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.: PACTR202111738486539 Date of Approval: 18/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Evaluation of the efficacy of Chemomechanical (Papacarie) and Conventional Mechanical Caries Removal Methods in the Treatment of Carious Primary Molars: A Randomized Controlled Clinical Study
Official scientific title Comparative Evaluation of the efficacy of Chemomechanical (Papacarie) and Conventional Mechanical Caries Removal Methods in the Treatment of Carious Primary Molars: A Randomized Controlled Clinical Study
Brief summary describing the background and objectives of the trial BACKGROUND Dental caries is considered the most important oral public health problem. Conventional caries removal method involves the use of rotary instruments which is often associated with noise production that could induce fear in children and can cause discomfort in children. Research on caries management methods has led to minimal invasive methods like the Papacarie which is a chemomechanical caries removal agent. AIM: To compare the effectiveness of papacarie as a chemomechanical caries removal method with the use of mechanical method using rotary instruments. OBJECTIVES 1. To determine and compare the average time taken for caries removal in the chemomechanical (Papacarie) group and the conventional rotary group. 2. To determine and compare pain perception during caries removal in the chemomechanical (Papacarie) group and the conventional rotary group. 3. To determine and compare the viable bacterial count (Streptocoocus mutans) before and after use of the chemomechanical and the conventional method of caries removal
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 01/01/2022
Actual trial start date 30/05/2022
Anticipated date of last follow up 01/03/2022
Actual Last follow-up date 01/12/2022
Anticipated target sample size (number of participants) 23
Actual target sample size (number of participants) 25
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Papacarie group caries removal done before restoration of the tooth with glass ionomer cement caries removal on a carious primary molar done using papacarie gel 25
Control Group Rotary group caries removal done before restoring tooth with glass ionomer cement caries removal using low speed hand piece 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children in the age group of 5-9years. 2. Presence of at least 2 non pulpally involved carious lesion on the primary molar teeth confirmed by periapical radiographs. 3. Occlusal carious lesion of the dentine involving less than 2/3 of the dentine. 4. Children who are cooperative. 5. Children whose parent or guardian have given consent. 6. Children who have given their assent 1. Children with presence of debilitating medical conditions and or special needs 2. Teeth with clinical or radiographic signs and symptoms of pulpal involvement (spontaneous pain, abscess, fistula, periapical radiolucency, increase in periodontal ligament space, periapical radiolucency) 3. Teeth which have already been restored 4. Teeth with proximal carious lesions Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 9 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 21/06/2021 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi - araba Mushin, Lagos Nigeria Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effectiveness of chemomechanical caries removal method using papacarie compared with conventional mechanical caries removal using the dentine samples to measure the total bacteria count before and after caries removal method for each method and comparing them
Secondary Outcome acceptability of the chemomechanical caries removal method using papacarie compared with the conventional mechanical method using low speed handpiece using wong baker pain rating scale after completion of caries removal and calculation of caries removal time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL IDI- ARABA, MUSHIN LAGOS Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Christiansen professorship grant IA 52242 Iowa city United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akindele Bimbola 14 Segun Akinbuli street Ejigbo Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Olatosi Olubukola and Orenuga Omolola Lagos University Teaching Hospital, idi araba Mushin, Lagos. Mushin Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bimbola Akindele bimope10@yahoo.com +2348053138357 14 Segun Akinbuli street Ejigbo,
City Postal code Country Position/Affiliation
Lagos Nigeria senior registrar Lagos university teaching hospital
Role Name Email Phone Street address
Public Enquiries Bimbola Akindele bimope10@yahoo.com +2348053138357 14 Segun Akinbuli street Ejigbo
City Postal code Country Position/Affiliation
Lagos Nigeria senior registrar
Role Name Email Phone Street address
Scientific Enquiries Bimbola Akindele bimope10@yahoo.com +2348053138357 14 Segun Akinbuli street Ejigbo
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar Lagos university teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article after deidentification (tables, figures,text and appendices) will be available Study protocol will be available Data will be available to researchers who provide a methodologically sound proposal immediately after publication. No end date Proposals should be sent to bimope10@yahoo.com Study Protocol 12 months Not available yet
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