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Trial registered on ANZCTR


Registration number
ACTRN12622001396718
Ethics application status
Approved
Date submitted
8/09/2022
Date registered
1/11/2022
Date last updated
21/12/2022
Date data sharing statement initially provided
1/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and Radiographic Comparison of Biodentine and Calcium Hydroxide Cement as Indirect Pulp Capping Agents
Scientific title
Comparison of pulpal response to Biodentine and Calcium hydroxide cement as an indirect pulp capping agent in adults with deep carious lesions
Secondary ID [1] 307944 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reversible Pulpitis 327599 0
Condition category
Condition code
Oral and Gastrointestinal 324686 324686 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
The study will be conducted in compliance with CONSORT guidelines. 68 teeth (34 in each group calculated by WHO sample calculator) teeth in systemically healthy adult patients with carious permanent tooth identified by digital periapical radiographs using ICDAS radiographic scoring system (RC5) and absence of signs and symptoms of irreversible pulpitis, having positive pulp response to electrical and thermal stimulations will be included. On the contrary, teeth with mobility, fracture or internal resorption, sensitivity to percussion, third molars, pregnant women (considering requirements for radiographs) and teeth with pulp exposure during caries excavation will be excluded.
After a brief explanation of the procedure, efficacy and safety of the materials, and possibilities of receiving either treatment option that is Biodentine (80.1% tricalcium silicate) or Dycal (calcium hydroxide), informed written consent will be obtained. Indirect pulp capping will be performed by a trained specialist . It involves removing soft, infected dentin with round diamond cutting burs in a high-speed handpiece followed by the removal of deeper caries using slow-speed handpiece. After caries removal, each tooth will be restored either by Biodentine or dycal (<1ml is required, depends on the cavity size and shape). The duration of indirect pulp capping and placement of restoration was approximately completed in 45minutes. Teeth restored with biodentine will receive definitive composite restoration 2 weeks after the treatment by 2mm reduction of biodentine, while teeth treated with dycal will receive GIC base and definitive composite filling in the same session. Composite filling will be performed in increments of 2mm that will be UV light cured for 20 seconds
Post-operative follow-ups for each group, will be done at two, six and twelve weeks. Each follow up session will take around 30min. At two and six weeks, a clinical assessment will be performed, while radiographic assessment to evaluate widening of periodontal ligament space or presence of periapical radiolucency will be done at 12 weeks.
Intervention code [1] 324405 0
Treatment: Drugs
Comparator / control treatment
Active Control (dycal: calcim hydroxide)
Control group
Active

Outcomes
Primary outcome [1] 332508 0
pain on percussion was recorded as yes or no
Timepoint [1] 332508 0
2 and 6 week (primary timepoint) after treatment
Primary outcome [2] 332714 0
thermal response was recorded by applying an ethyl chloride spray on the cotton bud and placing it on the buccal surface of the tooth for 5 seconds. The intensity and duration of pain after application was recorded
Timepoint [2] 332714 0
2 and 6 week (primary timepoint) after treatment
Secondary outcome [1] 413773 0
radiographic sign of pulp necrosis leading to inflammation of bone around the apex of tooth (peri-apical radiolucency) was recorded using PA intraoral radiograph
Timepoint [1] 413773 0
12 week after treatment

Eligibility
Key inclusion criteria
a. Patients in which deep carious lesion penetrating three-quarters into the dentin as identified with bitewing radiographs using ICDAS Radiographic scoring system (RC 5)
b. Any signs and symptoms of reversible pulpitis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Mobile teeth.
b. Tenderness to percussion.
c. Teeth with fracture and internal resorption.
d. Third molars.
e. Pregnant women, in view of requirements for radiographs.
f. Pulp exposure during removal of caries

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2022
Date of last participant enrolment
Anticipated
11/11/2022
Actual
9/11/2022
Date of last data collection
Anticipated
3/02/2023
Actual
Sample size
Target
68
Accrual to date
Final
83
Recruitment outside Australia
Country [1] 25003 0
Pakistan
State/province [1] 25003 0
Islamabad

Funding & Sponsors
Funding source category [1] 312212 0
Hospital
Name [1] 312212 0
Islamabad Dental hospital
Country [1] 312212 0
Pakistan
Primary sponsor type
University
Name
Islamabad Medical and Dental College
Address
Operative department, Islamabad Dental Hospital, Wadi-ul-Ilm,Main Murree Rd, Bhara Kahu, Islamabad
Country
Pakistan
Secondary sponsor category [1] 313739 0
None
Name [1] 313739 0
Address [1] 313739 0
Country [1] 313739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311593 0
Institutional Review Board, Islamabad Medical and Dental College (dental Section)
Ethics committee address [1] 311593 0
Islamabad Medical & Dental College (Dental Section), Wadi-ul-Ilm, Main Murree Rd, Bhara Kahu, Islamabad
Ethics committee country [1] 311593 0
Pakistan
Date submitted for ethics approval [1] 311593 0
Approval date [1] 311593 0
03/06/2016
Ethics approval number [1] 311593 0

Summary
Brief summary
This study assesses the efficacy of biodentine for the preservation of pulp vitality in deeply carious teeth. This study provides evidence that biodentine can be used as an alternative to calcium hydroxide cement (gold standard). The limitations of calcium hydroxide cement can be overcome with the use of biodentine due to its better mechanical strength, low solubility, and greater stimulation of the process of dentinogenesis. The results of this study will allow clinicians to take a realistic approach to the preservation of pulp vitality and reduce extensive invasive procedure such as extraction and root canal therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121646 0
Dr Saqib Arshad Khan
Address 121646 0
Department of Operative Dentistry, Islamabad Dental Hospital,, Wadi-ul-Ilm, Main Murree Rd, Bhara Kahu, Islamabad
Country 121646 0
Pakistan
Phone 121646 0
+923122612200
Fax 121646 0
Email 121646 0
[email protected]
Contact person for public queries
Name 121647 0
Saqib Arshad Khan
Address 121647 0
Department of Operative Dentistry, Islamabad Dental Hospital,, Wadi-ul-Ilm, Main Murree Rd, Bhara Kahu, Islamabad
Country 121647 0
Pakistan
Phone 121647 0
+923122612200
Fax 121647 0
Email 121647 0
[email protected]
Contact person for scientific queries
Name 121648 0
Saqib Arshad Khan
Address 121648 0
Department of Operative Dentistry, Islamabad Dental Hospital,, Wadi-ul-Ilm, Main Murree Rd, Bhara Kahu, Islamabad
Country 121648 0
Pakistan
Phone 121648 0
+923122612200
Fax 121648 0
Email 121648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
radiograph and filled record forms
When will data be available (start and end dates)?
Start date: immediate after registration- no end date
Available to whom?
case by case basis
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17102Ethical approval  [email protected]



Results publications and other study-related documents

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