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.: PACTR202310877678533 Date of Approval: 10/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of chemo-mechanical and conventional caries removal methods in children
Official scientific title Comparative evaluation of caries removal methods in 6-to-12-year-old children in Kano using chemo-mechanical agent and conventional rotary instrument.
Brief summary describing the background and objectives of the trial Dental caries is a major public health burden in most countries across the world, and it is the leading cause of tooth loss among the paediatric age group. The most popular method of caries removal is by drilling, using handpieces and burs (conventional method). In this method, all carious teeth are treated by elimination of both infected and affected dentine. Another method of caries removal is by the use of chemo-mechanical agents. These chemical agents not only selectively identify and remove infected dentine tissues but give a chance for remineralization of affected dentine hence, preserving healthy tissues. The fundamental drawback associated with the conventional caries removal method include, destruction of tooth structure, the need for local anaesthesia to control pain, sound generation and potential for spread of diseases. Consequently, this method causes unnecessary avoidance of dental visits and increasing concerns on the potential for spread of infections. This has led to the search for alternative methods. Chemo-mechanical caries removal (CMCR) is one such approach, viewed as less destructive, eco-friendly, and comfortable for anxious children. Both treatment methods have been reported as effective, hence the need to compare these two approaches, especially in light of the evolving trend towards minimally invasive procedure. objectives. To compare the effectiveness of CMCR and conventional drilling methods of caries removal using bacterial colony forming unit count. To compare the effectiveness of CMCR and conventional drilling methods of caries removal using caries detector dye. To compare how long it takes to remove caries when using the CMCR and conventional drilling methods. To compare the clinical retention and marginal leakage of restorations in teeth treated with CMCR and conventional drilling method.
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 03/01/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 33
Actual target sample size (number of participants) 33
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group caries removal method using chemomechanical agent Papacarie duo gel was used as the chemomechanical agent. until when the teeth are confirmed caries free using visual and tactile method. Teeth treated once The study was designed as a split mouth randomized clinical trial, consisting of 66 molar teeth selected from 33 healthy children. Thirty three teeth in this treatment arm had caries removal using chemo-mechanical method. Effectiveness of the treatment methods was assessed using ''total viable count'' before and after the treatment, as well as using caries detector dye. Time taken to carry out the caries removal was assessed and compared between the methods. The participants will have longitudinal clinical follow-up of the restorations done, where retention and marginal leakage will be assessed for a period of two years. 33
Control Group caries removal using conventional drilling method caries removal using conventional drilling method. caries removal was done and confirmed by visul and tactile method The study was designed as a split mouth randomized clinical trial, consisting of 66 molar teeth selected from 33 healthy children. thirty three teeth were treated using conventional method. Effectiveness of the caries removal was assessed by ''total viable plate count'' before and after the caries removal process. caries detector dye was also used to assessed effectiveness of caries removal. Time taken to complete caries removal was assessed using stop watch. Participants will have longitudinal clinical follow up of restoration for 2 years, where retention and maarginal leakage of the restoration will be assessed. 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children between the ages of 6 and 12 years (Mixed dentition stage). 2. Children who had at least two carious teeth with ICDAS score 4 or 5 on primary or permanent molars. 3. Children with Class I carious lesions (occlusal caries). 4. Children who gave their assent and whose parents consented to participate in the study. 1. Children who had teeth with clinical signs and symptoms of pulpitis, periodontitis, pulpal necrosis, fistula, or abscess. 2. Children with medical conditions, chronic illnesses or on long term medication. 3. Children with ICDAS score of 4 or 5 for a molar tooth that was mobile, unrestorable, or has arrested caries. 4. Children who had teeth with developmental anomalies such as molar incisor hypomineralization, dental fluorosis, taurodontism, germination, fusion etc. 5. Children with recurrent caries or failed restoration. 6. Highly uncooperative children. 7. Children whose primary molars were close to exfoliation as identified from the radiograph. Child: 6 Year-12 Year 6 Year(s) 12 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 03/09/2021 Aminu Kano Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zoo road, P.M.B. 3452 Kano 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effectiveness of caries removal using bacterial colony forming unit count/ ml within 24 hrs after sample collection/ treating the participants
Primary Outcome Effectiveness of caries removal using caries detector dye. At the point of treatment when caries removal was completed and confirmed using visual and tactile method of caries removal.
Primary Outcome caries removal time in seconds, using stop watch. At the point of treatment, from the time caries removal was started to when it was completed and confirmed.
Primary Outcome Clinical retention and marginal leakage of restorations in treated teeth. At one month, three months, six months, one year, and two years.
Secondary Outcome Subjective assessment of treatment preference of the participants. Immediately after treatment was completed
Secondary Outcome Pain and discomfort associated with the treatments. Immediately after treatment was completed
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Paediatric Dentistry clinic of Aminu Kano Teaching Teaching Hospital Kano State Zaria road, P.M.B. 3452 Kano State Nigeria 700233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Abdulrahman Bala Malami Zoo road, Kano Kano 700233 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Abdulrahman Bala Malami Zoo road, Kano Kano 700233 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulrahman Malami abmalami.cdh@buk.edu.ng +2348069661989 Zoo road, Kano
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Resident doctor
Role Name Email Phone Street address
Public Enquiries Okolo Chizoba chizokolo@gmail.com +2348060382775 Zoo road, Kano
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Consultant doctor
Role Name Email Phone Street address
Scientific Enquiries Yewande Adeyemo wendiepee@gmail.com +2348032223062 Zoo road, Kano
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Consultant doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: Data obtained from this study would be provided to qualified researchers with interest in dental caries management. Data shared will be coded with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan,Study Protocol Time Frame: Data requests can be submitted starting 7 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered. Access Criteria: ““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). For more information or to submit a request, please contact abmalami.cdh@buk.edu.ng
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