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Trial registered on ANZCTR


Registration number
ACTRN12624000900516
Ethics application status
Approved
Date submitted
29/03/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
comparison of Composites fillings in Posterior Teeth
Scientific title
Clinical Evaluation of Bulk-fill Flowable Composite vs Traditional nano-hybrid Composites in Posterior Teeth; comparing the retention rates ,marginal integrity and post operative sensitivity.
Secondary ID [1] 311855 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 333391 0
Condition category
Condition code
Oral and Gastrointestinal 330080 330080 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
bulk-fill flowable composite and conventional nano-hybrid composites for the restoration of posterior teeth for occlusal and proximal lesions was evaluated.
the bulk-fill flowable composite will be delivered via a pre-filled 2G syringe according to manufacturer instructions.. the restoration process will take 1 hr under controlled conditions by a specialist dentist.bulk filled flowable composite is composed of light cured Nanahybrid resin with ivocerin .the intervention differs from conventional nanohybrid composite is that the former requires only one curing increment and latter require increments. the intervention will be completed in one visit
Intervention code [1] 328314 0
Treatment: Devices
Comparator / control treatment
traditional nano hybrid composite will be delivered via a pre-filled 2G syringe will be delivered according to manufacturer instruction under controlled conditions by specialist dentist.the procedure will take 1 hr. the conventional nanohybrid composite is composed of resin matrix with filler upto 65 % of the volume , it is cured in 2 mm thickness in increments for all the occulusal and proximal caries.. the intervention will be completed in one visit.
Control group
Active

Outcomes
Primary outcome [1] 337835 0
retention of composite filling
Timepoint [1] 337835 0
3 month after filling are placed
Secondary outcome [1] 433427 0
marginal integrity
Timepoint [1] 433427 0
6 months after filling
Secondary outcome [2] 437802 0
post-operative sensitivity
Timepoint [2] 437802 0
baseline and 3 months

Eligibility
Key inclusion criteria
Patients of both genders of any age. All Posterior teeth with occlusal, proximal carious lesions, structural damage. Patients with good oral hygiene and patients able to provide informed consent and commit to the follow-up visits for 12 months.
Minimum age
6 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Teeth requiring indirect restorations, severe Periodontal disease or tooth mobility, Para-functional habits, Clinical and Radiographic evidence of Apical periodontitis or Irreversible Pulpitis

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer genrated sequence
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2024
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
10/04/2025
Actual
Sample size
Target
90
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26224 0
Pakistan
State/province [1] 26224 0
punjab

Funding & Sponsors
Funding source category [1] 316200 0
Self funded/Unfunded
Name [1] 316200 0
nil
Country [1] 316200 0
Primary sponsor type
Hospital
Name
Bakhtawar Amin Medical and Dental College
Address
Country
Pakistan
Secondary sponsor category [1] 319269 0
None
Name [1] 319269 0
Address [1] 319269 0
Country [1] 319269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315016 0
bakhtawar amin dental ethical review board
Ethics committee address [1] 315016 0
northern bypass matti tal road Multan. 60000
Ethics committee country [1] 315016 0
Pakistan
Date submitted for ethics approval [1] 315016 0
22/06/2022
Approval date [1] 315016 0
13/10/2022
Ethics approval number [1] 315016 0

Summary
Brief summary
this study is to evaluate and compare the clinical performance of tooth colored composites for the restoration of posterior teeth. the bulk fill flowable composites are viable alternative to traditional nanohybrid composites.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133434 0
Dr hafiz adil
Address 133434 0
adil bakhtawar amin medical and dental college, Northern bypass multan 60000
Country 133434 0
Pakistan
Phone 133434 0
+9203115066698
Fax 133434 0
Email 133434 0
[email protected]
Contact person for public queries
Name 133435 0
jazib pervez
Address 133435 0
jazib pervez bakhtawar amin medical and dental college, Northern bypass multan 60000
Country 133435 0
Pakistan
Phone 133435 0
+9203334627464
Fax 133435 0
Email 133435 0
[email protected]
Contact person for scientific queries
Name 133436 0
jazib pervez
Address 133436 0
adil bakhtawar amin medical and dental college, Northern bypass multan 60000
Country 133436 0
Pakistan
Phone 133436 0
+9203334627464
Fax 133436 0
Email 133436 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.