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.: PACTR202407847952117 Date of Registration: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative evaluation of occlusal-splint and drug treatments in the management of temporomandibular disorders in a Northern Nigerian population
Official scientific title Comparative evaluation of occlusal-splint and drug treatments in the management of temporomandibular disorders in a Northern Nigerian population
Brief summary describing the background and objectives of the trial Temporomandibular disorders (TMD)s are ubiquitous derangements of the stomatognathic system characterized by a plethora of symptoms causing untold sufferings and a common cause of chronic orofacial pain. These disorders have been reported to have a peak incidence in middle age and among women, but various studies have reported varying patterns. The shortfalls arising from the effects of TMDs on affected individuals affect the individual and the community at large. There have been attempts to alleviate the symptoms using intra-oral devices, extra-oral physiotherapy, drug treatment and even psychological interventions. Two of these management modalities are: the application of occlusal-splint therapy which is instituted to reverse a physical cause for the disorder; drug therapy with analgesics and muscle relaxants to ameliorate pain associated with the disorder. The psychological aspects of this disorder have been tackled with psychotherapy in the form of cognitive behavioral therapy (CBT) to ameliorate a possible psychological cause. CBT is not usually used as a single treatment modality. While there have been several African studies on TMDs, the majority of these studies have not attempted to compare different treatment modalities, or propound a specific protocol based on the results of their findings. The study aims to compare outcomes of TMDs treated with splint therapy alone, drug therapy alone, splint therapy with CBT and drug therapy with CBT. Objectives: 1. To determine the relationship between sociodemographic parameters and pattern of TMD present in the participants 2. To determine the efficacy of each treatment modality in resolving TMD symptoms 3. To determine factors that may affect the efficacy and efficiency of each treatment regimen 4. To determine the effect size of each of the treatment regimens 5. To assess radiographic evidence of treatment efficacy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Musculoskeletal Diseases,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2024
Actual trial start date
Anticipated date of last follow up 31/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Drugs only 1. Tabs Norflex 100m.g. b.d. 2. Tabs Pcm 500m.g. t.d.s (prn) 14 days Analgesics and muscle relaxants for 14 days, all drugs will be converted to prn after 14 days if there are still any episodes of pain. 15 Active-Treatment of Control Group
Experimental Group Occlusal splints alone As much as possible but preferably overnight Three weeks An occlusal wax splint will fabricated for the individuals in the Splint experimental group which will be worn preferably overnight for three weeks 15
Experimental Group Drugs with Cognitive Behavioural Therapy Three weeks These therapies provide advice and instructions that enable patients to cope with the effects of chronic painful conditions. They prevent catastrophic feelings and feelings of resignation and promote a positive attitude towards the painful condition. This therapy also includes instructions that may lessen the chances of the development of painful episodes 15
Experimental Group Occlusal splints with Cognitive Behavioural Therapy Three weeks The combination of occlusal splints with combination of CBT instructions 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1. Potential participant must be at least 18 years old 2. Must have active symptoms at presentation 3. Must not have received any treatment for TMD in the past 2 months 4. Must be at least partially dentate with grossly stable occlusion of posterior teeth 5. Must not have radiographic evidence of occlusal trauma or derangement 1. Edentulous individuals 2. Individuals who wear partial dentures to obtain occlusion of posterior teeth 3. Individuals who have been treated for TMD within 2 months prior to presentation 4. Individuals who regularly take medication that may interfere with results e.g. painkillers, tranquilizers and muscle relaxants. 5. Individuals with radiographic evidence of occlusal trauma or derangement Adult: 19 Year-44 Year 18 Year(s) 44 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 19/12/2023 Aminu Kano Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zaria Road, Kano Kano 700225 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete resolution of symptoms Three weeks
Secondary Outcome Optimal occlusal correction and TMJ remodelling 8 weeks , 4 weeks post-intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road, Kano Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Aminu Kano Teaching Hospital Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self funded Zaria Road, Kano Kano Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
Adetayo Aborisade Zaria Road, Kano Kano Nigeria
Abdurazak Ajiya Zaria Road, Kano Kano Nigeria
Paul Ikhodaro Idon UNIMAID, Maiduguri Maiduguri Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwafeyisayo Francis IKUSIKA feyiikusika@yahoo.com +2347039294927 Zaria Road
City Postal code Country Position/Affiliation
Kano Nigeria Bayero University Kano.
Role Name Email Phone Street address
Public Enquiries Adetayo Aborisade adetayoaborisade@gmail.com +2348061976332 Zaria Road
City Postal code Country Position/Affiliation
Kano Nigeria Bayero University Kano.
Role Name Email Phone Street address
Scientific Enquiries Oluwafeyisayo Francis IKUSIKA feyiikusika@yahoo.com +234703929492 Zaria Road
City Postal code Country Position/Affiliation
Kano Nigeria Bayero Unversity Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared and made available, there is a plan to make IPD and related data dictionaries available and accessible. Data that will be shared include all de-identified information including participants' sociodemographic characteristics, diagnosis related information and type of interventions done. Statistical techniques and analysis results will also be made available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after study publication Data will be made available upon request to researchers who have IRB approval for their proposed studies and data will be made accessible via a data repository following data usage agreement
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