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.: PACTR202602730574713 Date of Registration: 26/02/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital
Official scientific title Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital
Brief summary describing the background and objectives of the trial Symptomatic irreversible pulpitis (SIP) is a leading cause of severe dental pain and emergency dental visits, particularly in low- and middle-income countries where delayed presentation and limited access to specialist endodontic care are common. Root canal therapy (RCT) is traditionally considered the gold standard for managing mature permanent teeth with SIP. However, RCT is technique-sensitive, time-consuming, and relatively expensive, and it involves the complete removal of the dental pulp, resulting in loss of tooth vitality. These limitations reduce its accessibility in resource-constrained settings. Emerging evidence indicates that, in many cases clinically diagnosed as irreversible pulpitis, inflammation may be limited to the coronal pulp, leaving the radicular pulp potentially viable. This has renewed interest in pulpotomy as a biologically conservative alternative aimed at preserving pulp vitality. Mineral Trioxide Aggregate (MTA) is widely regarded as the gold standard material for pulpotomy due to its biocompatibility and bioactivity. However, drawbacks such as prolonged setting time, handling difficulties, possible tooth discolouration, and cost have led to the development of newer calcium silicate-based materials such as Biodentine (BD), which offers improved handling and faster setting time. Direct comparative evidence between BD and MTA in mature permanent teeth with SIP, particularly in African populations, remains limited. This randomised clinical trial aims to compare the clinical and radiographic effectiveness of BD and MTA for pulpotomy in mature permanent mandibular molars with SIP. Outcomes include postoperative pain, analgesic consumption, and clinical and radiographic success over a 6-month follow-up period.
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: Drugs
Anticipated trial start date 16/02/2026
Actual trial start date
Anticipated date of last follow up 26/10/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UMTHREC2533 University of Maiduguri Teaching Hospital Ethics Committee
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Biodentine Approximately 2–3 mm thickness placed directly over the radicular pulp stump after complete coronal pulp amputation and haemostasis. Mixed and applied according to manufacturer’s instructions. Permanent placement as part of definitive restoration. Biodentine (Septodont, Saint-Maur-des-Fossés, France) is a bioactive calcium silicate–based cement developed as a dentine substitute and pulp-capping material. It primarily contains tricalcium silicate, dicalcium silicate, calcium carbonate, and zirconium oxide (as a radiopacifier). When mixed, it undergoes a hydration reaction that produces calcium silicate hydrate gel and calcium hydroxide, resulting in an alkaline environment that supports antibacterial activity and pulp healing. Biodentine promotes the formation of reparative dentine by stimulating odontoblastic activity and mineralised tissue deposition. It provides good marginal sealing ability, biocompatibility, and bioactivity. Compared to Mineral Trioxide Aggregate (MTA), Biodentine has a shorter setting time (approximately 12 minutes), improved handling characteristics, and minimal risk of tooth discolouration. 38
Control Group Mineral Trioxide Aggregate Approximately 2–3 mm thickness placed directly over the radicular pulp stump after complete coronal pulp amputation and haemostasis. Mixed and applied according to manufacturer’s instructions. Permanent placement as part of definitive restoration. Mineral Trioxide Aggregate (ProRoot MTA, Dentsply Tulsa Dental Specialties, USA) is a calcium silicate–based bioactive cement widely regarded as the gold standard material for vital pulp therapy. It is primarily composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, and bismuth oxide (for radiopacity). Upon hydration, MTA forms calcium silicate hydrate gel and releases calcium hydroxide, creating a high pH environment that contributes to antimicrobial activity and stimulation of hard tissue formation. MTA is highly biocompatible and exhibits excellent sealing ability, which supports dentine bridge formation and long-term pulp vitality preservation. However, it has certain clinical limitations, including prolonged setting time, handling difficulty, higher cost, and potential for tooth discolouration. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults aged 18 years and above with no known systemic medical conditions, who provide informed written consent to participate in the study. 2. Moderate-to-severe pain, symptomatic irreversible pulpitis, in a mature mandibular molar diagnosed with irreversible pulpitis secondary to caries. 3. SIP symptoms characterised by spontaneous, referred, or nocturnal pain, along with a pronounced, lingering response (over 30 seconds) to cold testing,10 using Endo-Frost (Coltene Whaledent, Altstatten, Switzerland). Participants must score at least 4 on a Visual Analogue Scale (VAS) for pain assessment. 4. Radiographic examination must show a periapical index (PAI) of less than or equal to 2. 5. Teeth with visible bleeding pulp upon accessing the pulp chamber. 6. If haemostasis is achieved within 10 minutes after coronal pulp amputation. 1. Patients who do not give informed consent to participate in the study. 2. Patients below 18 years or geriatric patients (above the age of 65 years). 3. Patients with systemic conditions that could affect healing (e.g., diabetes, immunocompromised states). 4. Patients currently taking medications that could influence pain perception or healing (e.g., long-term steroid use). 5. Periapical index (PAI) greater than 2. 6. Teeth with mobility, associated sinus tracts, necrotic pulp (indicated by negative response to pulp testing, or lack of bleeding in the pulp chamber), or teeth that cannot be restored. 7. Presence of significant radiolucency in the furcation area and any evidence of internal or external root resorption, calcifications, or pulp canal obstructions. 8. If haemostasis of the pulp stump cannot be achieved within 10 minutes after coronal pulp amputation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 28/04/2025 University of Maiduguri Teaching Hospital Ethics Commottee
Ethics Committee Address
Street address City Postal code Country
Bama Road, Maiduguri, Nigeria Maiduguri 600004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical and radiographic success of pulpotomy 6 months post-intervention
Secondary Outcome Postoperative pain intensity Daily for 7 days post-intervention
Secondary Outcome Analgesic consumption Within 7 days post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri teaching Hospital Bama Road, Maiduguri, Nigeria Maiduguri 600004 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Samaila Stanley No5 Ali Kotoko Street Opp FHI 360 Office Maiduguri Maiduguri 600004 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Samaila Stanley No. 5 Ali kotoko Street Opp. FHI 360 Maiduguri Maiduguri 600004 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samaila Stanley stansaqm@gmail.com +2348135722979 No. 5 Ali kotoko Street Opp. FHI 360
City Postal code Country Position/Affiliation
Maiduguri 600004 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Samaila Stanley stansaqm@gmail.com +2348135722979 No. 5 Ali Kotoko Street Opp. FHI 360
City Postal code Country Position/Affiliation
Maiduguri 600004 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Paul I. Idon idonp85@gmail.com +2348033890578 Bama Road
City Postal code Country Position/Affiliation
Maiduguri 600004 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study (including pain scores, analgesic consumption, and clinical and radiographic outcome data) will be made available upon reasonable request to the corresponding investigator. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be shared after publication of the primary results and will be accessible for up to 5 years following publication. Requests will require a methodologically sound proposal and approval by the institutional ethics committee.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 19/02/2026 To ensure that the public title is not in capital letters only COMPARATIVE EVALUATION OF BIODENTINE AND MINERAL TRIOXIDE AGGREGATE FOR PULPOTOMIES IN MATURE PERMANENT TEETH WITH IRREVERSIBLE PULPITIS: A RANDOMISED CLINICAL TRIAL AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 19/02/2026 To ensure that the scientific title is not in capital letters only COMPARATIVE EVALUATION OF BIODENTINE AND MINERAL TRIOXIDE AGGREGATE FOR PULPOTOMIES IN MATURE PERMANENT TEETH WITH IRREVERSIBLE PULPITIS: A RANDOMISED CLINICAL TRIAL AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 19/02/2026 To ensure that all the applicable age groups have been ticked. Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/02/2026 It was a mistake. Now Updated. The phone number has been updated too, to that of the committee. TRUE, University of Maiduguri Teaching Hospital Ethics Commottee, Bama Road, Maiduguri, Nigeria, Maiduguri, 600004, Nigeria, , 28 Apr 2025, +2349055391767, stansaqm@gmail.com, 40927_38114_4737.pdf TRUE, University of Maiduguri Teaching Hospital Ethics Commottee, Bama Road, Maiduguri, Nigeria, Maiduguri, 600004, Nigeria, , 28 Apr 2025, +2348038087639, cmd_umth@yahoo.com, 40927_38114_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 19/02/2026 To ensure that the source name is an actual name, in this case, the name of the Principal Investigator. Self, No5 Ali Kotoko Street Opp FHI 360 Office Maiduguri, Maiduguri, 600004, Nigeria, Self Funded, Samaila Stanley, No5 Ali Kotoko Street Opp FHI 360 Office Maiduguri, Maiduguri, 600004, Nigeria, Self Funded,