Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001759886
Ethics application status
Approved
Date submitted
19/05/2021
Date registered
23/12/2021
Date last updated
23/12/2021
Date data sharing statement initially provided
23/12/2021
Date results information initially provided
23/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chemomechanical caries removal in primary teeth
Scientific title
Performance Evaluation of Enzyme Pepsin-based Gel in Chemomechanical caries removal (CMCR) for primary Anterior teeth
Secondary ID [1] 304223 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 321922 0
Condition category
Condition code
Oral and Gastrointestinal 319647 319647 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
Anterior primary teeth with class V caries in children aged 4-7 years, who screen in the Department of Pediatric Dentistry at Damascus university, will be involved in this split mouth design study
Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed.
The carious lesion will be covered with Enzyme Pepsin-based Gel and left undisturbed for 40 s. Then, it will be removed by scraping gently with a spoon excavator without application of any vertical pressure, under the isolation of rubber dam, this process will be repeated until the cavity appeare clean. caries detector dye will be used to confirm that the cavity is free of caries.
All teeth will be restored with Glass inomer cement.
The expected duration for the whole procedure is 20 minutes
A single practitioner will perform excavation of caries for all teeth so that caries removal and excavation will be identical.
Clinical and radiographic evaluation will be performed after 3 and 6 Months.
Intervention code [1] 320559 0
Treatment: Other
Comparator / control treatment
Carisolv solution will be used to remove caries in the control side.
The carious lesion will be covered with Carisolv solution and left undisturbed for 30 s. Then, it will be removed by scraping gently with a spoon excavator without application of any vertical pressure, under the isolation of rubber dam, this process will be repeated until the cavity appeare clean. caries detector dye will be used to confirm that the cavity is free of caries.
All teeth will be restored with Glass inomer cement.
The same practitioner will perform excavation of caries for all control teeth so that caries removal and excavation will be identical.
Clinical and radiographic evaluation will be performed after 3 and 6 Months.
Control group
Active

Outcomes
Primary outcome [1] 327518 0
Efficacy of Enzyme pepsin-based gel and Carisolv solution as a chemomechanical caries removal agent in primary teeth will be assessed clinically by another observer who did not know the treatment method, using Visual and tactile assessment by manual probing, and using a caries detector.
Timepoint [1] 327518 0
(T1): Immediately following caries removal
Secondary outcome [1] 395496 0
Evaluation of pain using Wong-Baker FACES pain rating scale
Timepoint [1] 395496 0
(T1): During caries removal
Secondary outcome [2] 395497 0
The need for anesthesia
In the presence of pain during the procedure, the Wong-Baker FACES pain rating scale would be used and when the score was greater than or equal to 3, local anesthesia would be administrated,
the need for the administration of anesthesia was based on the evaluation of the procedure, patient behavior, and the cause of the pain.
Timepoint [2] 395497 0
(T1): For the duration of the procedure,
Secondary outcome [3] 395498 0
Evaluation of caries relapse radiologically
Caries recurrence will be evaluated using periapical radiographs by another researcher without informing him of the method of removing caries, so he will evaluate the presence or absence of caries recurrence.
Timepoint [3] 395498 0
(T1): 3 months after treatment
(T2): 6 months after treatment
Secondary outcome [4] 401716 0
Evaluation of caries relapse clinically
The clinical examination will be conducted by the researcher in the absence of diagnostic cards in order to avoid knowing the type of treatment applied using a caries detector.
Timepoint [4] 401716 0
(T1): 3 months after treatment
(T2): 6 months after treatment
Secondary outcome [5] 401717 0
Evaluation of pulp vitality clinically
The clinical examination will be conducted by the researcher in the absence of diagnostic cards in order to avoid knowing the type of treatment applied through the absence of symptoms and clinical signs indicating pulp necrosis.
Timepoint [5] 401717 0
(T1): 3 months after treatment
(T2): 6 months after treatment
Secondary outcome [6] 401719 0
Evaluation of pulp vitality radiologically
Pulp vitality will be evaluated using periapical radiographs by another researcher without informing him of the method of removing caries through the absence of radiographic signs indicating pulp necrosis.
Timepoint [6] 401719 0
(T1): 3 months after treatment
(T2): 6 months after treatment
Secondary outcome [7] 401720 0
The number of materials application times
The number of both materials application times will be counted by the investigator from the start of caries removal till confirm the cavity is free of caries by caries detector dye.
Timepoint [7] 401720 0
During caries removal

Eligibility
Key inclusion criteria
Inclusion Criteria of participants:
1. Healthy and Cooperative patients approving the trial.
Inclusion Criteria of teeth:
1. Teeth with symmetric, open access ,buccal dentinal carious lesions in need of cosmetic restorations (the dental digital value by DIAGNOdent is 28-35)
2. vital teeth with no clinical or radiographic signs of pulpal involvement
3. have no defects in tooth formation or tooth development
Minimum age
4 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. unhealthy or non-Cooperative patients.
2. Clinical or radiographic Signs and symptoms that indicate an infected pulp
3. extensive depth of caries extend the pulpal third of dentine

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)
The side of the mouth that receives the intervention will be randomised by simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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 40patients were required to demonstrate an effect size (0.4).
Sample size will be raised to 46patients 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
Completed
Date of first participant enrolment
Anticipated
Actual
11/11/2019
Date of last participant enrolment
Anticipated
Actual
15/12/2020
Date of last data collection
Anticipated
Actual
16/06/2021
Sample size
Target
46
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 23708 0
Syrian Arab Republic
State/province [1] 23708 0
Damascus

Funding & Sponsors
Funding source category [1] 308602 0
University
Name [1] 308602 0
Damascus University
Country [1] 308602 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] 309462 0
None
Name [1] 309462 0
Address [1] 309462 0
Country [1] 309462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308533 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 308533 0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 308533 0
Syrian Arab Republic
Date submitted for ethics approval [1] 308533 0
14/05/2019
Approval date [1] 308533 0
24/06/2019
Ethics approval number [1] 308533 0

Summary
Brief summary
The aim of this study is to assess the clinical and radiographic effectiveness of Enzyme Pepsin-based Gel compared with carisolv solution as chemomechanical caries removal agents in Primary teeth.

Randomized controlled clinical trial
The null hypothesis tested is that there is no statistically significant difference in clinical and radiographic success rates between Enzyme Pepsin-based Gel and carisolv solution.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111042 0
Dr Douaa Aboalhuda
Address 111042 0
Dental College, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 111042 0
Syrian Arab Republic
Phone 111042 0
+963992951448
Fax 111042 0
Email 111042 0
[email protected]
Contact person for public queries
Name 111043 0
Dr Douaa Aboalhuda
Address 111043 0
Dental College, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 111043 0
Syrian Arab Republic
Phone 111043 0
+963992951448
Fax 111043 0
Email 111043 0
[email protected]
Contact person for scientific queries
Name 111044 0
Dr Douaa Aboalhuda
Address 111044 0
Dental College, Damascus University, Al-Mazzeh St. Damascus, PO Box 30621
Country 111044 0
Syrian Arab Republic
Phone 111044 0
+963992951448
Fax 111044 0
Email 111044 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.