Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000248460
Ethics application status
Approved
Date submitted
14/09/2024
Date registered
4/04/2025
Date last updated
4/04/2025
Date data sharing statement initially provided
4/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Mean Pain Between Pulpotomy and Pulpectomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Scientific title
Comparison of Mean Pain Between Pulpotomy and Pulpectomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Secondary ID [1] 312972 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Irreversible Pulpitis 335147 0
oral health 335148 0
Diseases of the mouth, teeth 335149 0
Condition category
Condition code
Oral and Gastrointestinal 331644 331644 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
1. Physical or Informational Materials
Participants will be provided with a Visual Analogue Scale (VAS) to record their pain levels post-procedure.

Standardized questionnaires will be given daily for seven days to assess post-operative discomfort.

Radiographic examinations and clinical documentation will be recorded for diagnosis and treatment planning.

Rubber dam, local anesthetic (Septodent- 2% Lidocaine, epinephrine 1:100000), hand K files (Mani- K Files), sodium hypochlorite (Tehnodent), EDTA (PD -EDTA 17% Gel), and absorbent paper points (Meta BioMed) will be used during intervention procedures.

2. Procedures, Activities, and Processes
Pulpotomy: The complete removal of coronal pulp, followed by the placement of a biocompatible material.

Pulpectomy: Complete removal of pulp tissue, working length determination, chemomechanical preparation using the Step Back technique, and root canal filling with intracanal medications.

Both procedures will involve local anesthesia, rubber dam isolation, and irrigation with sodium hypochlorite.

3. Intervention Providers and Their Expertise
The intervention will be carried out by qualified dental practitioners from the Department of Operative Dentistry at Saidu College of Dentistry, Swat.

The practitioners will have relevant experience in endodontic procedures, ensuring standardized and professional care.

4. Mode of Delivery
The interventions will be provided in a face-to-face clinical setting.

Each intervention will be conducted individually for each patient.

5. Number of Sessions, Schedule, and Duration
Each participant will undergo a single treatment session (either pulpotomy or pulpectomy).

Postoperative pain assessment will be conducted at 12 hours, 24 hours, and daily for seven days using the VAS scale.

6. Location of Intervention
The study will be conducted at the Department of Operative Dentistry, Saidu College of Dentistry, Swat.

Personalization, Adaptation, and Adherence
The intervention is not personalized but follows a standardized protocol for both pulpotomy and pulpectomy groups.

Adherence to the intervention will be assessed through follow-up calls at 24 hours post-procedure and daily pain assessments using the questionnaire.

To maintain fidelity, trained practitioners will perform the interventions, ensuring consistent procedural steps.
Intervention code [1] 329507 0
Treatment: Other
Comparator / control treatment
Comparator/Control Arm Description
The study is a controlled trial comparing pulpotomy and pulpectomy in managing deep carious lesions in primary molars.

Comparator/Control Treatment
The pulpotomy procedure serves as the active control for comparison against pulpectomy.

Details of the Comparator (Pulpotomy)
Materials Used: Local anesthesia (Septodent- 2% Lidocaine, epinephrine 1:100000), rubber dam, sodium hypochlorite (Tehnodent), and calcium hydroxide/ MTA as a pulp capping material.

Procedure: Coronal pulp removal, hemostasis, medicament application, and final restoration.

Mode of Delivery: Face-to-face, individually performed in a clinical setting.

Dose and Duration: Single intervention session per patient, with post-treatment follow-ups at 12 hours, 24 hours, and daily for 7 days.

Location: Department of Operative Dentistry, Saidu College of Dentistry, Swat
Control group
Active

Outcomes
Primary outcome [1] 339376 0
Mean pain score
Timepoint [1] 339376 0
24 hours post-procedure
Secondary outcome [1] 439708 0
Pain severity
Timepoint [1] 439708 0
24 hours post procedure

Eligibility
Key inclusion criteria
- Patients aged 12-65 years.
- Diagnosed with symptomatic irreversible pulpitis based on clinical and radiographic findings
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Systemic diseases contraindicating dental procedures (e.g., MI, uncontrolled diabetes).
- Pregnancy
patients with apical periodontitis(pulpotomy can not be performed)

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 phone/fax/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 (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
584
Accrual to date
Final
Recruitment outside Australia
Country [1] 26560 0
Pakistan
State/province [1] 26560 0
khyber pakhtunkhwa

Funding & Sponsors
Funding source category [1] 317404 0
Self funded/Unfunded
Name [1] 317404 0
Country [1] 317404 0
Primary sponsor type
Individual
Name
self, Dr Faiz Ur Rahman,saidu college of Dentistry ,Swat
Address
Country
Pakistan
Secondary sponsor category [1] 319694 0
None
Name [1] 319694 0
Address [1] 319694 0
Country [1] 319694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316130 0
saidu medical college
Ethics committee address [1] 316130 0
Ethics committee country [1] 316130 0
Pakistan
Date submitted for ethics approval [1] 316130 0
20/02/2024
Approval date [1] 316130 0
27/02/2024
Ethics approval number [1] 316130 0

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

Contacts
Principal investigator
Name 136890 0
Dr Faiz Rahman
Address 136890 0
operative dentistry ward saidu college of dentistry, swat, khyber pakhtunkhwa, postal code 19200
Country 136890 0
Pakistan
Phone 136890 0
+923451505838
Fax 136890 0
Email 136890 0
[email protected]
Contact person for public queries
Name 136891 0
Faiz Rahman
Address 136891 0
operative dentistry ward saidu college of dentistry, swat, khyber pakhtunkhwa, postal code 19200
Country 136891 0
Pakistan
Phone 136891 0
+923451505838
Fax 136891 0
Email 136891 0
[email protected]
Contact person for scientific queries
Name 136892 0
Faiz Rahman
Address 136892 0
operative dentistry ward saidu college of dentistry, swat, khyber pakhtunkhwa, postal code 19200
Country 136892 0
Pakistan
Phone 136892 0
+923451505838
Fax 136892 0
Email 136892 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.