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.: PACTR202308547851267 Date of Approval: 08/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the effects of three agents used in the treatment of disease of the pulp in permanent posterior teeth in the Nigerian adult population
Official scientific title A comparative evaluation of three indirect pulp capping agents in the treatment of reversible pulpitis in permanent posterior teeth in Nigerian adult patient
Brief summary describing the background and objectives of the trial Reversible pulpitis from deep carious lesion is a common disease entity in Dentistry worldwide. Indirect pulp capping is the recommended treatment. Calcium hydroxide has been the most common agent used in our environment. Newer agents are being developed and domesticated in other countries. It will be worthwhile to evaluate the newer agents against the commonly used in our environment. The study's objectives include 1. To compare the clinical outcomes after treatment with calcium hydroxide, Mineral trioxide aggregate and Biodentine 2. To compare the radiological outcomes following successful clinical outcomes with the same agents 3. To compare the effects of age , gender and site of carious lesion on clinical outcomes
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IPCAPPTNAP
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/08/2019
Actual trial start date 14/07/2021
Anticipated date of last follow up 10/10/2022
Actual Last follow-up date 19/12/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 156
Recruitment status Completed
Publication URL Nil
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A or calcium hydroxide group A 1mm layer of Calcium hydroxide cement was applied on the floor of the prepared cavity once throughout the study Once throughout the duration of the study After routine local anaesthesia administration, rubber dam isolation,and cavity preparation, Calcium hydroxide cement was mixed on a platform and subsequently transferred to the cavity floor with ball burnisher. When set, the lining was adjusted to attain a thickness of 1mm. A 1mm protective base of Glass ionomer cement was applied over the lining. The rest of the cavity was restored with composite resin 52 Active-Treatment of Control Group
Experimental Group Group B or Mineral trioxide aggregate group 2mm layer of Mineral trioxide aggregate, applied only once through the period of the period of study Once throughout the duration of the study After routine anaesthesia, isolation and cavity preparation, Mineral trioxide aggregate cement was mixed on a platform and transferred to the cavity floor. When set, it was adjusted to a thickness of 2mm and the rest of the cavity was restored composite resin 52
Experimental Group Group C or Biodentine group 2mm layer of Biodentine cement applied once throughout the duration of the study Once throughout the duration of the study After routine anaesthesia, isolation and cavity preparation, Biodentine was triturated and applied onto the floor of the cavity. When set, it was adjusted to a thickness of 2mm and the rest of the cavity was restored with composite resin 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Individuals who are eighteen years and above 2. Premolar and(or) molar teeth with active deep carious lesions of GV Black Class I or II configurations 3. Teeth with the above characteristics with mild provoked intermittent pain 4. Teeth with positive electric and cold thermal sensibility test that ceased within fifteen seconds of removal of stimulation 5. Teeth with radiographic evidence of carious lesion extension into the pulpal quarter of the dentine thickness without pulpal communication 6. Teeth with periapical index of two or less 7. Teeth from individuals with the above characteristics who had not consumed any antibiotics within the preceding two months to recruitment 1. Teeth with arrested carious lesions 2. Teeth with advanced periodontal disease or periodontal-endodontic lesions 3. Teeth with radiographic evidence of periapical pathology or partial or complete pulpal obliteration 4. Unrestorable or grossly broken teeth with reversible pulpitis 5. Teeth with signs and symptoms of irreversible pulpitis , acute or chronic apical periodontitis 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 30/09/2019 Aminu Kano Teaching Hospital ethics committee
Ethics Committee Address
Street address City Postal code Country
1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical outcome by conducting sensibility test, periapical palpation test, percussion test, mobility test and denoting the presence or absence of pain at 1,3, and 6 months post-operative period. Radiological outcome were determined by measuring the thickness of reparative dentine formed at 3 and 6 months Clinical outcomes were measured at 1, 3 and 6 months post-treatment whereas the radiological outcome were measured at 3, and 6 months post-treatment for only teeth with clinical successes
Secondary Outcome The influence of age, gender and site of carious lesion on treatment outcome 1,3, and 6 month post-operative periods
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Igweagu Chibuzor Emmanuel 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Igweagu Chibuzor Emmanuel 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ikusika Feyi Xavier 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
Sotunde Akeem Olawale 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
Prof. Bamgbose Babatunde 1,2 Zaria road, Tarauni Local Government Area Kano Metropolitan PMB 3452 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chibuzor Igweagu cigweagu@gmail.com 2348023019448 1,2 Zaria road, Tarauni Local Government Area
City Postal code Country Position/Affiliation
Kano Metropolitan PMB 3452 Nigeria Head
Role Name Email Phone Street address
Public Enquiries Chibuzor Igweagu cigweagu@gmail.com 2348023019448 1,2 Zaria road, Tarauni Local Government Area
City Postal code Country Position/Affiliation
Kano Metropolitan PMB 3452 Nigeria Head
Role Name Email Phone Street address
Scientific Enquiries Chibuzor Igweagu cigweagu@gmail.com 2348023019448 1,2 Zaria road, Tarauni Local Government Area
City Postal code Country Position/Affiliation
Kano Metropolitan PMB 3452 Nigeria Head
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial , after de-identification, will be available beginning 6 months and ending 36 months following article publication. The data will be made available to researchers interested in the field of Reversible pulpitis who provided a methodological sound proposal. Proposal should be directed to cigweagu@gmail.com. To gain access, interested researchers will need to sign a data access agreement. Data will be made available or 3 years at third party website with link included. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data request can be submitted stating from 6 months after article publication and the data will be made accessible for up to 36 months. Extension of this window period will be considered on a case-to-case basis Access to IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of research proposal and statistical analysis plan and execution of a data sharing agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/drive/folders/1pjE8XRme0xyktGIDZOvbPvkdkRqTQAsw?usp=sharing Yes 05/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/08/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/drive/folders/1pjE8XRme0xyktGIDZOvbPvkdkRqTQAsw?usp=sharing
Changes to trial information