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.: PACTR201901866476410 Date of Approval: 30/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of The Regenerative Potential of a Novel Treated Dentin Matrix Hydrogel and Bioactive Dentin Substitute in Direct Pulp Capping
Official scientific title Clinical And Histological Evaluation of The Regenerative Potential of a Novel Treated Dentin Matrix Hydrogel and Bioactive Dentin Substitute in Direct Pulp Capping (A Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial Biodentine is a new bioactive calcium silicate-based cement known as “bioactive dentin substitute” with dentin-like mechanical properties. MTA has been investigated in various human and animal experimental models. On the other hand, studies comparing MTA with Biodentine in terms of vital pulp treatment behavior are rather limited. Regenerating dentin and preserving pulp vitality are the two key targets for the treatment of dental pulp exposure. In view of the increasing demand for maintaining dentin-pulp complex vitality, there has been increasing interest in investigating new methods for tissue replacement. Treated dentin matrix (TDM) has recently been shown to be a suitable scaffold for human dentin regeneration because of its high bioinductive properties. However, the TDM has less physical stability and sealing ability as a pulp capping material. Therefore, TDM will be further fabricated into TDM hydrogel as an injectable scaffold. A novel TDM hydrogel is composed of TDM powder and sodium alginate as an anionic natural polymer typically extracted from brown seaweeds. The aim of the present study is to assess the clinical and radiographic success of the direct pulp capping procedure done in traumatically exposed permanent posterior teeth using Treated dentin matrix hydrogel (TDMH), Biodentine and Mineral trioxide aggregate (MTA), and to study histologically the pulpal response to these pulp capping materials in sound premolars scheduled to be extracted for orthodontic reasons.
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: Devices
Anticipated trial start date 15/02/2019
Actual trial start date 15/02/2019
Anticipated date of last follow up 15/08/2010
Actual Last follow-up date 15/08/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Not yet 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 Permuted block randomization 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 Treated dentin matrix hydrogel TDMH 1.5 YEARS TDM hydrogel will be prepared by mixing TDM powder with the prepared alginate corresponding to maximum amount of TDM powder that will allow the formation of injectable formulations 15
Experimental Group Biodentine 1.5 YEARS Exposed pulp will be capped with Biodentine per manufacturer’s recommendations. The freshly mixed cement will be carried with a small size amalgam carrier and applied over the exposed pulp and gently condensed using a small amalgam condenser. 15
Control Group MTA 1.5 YEARS MTA will be prepared by gradually mixing 1 mg powder with the liquid within 1 minute according to the manufacturer’s instructions until a thick paste with creamy consistency will be obtained. Freshly mixed MTA will be applied over the exposed pulp using an applicator and gently condensed using a small amalgam condenser 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Clinically diagnosed carious permanent posterior teeth with accidental traumatic pulp exposures and without any periapical pathology. - Exposures with controllable light red bleeding and within an estimated size of 1 mm2 will be considered. - No history of spontaneous pain in response to temperature or biting. - Soft tissues around the tooth are normal. - The patient with good oral hygiene. - The patient has non-contributory medical history. - The treated teeth will not be used as abutments for fixed or removable partial dentures. - Teeth with pathological exposures. - Teeth with exposures with excessive uncontrollable bleeding. - Non-restorable tooth. - Teeth having subgingival margins. - Teeth that have not erupted sufficiently to allow isolation with rubber dam. - Teeth with pathological mobility. - Swelling of associated tissues. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 23/10/2018 IRB Faculty of Denistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champlion Street Raml Station Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical and radiographic success of direct pulp capping procedure done in traumatically exposed permanent posteriduring cavity preparation using TDMH, Biodentine and MTA 1, 3, 6, 12 and 18 months
Secondary Outcome Histological evaluation of pulpal response after direct pulp capping procedure in premolars scheduled to be extracted for orthodontic reasons using TDMH, Biodentine and MTA. After 2 weeks and 2 months intervals, the teeth will be extracted and subjected to histological analysis using hematoxylin-eosin stain.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Conservative Dentistry Faculty of Dentistry Alexandria University Champlion street, Raml Station., Alexandria Egypt Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Holiel Champlion Street, Azarita Alexandria 21521 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 Champilon street, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
El sayed Moustafa Mahmoud Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Wegdan Mohamed AbdelFattah Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Khadiga Youssef Kawana Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Ahmed Holiel Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Mahmoud elsayedmostafa945@gmail.com 00201001634253 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Conservative Dentistry Conservative Dentistry Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Wegdan AbdelFattah Wegdan_f@yahoo.com 00201223932687 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Conservative Dentistry Conservative Dentistry Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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