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Trial registered on ANZCTR


Registration number
ACTRN12623000785606
Ethics application status
Approved
Date submitted
27/02/2023
Date registered
19/07/2023
Date last updated
19/07/2023
Date data sharing statement initially provided
19/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of zinc oxide eugenol and metapex as root canal filling material following pulpectomy in primary molars
Scientific title
Comparison of zinc oxide eugenol and metapex as root canal filling material following pulpectomy in primary molars of children aged 4-9 years old
Secondary ID [1] 309040 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Pandranki J, Vanga NR, Chandrabhatla SK. Zinc oxide eugenol and Endoflas pulpectomy in primary molars: 24-month clinical and radiographic evaluation. J. Indian Soc. Pedod. Prev. Dent. 2018 Apr 1;36(2):173.

This study is parent study of my publication and i have deduced my sample size from this study

Health condition
Health condition(s) or problem(s) studied:
Symptomatic irreversible pulpitis 329092 0
Pulpal necrosis 329093 0
Condition category
Condition code
Oral and Gastrointestinal 326068 326068 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
Use of metapex or zinc oxide eugenol following pulpectomy in primary molars
INN Metapex (calcium hydroxide paste containing iodoform and barium sulphate as a radioopacifier,
INN ZnOE: powder containing zinc oxide and zinc acetate mixed with liquid of eugenol and rosin.
No specific dose, amount dispensed should be enough to reach the apical third of roots
Procedure: pulpectomy followed by root filling
Dental surgeon will administer metapex or ZnOE
Duration: 30 mins for whole procedure with once only administration
Intervention code [1] 325499 0
Treatment: Drugs
Comparator / control treatment
Control group consists of 30 participants in whom zinc oxide eugenol will be used
Procedure : pulpectomy followed by root filling
Dental surgeon will administer ZnOE
Duration: 30 mins for whole procedure with once only administration
Control group
Active

Outcomes
Primary outcome [1] 333953 0
Evaluation of clinical and radiographic symptoms following use of zinc oxide eugenol or metapex in primary molars
1. Pain - will be assessed through VAS scale
Timepoint [1] 333953 0
At 6 months after treatment
Primary outcome [2] 335303 0
Tenderness - through palpation
Timepoint [2] 335303 0
At 6 months after treatment
Primary outcome [3] 335304 0
Draining fistula -on intraoral examintion
Timepoint [3] 335304 0
At 6 months after treatment
Secondary outcome [1] 418825 0
Evaluation of clinical and radiographic symptoms following use of zinc oxide eugenol or metapex in primary molars
1. Change in size of periapical radiolucency
Timepoint [1] 418825 0
Immediately post operative
At 3 months
At 6 months
Secondary outcome [2] 423834 0
2. Presence or absence of external or internal resorption
Timepoint [2] 423834 0
Immediately post operative
At 3 months
At 6 months
Secondary outcome [3] 423835 0
Presence or absence of any pathology for example cyst
Timepoint [3] 423835 0
Immediately post operative
At 3 months
At 6 months

Eligibility
Key inclusion criteria
1. Age groups:4-9 years
2. History of spontaneous pain due to caries
3. Teeth with clinical signs of either chronic irreversible pulpitis or pulp necrosis such as gingival swelling or sinus tract/purulence or mild pathological mobility
4. Continuous bleeding after amputation of coronal pulp
5. Physiological or pathological external root resorption limited to apical third and with at least two-thirds root intact.
Minimum age
4 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nonrestorable teeth.
2. Teeth exhibiting grade 2 or grade 3 mobility.
3. Teeth demonstrating extensive external/internal resorption.
4. Teeth with reversible pulpitis
5. Children having some congenital abnormalities.

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)
Simple randomisation using a randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Non probability consecutive sampling

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25280 0
Pakistan
State/province [1] 25280 0
Punjab

Funding & Sponsors
Funding source category [1] 313244 0
Hospital
Name [1] 313244 0
Armed forces Institute of Dentistry
Country [1] 313244 0
Pakistan
Primary sponsor type
Individual
Name
Sana Ashfaq
Address
Operative department, Armed Forces Institute of Dentistry, Tamiz-ud-din Road Rawalpindi, Pakistan
Country
Pakistan
Secondary sponsor category [1] 314972 0
Hospital
Name [1] 314972 0
Armed forces institute of dentistry
Address [1] 314972 0
AFID, CMH, tamiz ud din road, Rawalpindi
Country [1] 314972 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312476 0
AFID ethical committee
Ethics committee address [1] 312476 0
Ethics committee country [1] 312476 0
Pakistan
Date submitted for ethics approval [1] 312476 0
02/01/2023
Approval date [1] 312476 0
01/02/2023
Ethics approval number [1] 312476 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124798 0
Dr Sana Ashfaq
Address 124798 0
Operative department, Armed Forces Institute of Dentistry, tamiz-ud-din road, Rawalpind, Pakistan
Country 124798 0
Pakistan
Phone 124798 0
+923225153215
Fax 124798 0
Email 124798 0
sanaashfaq7@gmail.com
Contact person for public queries
Name 124799 0
Sana Ashfaq
Address 124799 0
Operative department, Armed Forces Institute of Dentistry, tamiz-ud-din road, Rawalpind, Pakistan
Country 124799 0
Pakistan
Phone 124799 0
+923225153215
Fax 124799 0
Email 124799 0
sanaashfaq7@gmail.com
Contact person for scientific queries
Name 124800 0
Sana Ashfaq
Address 124800 0
House 969, street 92, I-8/4, Islamabad
Country 124800 0
Pakistan
Phone 124800 0
+923225153215
Fax 124800 0
Email 124800 0
sanaashfaq7@gmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18446Informed consent form  sanaashfaq7@gmail.com
18447Ethical approval    385435-(Uploaded-27-02-2023-03-29-01)-Study-related document.pdf



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.