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Trial registered on ANZCTR


Registration number
ACTRN12621001631897
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study to evaluate effectiveness of TWO materials in vital pulpotomy in immature permanent and primary teeth
Scientific title
Comparative study to evaluate effectiveness of Mineral trioxide aggregate (MTA) and Bioceramic (putty) materials in preserving function of immature permanent and primary teeth after vital pulpotomy in children aged 6 to 9 years
Secondary ID [1] 303639 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulpotomy in immature permanent and primary molars 321024 0
Condition category
Condition code
Oral and Gastrointestinal 318827 318827 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
pulpotomy for primary molars with irreversible pulpitis, pulpotomy for immature permanent molars with irreversible and reversible pulpitis using Mineral trioxide aggregate( MTA ) and Bioceramic (putty) materials followed by stainless steel crowns.
the primary molars was dividing in two groups,each group contains 20 primary molars according to the material using in pulpotomy.
Immature permanent molars with irreversible pulpitis dividing into two groups according to material using in pulpotomy,each group contains 12 patient.
Immature permanent molars with reversible pulpitis dividing into two groups according to material using in pulpotomy,each group contains 12 patient.
After Proper local anesthesia was achieved and isolate the molar using rubber dam, the caries was removed, the pulp chamber was opened,the coronal pulp tissue were removed using sharp excavator,the Hemostasis was achieved using Cotton balls moistened with distilled water for five minutes in case of reversible pulpitis , but in cases of irreversible pulpitis Hemostasis was controlled by applying pressure using cotton balls moistened with sodium hypochloride at a concentration of 2.5% at intervals of two minutes until hemostasis is obtained, provided that the total time does not exceed 15 minutes,after that the selective material was applied followed by stainless steel crown.
The researcher himself will do the procedures, Intervention time is about an hour.
Place of work, Damascus University, Faculty of Dentistry, Department of Pediatric Dentistry.
Follow-up and patient evaluation will be organized through archived records specific to a specific time in the records of the Department of Pediatric Dentistry.
Intervention code [1] 319952 0
Rehabilitation
Intervention code [2] 319953 0
Treatment: Other
Intervention code [3] 319956 0
Prevention
Comparator / control treatment
Active Treatment using MTA material in each group is comparative with treatment using bioceramic, treatment using MTA is considered the control in each group
Control group
Active

Outcomes
Primary outcome [1] 326793 0
Clinical Success of Pulpotomy Treatment at all time points evaluated by the primary investigator and two other blinded calibrated examiners.
clinical success appears as painless functional tooth
Timepoint [1] 326793 0
(To)Baseline and re_evaluate in five times intervals stages:
(T1) 1 week after treatment.
(T2) 3 months after treatment.
(T3) 6 months after treatment,
(T4) 9 months after treatment.
(T5) 12 months after treatment.
Primary endpoint is T5
Primary outcome [2] 326794 0
Radiographic Success of Pulpotomy Treatment in all time points evaluated by the primary investigator and two other blinded calibrated examiners.
Radiographic Success appears as extent of root development or apex closure in periapical radiographs
Timepoint [2] 326794 0
(To)Baseline and re_evaluate in five times intervals stages:
(T1) 1 week after treatment.
(T2) 3 months after treatment.
(T3) 6 months after treatment,
(T4) 9 months after treatment.
(T5) 12 months after treatment
Primary endpoint is T5
Secondary outcome [1] 392698 0
healing of soft tissue around the treated molars as assessed with periodontal evaluation using the periodontal indexes
Timepoint [1] 392698 0
(To)Baseline and re_evaluate in five times intervals stages:
(T1) 1 week after treatment.
(T2) 3 months after treatment.
(T3) 6 months after treatment,
(T4) 9 months after treatment.
(T5) 12 months after treatment
Secondary outcome [2] 392699 0
Safety of the bony region around the tooth.
Evaluation by taking periapical radiographs.
Timepoint [2] 392699 0
(To)Baseline and re_evaluate in five times intervals stages:
(T1) 1 week after treatment.
(T2) 3 months after treatment.
(T3) 6 months after treatment,
(T4) 9 months after treatment.
(T5) 12 months after treatment

Eligibility
Key inclusion criteria
1_primary molas with irreversible pulpitis.
2_immuture permanent molars with irreversible and reversible pulptis.
3_cooperative patient.
4-Absence of symptoms and signs that indicate necrotic pulp( swelling, movement, fistula).
5_Parental approval.
6_Having two-thirds the length of the root in primary molars.
7_ absence of systemic diseases that affect healing.
8_Absence of radiographic symptoms and signs(internal or external resorption, calcification,periapical lesion).
9_Good oral hygiene.
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1_children with known systemic disease,mental disability or abnormal para-functional habits.
2_patient who had the behavioral rating ( definitely negative ) according to the Frankle behavior classification scale.

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 randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization for children will be done using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simple size was calcuted using G_power 3.1 software. The significance level was set at 0.05 and the power of the study was set to be 0.80.
The SPSS version 20 program will be used for conducting statistical analyzes, where we will conduct:
• Study the distribution of data using the kolmogrov-smirnov test.
• Conducting descriptive tests.
• Conducting a chi-square test to study the significance of differences in the frequency of success and failure clinically and radiologically, between the research sample groups according to the material used and the period of time studied.
• Mcnemar's test to study the significance of differences between treatment outcome clinically and radiotherapy outcome.
The level of significance will be set at 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
1/03/2021
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
88
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 23530 0
Syrian Arab Republic
State/province [1] 23530 0
Damascus

Funding & Sponsors
Funding source category [1] 308059 0
University
Name [1] 308059 0
Damascus University
Country [1] 308059 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College,Damascus University, Al Mazzeh street, Damascus
Country
Syrian Arab Republic
Secondary sponsor category [1] 308788 0
None
Name [1] 308788 0
None
Address [1] 308788 0
None
Country [1] 308788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308051 0
Ethical and Scientific Committee of dental research.
Ethics committee address [1] 308051 0
Dental College,Damascus University,Al-Mazzeh street,Damascus,Syria,.Damas 13203
Ethics committee country [1] 308051 0
Syrian Arab Republic
Date submitted for ethics approval [1] 308051 0
01/09/2020
Approval date [1] 308051 0
11/09/2020
Ethics approval number [1] 308051 0

Summary
Brief summary
The aim of this study is to evaluate and compare the clinical and radiographic of MTA and biocerami (putty) in pulpotomy for primary and immature permanent molars over one week,three ,six,nine,twelve months regarding recovery failure,vitality of the pulp,root development,bone integrity,gingival response.
Randomized controlled clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109350 0
Dr DR Ibrahim Al nassar
Address 109350 0
Dental College,Damascus University,Al-Mazzeh street,Damascus, Damas 13203
Country 109350 0
Syrian Arab Republic
Phone 109350 0
+963937771430
Fax 109350 0
Email 109350 0
[email protected]
Contact person for public queries
Name 109351 0
DR Ibrahim Al nassar
Address 109351 0
Dental College,Damascus University,Al-Mazzeh street,Damascus, Damas13203
Country 109351 0
Syrian Arab Republic
Phone 109351 0
+963937771430
Fax 109351 0
Email 109351 0
[email protected]
Contact person for scientific queries
Name 109352 0
DR Ibrahim Al nassar
Address 109352 0
Dental College,Damascus University,Al-Mazzeh street,Damascus,Damas 13203
Country 109352 0
Syrian Arab Republic
Phone 109352 0
+963937771430
Fax 109352 0
Email 109352 0
[email protected]

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
10996Study protocol  [email protected]
10997Informed consent form  [email protected]
10998Ethical approval  [email protected]



Results publications and other study-related documents

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