular third molars that belong to Pell and Gregory Class IIA and B diagnosed using preoperative periapical radiographs. 3. Patients with no history of allergies to dexamethasone and serratiopeptidase. 4. Patients that are free of clinical evidence of infection and without pericoronal inflammation around mandibular third molars. 5. American society of Anaesthesiologist I (ASA I) health status. 1. Patients who do not consent after being fully informed about the study. 2. Patients with chronic systemic diseases such as diabetes mellitus, hepatic or renal diseases. 3. Pregnant or lactating patients. 4. Patients with bleeding disorders or who are on anticoagulant therapy. 5. Patients with acute viral, fungal or bacterial infections. 6. Patients with missing upper or lower central incisors. 7. Patients with long-term use of medications that would obscure assessment of the inflammatory response such as patients on immunosuppressants. 8. Mentally unstable patients with past or present history of psychiatric illness. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 40 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 14/10/2021 Ethics Committee of the Obafemi Awolowo University Teaching Hospital Ile Ife.
Ethics Committee Address
Street address City Postal code Country
Ilesha Road Ile Ife Ile Ife 220101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Preoperatively and Postoperative days 1,3, and 7
Secondary Outcome Facial swelling Preoperatively and Postoperatively at days 1, 3, and 7.
Secondary Outcome Trismus Preoperatively and Postoperatively at days 1, 3, and 7.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ile Ife. Ilesha Road, Ile Ife. Ile Ife 220101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adeyemi Adewale Charles 19, Aladanla line 1, Ile-Ife Ile Ife 220101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adeyemi Adewale Charles Aladanla Ile Ife Ile Ife 220101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Fasote Emmanuel 16, Oke- Opa Ile - Ife Ile Ife 220101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adewale Adeyemi Adedecha22@yahoo.com +2348066652082 Aladanla Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Babatunde Aregbesola tttaregs@yahoo.com +2348067033931 Kojumole Street, Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Adewale Adeyemi Adedecha22@yahoo.com +2348066652082 Aladanla Street Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data shall include sex, age (last birthday), height (m), Weight (kg), Ethnicity, Occupation, Indication for extraction, type of impaction, Pederson score, duration of surgery, volume of local anesthetic used. Informed Consent Form within 12 months of trial completion Request shall be controlled, process for requesting data shall be done by contacting the principal investigator, data analysis is open, criteria for reviewing requests shall be based on quality of request.
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