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Trial registered on ANZCTR


Registration number
ACTRN12621001219875
Ethics application status
Approved
Date submitted
27/08/2020
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regenerative endodontic procedures for non-vital mature teeth.
Scientific title
A comparative study of the use of Biphasic Calcium Phosphate (BCP) as a scaffold and Bioceramic root repair material (BC-RRM) for coronal sealing with blood clot and Mineral Trioxide Aggregate (MTA) in pulp regeneration of non-vital mature teeth; clinically and radiologically.
Secondary ID [1] 302155 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-vital mature teeth. 318798 0
Condition category
Condition code
Oral and Gastrointestinal 316814 316814 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinical study will conduct on a sample of 40 adult patients in each patient with a non vital mature tooth. The sample will divide into 4 subgroups (10 in each group):
Biphasic Calcium Phosphate (BCP) scaffold and Bioceramic RRM, arm 1
Biphasic Calcium Phosphate (BCP) scaffold and MTA, arm 2
Blood clot scaffold and Bioceramic RRM, arm 3
Blood clot scaffold and MTA, arm 4
The canals will be prepared and the apical foramen will be enlarged to 0.60 mm, after that: Double Antimicrobial Paste (DAP) will be applied for a period of 3 weeks then it will be removed, then the induction of bleeding by bypassing the apex will be confirmed using 15 k-file and waiting for blood clot formation in the half of the sample while Biphasic Calcium Phosphate (BCP) scaffold will be applied in other half of the sample with two types of coronal sealing materials (Bioceramic root repair material BC RRM & Mineral Trioxide Aggregate MTA) will be used with both scaffolds.
Participants will be informed of the need to have a dental check-up periodically, and if any adverse event is observed, they will proceed to Plan B (conventional Root Canal Treatment RCT), with periodic reminder by short message service.
The application of all topical agents will be done by an experienced investigator and the intervention will be delivered at the clinics of the College of Dentistry.
Neutral investigators (Practitioners who don't know the applied materials) will monitor the cases clinically and radiologically during additional 5 successive visits prolong on periods 3-6-9-12-15 months; (each visit will last about 15 minutes, after two primary visits of about one hour each) and the results will be compared, where the absence of symptoms and clinical signs and the periapical healing will be considered as the main criterion of success.
Intervention code [1] 318455 0
Treatment: Other
Comparator / control treatment
Blood clot scaffold and MTA, arm 4
could be selected as a comparator
Control group
Active

Outcomes
Primary outcome [1] 324927 0
composite primary outcome regarding to
1: absence of symptoms (pain; according to visual analogue scale VAS)
2: absence of clinical signs (swelling, fistula, pockets according to community periodontal index of treatment needs CPITN and movement degree according to Miller scale)
3: periapical healing (according to periapical index PAI)
All that will be considered the main criterion of success, the observation will be done by blinded investigators using scoring criteria according to clinical and radiological scale suggested previously.
Timepoint [1] 324927 0
(T0) Baseline immediately after treatment
Revaluation in 5 intervals:
(T1) : 3 months after applying treatment.
(T2): 6 months after applying treatment.
(T3): 9 months after applying treatment.
(T4): 12 months after applying treatment.
(T5): 15 months after applying treatment.
Secondary outcome [1] 386237 0
Based on the method of assessment for each component
Patient discomfort, tooth movement, large swelling... etc are considered as an adverse events in accordance to success and failure criteria of American Association of Endodontics AAE.
Timepoint [1] 386237 0
It will be evaluated right after the patient complainment; adverse events will be monitored and after 6 months till 12 months then the plan b will start.

Eligibility
Key inclusion criteria
-Non-vital pulp teeth caused by trauma, penetrating caries, or improper medical interventions.
-Single-canal teeth (single-canal anterior teeth and single-canal premolars).
-Periapical lesion is classified from 3 to 5 according to a scale (Orstavik, 1996).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Lesions exceeding the size of a 5 mm.
-Significant expansion of the ligamentous distance with intense movement.
-The possibility of radical cysts.
-Anomalies.
-Curvature.
-Absorption.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation for patients will be done using a randomisation table created by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using software of G-Power 3.1.9.2 .
Statistical analyses will be performed using SPSS ( statistical software ) for Windows 10 platform (version 22.0, SPSS Inc.,Chicago,IL,USA).
One-way Anova test will be performed.
the Wilcoxon signed-rank test will be performed.
The significance level was set at 0.05 .

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
Actual
1/09/2018
Date of last participant enrolment
Anticipated
Actual
1/12/2018
Date of last data collection
Anticipated
Actual
1/04/2020
Sample size
Target
60
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 22897 0
Syrian Arab Republic
State/province [1] 22897 0
Damascus

Funding & Sponsors
Funding source category [1] 306583 0
University
Name [1] 306583 0
Damascus University
Country [1] 306583 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 307108 0
None
Name [1] 307108 0
None
Address [1] 307108 0
None
Country [1] 307108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306766 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 306766 0
Ethics committee country [1] 306766 0
Syrian Arab Republic
Date submitted for ethics approval [1] 306766 0
28/06/2018
Approval date [1] 306766 0
24/07/2018
Ethics approval number [1] 306766 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104950 0
Dr Mohammad Yaman Seirawan
Address 104950 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 104950 0
Syrian Arab Republic
Phone 104950 0
+963999520717
Fax 104950 0
Email 104950 0
yamansr@hotmail.com
Contact person for public queries
Name 104951 0
Mohammad Yaman Seirawan
Address 104951 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 104951 0
Syrian Arab Republic
Phone 104951 0
+963999520717
Fax 104951 0
Email 104951 0
yamansr@hotmail.com
Contact person for scientific queries
Name 104952 0
Mohammad Yaman Seirawan
Address 104952 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 104952 0
Syrian Arab Republic
Phone 104952 0
+963999520717
Fax 104952 0
Email 104952 0
yamansr@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8976Study protocol  yanansr@hotmail.com
8977Informed consent form  yanansr@hotmail.com
8978Ethical approval  yanansr@hotmail.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.