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Trial registered on ANZCTR


Registration number
ACTRN12619001280190
Ethics application status
Approved
Date submitted
17/07/2019
Date registered
17/09/2019
Date last updated
17/09/2019
Date data sharing statement initially provided
17/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical agents for vital pulpotomy in primary teeth
Scientific title
Evaluation of the Effectiveness of Chitosan as dressing material in Primary Molars pulpotomy for Children Aged 5 – 8 Years
Secondary ID [1] 298731 0
None
Universal Trial Number (UTN)
U1111-1236-9649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 313659 0
Condition category
Condition code
Oral and Gastrointestinal 312075 312075 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
Second primary carious molars in children aged 5 - 8 years will be randomly divided into 2 groups:
Arm1: (0.2 g Chitosan)
Arm2: (0.2 g Mineral trioxide aggregate (MTA))
Each patient will receive vital pulpotomy in both second primary molars; in a split mouth design.
Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed.
Regional anesthesia will be performed, all cavity lesions will be removed, and an access cavity will be prepared under the isolation of rubber dam. A low-speed sterile round bur will be used for removing coronal pulp.
bleeding will be stopped using Sterile cotton pellets moistened with sterile saline. Then, pulp stumps will be covered with either chitosan films, or MTA.
All pulpotomized teeth will be restored with stainless steel crowns.
Interventions will be done by a pediatric dentistry resident and will take place in faculty of dentistry at Damascus university.
Clinical and radiographic evaluation will be performed after 3, 6 and 9 Months
Intervention code [1] 314996 0
Treatment: Drugs
Comparator / control treatment
Mineral trioxide aggregate (MTA)
Control group
Active

Outcomes
Primary outcome [1] 320708 0
Efficacy of Chitosan as a pulpotomy medicament in primary teeth will be assessed clinically and radiographically
Timepoint [1] 320708 0
(To) Re-evaluate clinically and radiographically in three time interval stages:
(T1): 3 months after treatment
(T2): 6 months after treatment
(T3): 9 months after treatment
Secondary outcome [1] 372583 0
Nil
Timepoint [1] 372583 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria of participants:
1. Healthy and Cooperative patients approving the trial.
Inclusion Criteria of teeth:
1. Tooth is restorable.
2. Hemostasis achieved within 5 minutes during clinical procedure.
3. Presence of two-thirds of the root length radiographically.
Minimum age
5 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical Signs and symptoms that indicate an infected pulp: abnormal tooth mobility, sensitivity to percussion, and gingival abscess or fistula associated with a tooth.
2. Radiographic evidence of pulp degeneration: internal or external root resorption, and interradicular or periapical bone destruction.

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 using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Split mouth
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculate 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.
Based on a Chi – Square test, it was estimate that 50 patients were required to demonstrate an effect size (0.4).
Sample size will be raised to 60 patients to avoid the negative effect of the possible drop rate.
Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).

The chi-square and McNemar test will be performed. A P value <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2019
Actual
Date of last participant enrolment
Anticipated
11/02/2020
Actual
Date of last data collection
Anticipated
11/11/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21685 0
Syrian Arab Republic
State/province [1] 21685 0
Damascus

Funding & Sponsors
Funding source category [1] 303284 0
University
Name [1] 303284 0
Damascus University
Country [1] 303284 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria, PO Box 30621
Country
Syrian Arab Republic
Secondary sponsor category [1] 303304 0
None
Name [1] 303304 0
None
Address [1] 303304 0
None
Country [1] 303304 0
Other collaborator category [1] 280851 0
University
Name [1] 280851 0
Damascus University
Address [1] 280851 0
Faculty of Science, Damascus University, Baramkah (Fawzi Al-Laham St), Damascus, Syria, PO Box 30621
Country [1] 280851 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303821 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 303821 0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 303821 0
Syrian Arab Republic
Date submitted for ethics approval [1] 303821 0
12/03/2019
Approval date [1] 303821 0
19/05/2019
Ethics approval number [1] 303821 0

Summary
Brief summary
The aim of this study is to assess the clinical and radiographic effectiveness of Chitosan films compared with mineral trioxide aggregate (MTA) as dressing material in Primary Molars pulpotomy.

Randomized controlled clinical trial
The null hypothesis tested is that there is no statistically significant difference in clinical and radiographic success rates between Chitosan films and MTA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94926 0
Dr Bushra Shamma
Address 94926 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 94926 0
Syrian Arab Republic
Phone 94926 0
+963931463739
Fax 94926 0
Email 94926 0
[email protected]
Contact person for public queries
Name 94927 0
Bushra Shamma
Address 94927 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 94927 0
Syrian Arab Republic
Phone 94927 0
+963931463739
Fax 94927 0
Email 94927 0
[email protected]
Contact person for scientific queries
Name 94928 0
Bushra Shamma
Address 94928 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 94928 0
Syrian Arab Republic
Phone 94928 0
+963931463739
Fax 94928 0
Email 94928 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?

No Supporting Document Provided



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.