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.: PACTR202001824413147 Date of Approval: 15/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of Platelet Rich Fibrin Regenerative Pulpotomy in Mature Permanent Molars with Irreversible Pulpitis
Official scientific title Evaluation of Platelet Rich Fibrin Regenerative Pulpotomy in Mature Permanent Molars with Irreversible Pulpitis (A RANDOMIZED CONTROLLED TRIAL)
Brief summary describing the background and objectives of the trial The aim of the present study is to assess the clinical and radiographic success of the regenerative pulpotomy procedure done in irreversibly inflamed permanent molars using Biodentine, Mineral trioxide aggregate (MTA), Platelet rich fibrin (PRF) + Biodentine, and Platelet rich fibrin + MTA.
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 01/06/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MTA Pulpotomy one time Followed up for 1 year 1) Removal of caries is done followed by access cavity preparation. 2) Homeostasis is achieved by using 2.5 % NaOCl. 3) MTA Pulpotomy is done for irreversibly inflamed permanent molars. 4) Final Restoration 12 Active-Treatment of Control Group
Experimental Group Biodentine Pulpotomy One time Followed up for 1 year 1) Removal of caries is done followed by access cavity preparation. 2) Homeostasis is achieved by using 2.5 % NaOCl. 3) Biodentine Pulpotomy is done for irreversibly inflamed permanent molars. 4) Final Restoration 12
Experimental Group PRF Pulpotomy capped by MTA One time Followed up for 1 year. 1) Removal of caries is done followed by access cavity preparation. 2) Homeostasis is achieved by using 2.5 % NaOCl. 3) PRF preparation 4) PRF is placed over the remaining radicular pulp then covered with MTA 5) Final Restoration 12
Experimental Group PRF Pulpotomy capped with Biodentine One time Followed up for 1 year 1) Removal of caries is done followed by access cavity preparation. 2) Homeostasis is achieved by using 2.5 % NaOCl. 3) PRF preparation 4) PRF is placed over the remaining radicular pulp then covered with Biodentine. 5) Final Restoration 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Male or female Patients with age ranging from 18 to 50 years old. 2) Patients complaining from intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain. 3) Patients’ selected teeth presented with fully developed roots. 4) Selected teeth should give positive responses to cold testing. 5) Selected teeth eliciting prolonged episodes of pain on rapid exposure to dramatic temperature changes and lasting even after the thermal stimulus had been removed. 6) Periapical radiographs showed deep carious lesions. 7) Soft tissues around the tooth were normal. 8) The patients were free from any coagulation disorders, with normal platelets count. 1) Badly broken or non-restorable teeth. 2) Patients with multiple teeth seeking root canal treatment in the same side. 3) Teeth with Pathological mobility. 4) Pus discharge through an associated sinus tract. 5) Radiographic internal or external resorption or furcation radiolucency. 6) Medically compromised patients. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 23/04/2018 The research ethics committee faculty of dentistry alexandria university
Ethics Committee Address
Street address City Postal code Country
champilion street alexandria 21514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of the present study is to assess the clinical and radiographic success rate of the regenerative pulpotomy procedure done in irreversibly inflamed permanent mature teeth using: a) Biodentine. b) Mineral trioxide aggregate (MTA). c) Platelet rich fibrin (PRF) and Biodentine. d) Platelet rich fibrin and Mineral trioxide aggregate. at 1, 3, 6 and 12 months
Secondary Outcome CBCT analysis is done immediate post-operative and at the end of the follow up period At the end of the follow up period after 1 year
Secondary Outcome is to evaluate the ability of PRF membrane to regenerate the coronal pulp and maintaining the tooth vitality using pulse oximetry. at 3,6 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of dentistry Alexandria University Champilion Street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mobarak husein sheren street Alexandria 21511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Conservative Dentistry Faculty of Dentistry Alexandria University champilion street Alexandria 21514 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mobarak husein sheren street Alexandria 21511 Egypt
Sybel Moussa Fouad Street Alexandria 21514 Egypt
Salma Genena abdelmonem el dalil Alexandria 21511 Egypt
Ashraf Zaazou Sharawy street Alexandria Egypt
Nayera Mokhles San Stefano Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Sybel Moussa sybel_moussa@yahoo.com +201223409497 Fouad Street
City Postal code Country Position/Affiliation
alexandria 21514 Egypt Professor of Endodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Principal Investigator Ahmed Mobarak ahmed.mobarak@icloud.com +201203968888 husein sheren street
City Postal code Country Position/Affiliation
alexandria 21511 Egypt Assistant lecturer of Endodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Salma Genena salmagenena2@gmail.com +201210188458 abdelmonem el dalil
City Postal code Country Position/Affiliation
alexandria 21511 Egypt Lecturer of Endodontics faculty of Dentistry Alexandria University.
Role Name Email Phone Street address
Public Enquiries Ashraf Zaazou ashrafzaazou@hotmail.com +201223326647 sharawy street
City Postal code Country Position/Affiliation
alexandria Egypt Professor of Endodontics Faculty of Dentistry Alexandria university
Role Name Email Phone Street address
Public Enquiries Nayera Mokhles nayeramokhless@hotmail.com +201225568688 san stefano
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Endodontics Faculty of Dentistry Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes it would provide summery results to allow re analyse trial data, enabling combining trial data with other data for novel investigator Clinical Study Report,Informed Consent Form within 12 months of the study completion date. controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none 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