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.: PACTR202310667867616 Date of Approval: 26/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative evaluation of efficacy of biodentine, mineral trioxide aggregate, calcium hydroxide and glass ionomer cement as pulp capping agent in deep carious lesions
Official scientific title Comparative evaluation of efficacy of biodentine, mineral trioxide aggregate, calcium hydroxide and glass ionomer cement as pulp capping agent in deep carious lesions
Brief summary describing the background and objectives of the trial The treatment of deep carious lesions (DCLs) aims mainly to maintain the affected dentin on the pulpal floor, and promote formation of new dentine, thus preserving the pulp vitality. Several pulp capping agents have been used with controversial outcomes, leaving clinicians to determine the most satisfactory agent in their practice. The purpose of this study was to clinically and radiographically compare and evaluate four types of indirect pulp capping (IPC) agents used in management of DCLs.
Type of trial CCT
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 10/07/2023
Actual trial start date 10/07/2023
Anticipated date of last follow up 04/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 205
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Indirect pulp capping with biodentine nil nil Biodentine (Septodont, St. Maur-des-Fossés, France) will be prepared according to the manufacturer's instructions for use. The liquid components will be added to the capsule, which will then be triturated for 30 seconds. The material, a malleable paste, will be applied in a layer over the thin dentin of the prepared tooth cavity with the supplied disposable small spatula to about 0.5 - 1mm thickness with light pressure application. Excesses will be removed with the spoon excavator and the biodentine placed on the dentine will be allowed to set for 12 minutes. 52
Control Group Indirect pulp capping with calcium hydroxide nil nil Ca(OH)2 (Dycal, Dentsply, Intl Inc. USA) base and catalyst paste of equal quantities will be mixed on paper pad into a smooth homogenous paste consistency. About 0.5 to 1mm thickness of the mixed paste will be placed carefully using a ball ended condenser on the base (floor) of the prepared cavity to follow the prepared cavity design, which for class II cavities will be the pulpal floor and pulpo-axial wall, and the pulpal floor in class I cavities. 52 Active-Treatment of Control Group
Experimental Group Indirect pulp capping using MTA nil nil MTA (Dentsply Tulsa Dental Specialties, Oklahoma, USA) powder and sterile water will be mixed on a glass slab in a 3:1 ratio to obtain a putty-like consistency. A 2-3mm thickness of the mix will be placed on the thin dentin of the prepared tooth cavity, followed by light pressure with moist cotton pellets for proper adaptation of the material to the dentin. When necessary the excess material will be removed using a spoon excavator. 51
Experimental Group Indirect pulp capping with GIC nil nil GIC (GC Fuji VII, GC cooperation Fuji, Tokyo, Japan) powder and liquid in the ratio of 1 level scoop of powder to 2 drops of liquid will be mixed on the supplied mixing paper pad for about 15-20 seconds, to obtain a viscous-like consistency. A 1-2 mm thickness of the material will be applied on the remaining sound dentine of the prepared tooth cavity- pulpal floor and/or pulpo-axial wall. This will be allowed to set for about 20-30 seconds. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All consenting adult subjects above 18 years of age, in good general health, presenting at the oral diagnosis and restorative dentistry clinics of UMTH. 2. Adults with at least one permanent molar are diagnosed to have an active DCL with or without irreversible pulpal damage or periapical involvement. 3. Any occlusal (G.V black class I) DCLs of at least 2/3rd depth or more into dentin thickness. 1. Subjects with DCLs with signs and symptoms of irreversible pulp inflammation or periapical inflammation. These include tooth/teeth with: a. Previous restorations b. History of related swelling c. Tenderness to palpation and/or percussion d. Grossly broken-down tooth e. Advanced periodontal diseases: grade III mobility f. The true negative response to pulp sensibility test g. Coronal radiolucency due to caries that is less than 2/3rd of the dentine thickness. h. Pulpal bleeding (exposure) during caries excavation i. Third molars. 2. Subjects with para-functional habits. 3. Subjects that have been on antibiotics or steroids six weeks prior to the study period. 4. Pregnant women. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 04/07/2023 ethics and research UMTH
Ethics Committee Address
Street address City Postal code Country
opposite bama road maiduguri pmb1414 Nigeria
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 04/07/2023 Reseach and ethics committee university of Maiduguri teaching hospital
Ethics Committee Address
Street address City Postal code Country
Bama road Maiduguri Maiduguri 1414 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain preoperatively and postoperatively, immediatelty, one week and six weeks.
Secondary Outcome radiographic thickness of residual dentine and new dentine formation 3months, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
maiduguri opposite bama road maiduguri pmb 1414 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self opposite bama road maiduguri pmb1414 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adamu Abdullahi Biu opposite bama road maiduguri pmb1414 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABDULLAHI ADAMU BIU abdullahiadamubiu29@gmail.com 2348036061715 department of restorative dentistry UMTH
City Postal code Country Position/Affiliation
MAIDUGURI 1414 Nigeria senior resident doctor
Role Name Email Phone Street address
Public Enquiries PAUL IDON idonp53@gmail.com +2348033890578 department of restorative dentistry university UMTH
City Postal code Country Position/Affiliation
Maiduguri 1414 Nigeria consultant restorative dentistry
Role Name Email Phone Street address
Scientific Enquiries OGINNI ADELEKE adelekeoginni@yahoo.co.uk +2348064459618 Road 7 hospital road
City Postal code Country Position/Affiliation
ILE IFE Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes, all data will be available after deidentification of the subjects Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately after publication, no yet date. opened data source
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