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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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

(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]

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]

Secondary outcome [1]

healing of soft tissue around the treated molars as assessed with periodontal evaluation using the periodontal indexes

Timepoint [1]

Secondary outcome [2]

Safety of the bony region around the tooth.
Evaluation by taking periapical radiographs.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Syrian Arab Republic

State/province [1]

Damascus

Funding & Sponsors

Funding source category [1]

University

Name [1]

Damascus University

Address [1]

Dental College,Damascus University, Al Mazzeh street, Damascus

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical and Scientific Committee of dental research.

Ethics committee address [1]

Dental College,Damascus University,Al-Mazzeh street,Damascus,Syria,.Damas 13203

Ethics committee country [1]

Syrian Arab Republic

Date submitted for ethics approval [1]

01/09/2020

Approval date [1]

11/09/2020

Ethics approval number [1]

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

Dr DR Ibrahim Al nassar

Address

Dental College,Damascus University,Al-Mazzeh street,Damascus, Damas 13203

Country

Syrian Arab Republic

Phone

+963937771430

Fax

[email protected]

Contact person for public queries

Name

DR Ibrahim Al nassar

Address

Dental College,Damascus University,Al-Mazzeh street,Damascus, Damas13203

Country

Syrian Arab Republic

Phone

+963937771430

Fax

[email protected]

Contact person for scientific queries

Name

DR Ibrahim Al nassar

Address

Dental College,Damascus University,Al-Mazzeh street,Damascus,Damas 13203

Country

Syrian Arab Republic

Phone

+963937771430

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
10996	Study protocol	[email protected]
10997	Informed consent form	[email protected]
10998	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically