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.: PACTR201805003413788 Date of Approval: 23/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of the effectiveness of root canal therapy and pulpotomy for irreversible pulpitis in permanent teeth: A randomized controlled trial
Official scientific title A comparative evaluation of the effectiveness of root canal therapy and pulpotomy in treating irreversible pulpitis in mature permanent teeth
Brief summary describing the background and objectives of the trial Irreversible pulpitis (IP)is one of the most common complications of untreated dental caries and arguably the reason why patients seek treatment due to associated pain. Currently available care either leads to unnecessary tooth loss in large numbers, attendant functional and aesthetic issues or, huge treatment costs and possibly, overtreatment. Manpower and resource shortages also make contribute to making established treatment inaccessible to a significant proportion of affected people in Sub Saharan Africa. This indicates a need for an alternative treatment that eliminates pulpal disease, maintains teeth in the arch and is affordable and easy to perform with relatively lesser skills. Pulpotomy offers these advantages and may be a better treatment alternative. Indigenous studies on management of irreversible pulpitis with pulpotomy and comparison of pulpotomy with root canal therapy (RCT)in the management of IP are scarce. OBJECTIVES:To compare pre-operative and post-operative clinical features of teeth with irreversible pulpitis treated with RCT, calcium hydroxide pulpotomy or MTA pulpotomy. To compare radiographically, the pre-operative and post-operative appearances of teeth with irreversible pulpitis treated with RCT, calcium hydroxide pulpotomy or, MTA pulpotomy. To determine the influence of demographic, pre-operative and intra-operative variables on treatment outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Irreversible pulpitis,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 16/07/2018
Actual trial start date 27/11/2018
Anticipated date of last follow up 28/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Minimisation: Dynamic (adaptive) random allocation Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Root canal therapy Standard treatment for irreversible pulpitis 25 Active-Treatment of Control Group
Experimental Group Calcium hydroxide pulpotomy Experimental treatment for irreversible pulpitis (Vital Pulp Therapy) 25
Experimental Group Mineral Trioxide Aggregate Pulpotomy Experimental treatment for irreversible pulpitis (Vital Pulp Therapy) 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of irreversible pulpitis due to dental caries or defective restorations Positive response to electric and cold pulp sensitivity tests History of pain which may be any of the following: spontaneous, provoked (lasting a few seconds to several hours), not relieved by analgesics, disturbs sleep First or Second mandibular and maxillary molars Radiographic appearance of carious lesion closely approximating pulp or with pulp communication Patients who agree to sign a written informed consent to participate in the study Advanced periodontal disease Periodontic/endodontic lesions Tooth tender to percussion Tooth with non-vital/necrotic pulp evidenced by empty pulp space; no bleeding on entry into pulp chamber, or on amputation of coronal pulp; purulent pulp Traumatized tooth Periapical radiolucency Pulp calcification, obliteration of pulp chamber radiographically Grossly broken down (unrestorable) tooth Third molar More than one affected tooth per patient Medical conditions: diabetes mellitus, bleeding disorders, immune suppression Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 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 28/03/2018 Research Ethics Committee Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
2 Zaria road Kano 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical and radiographic success. Clinical success (absence of symptoms after intervention); radiographic success (normal radiographic appearance of periradicular region of treated tooth/teeth) 1 week after intervention 1 month after intervention 3 months after intervention 6 months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oral Diagnosis Clinic, Aminu Kano Teaching Hospital 2 Zaria road Kano 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Olusegun Alalade 2 Sambo street Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aminu Kano Teaching Hospital 2 Zaria road Kano 3452 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Ikusika O.F Restorative Clinic, Aminu Kano Teaching Hospital Kano 3452 Nigeria
Dr Bamise C.T Department of Restorative Dentistry, Obafemi Awolowo University Ile-Ife Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olusegun Alalade sadeolu@yahoo.com +2348032194138 2 Sambo street
City Postal code Country Position/Affiliation
Kano Nigeria
Role Name Email Phone Street address
Public Enquiries Oluwafeyisayo Ikusika feyiikusika@yahoo.com +234739294927 Restorative Clinic, Aminu Kano Teaching Hospital
City Postal code Country Position/Affiliation
Kano Nigeria Consultant/ Head of Department
Role Name Email Phone Street address
Scientific Enquiries Cornelius Bamise bamisect@yahoo.com +2348037115388 Department of Restorative Dentistry, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife Nigeria
REPORTING
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