Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000708459
Ethics application status
Approved
Date submitted
10/05/2025
Date registered
3/07/2025
Date last updated
3/07/2025
Date data sharing statement initially provided
3/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Mean post operative pain by comparing single and multiple visit Root canal treatment among patients with non-vital single rooted teeth.
Scientific title
Mean post operative pain by comparing single and multiple visit Root canal treatment among patients with non-vital single rooted teeth.
Secondary ID [1] 314405 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulpal disease 337413 0
Necrotic pulp 337414 0
Condition category
Condition code
Oral and Gastrointestinal 333793 333793 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
Participants will be randomly assigned to one of two groups.

Group A (Single-Visit Root Canal Treatment): Patients will receive complete root canal therapy, including cleaning, shaping, and obturation, in a single appointment of 2 hour duration. post operative Pain will be monitored by Visual analogue scale at 6hr , 24hr, 48hr and 7days interval.

Pain will be monitored by Visual analogue scale at 6hr , 24hr, 48hr and 7days interval.

Both groups will be treated under rubber dam isolation using standardized protocols and instrumentation techniques performed by qualified endodontist at Dental hospital (khyber college of dentistry).
Intervention code [1] 331010 0
Treatment: Other
Comparator / control treatment
Multiple-Visit Root Canal Treatment (Group B)

This group serves as the control or standard care group against which the experimental group (Single-Visit Root Canal Treatment) is compared. In this approach, the root canal procedure is divided into two or more visits, each visit will be around 45mins and with the placement of an intracanal medicament (like calcium hydroxide) between visits before final obturation. Final obturation will be done after 7 days. Post operative Pain will be monitored by Visual analogue scale at 6hr , 24hr, 48hr and 7days interval.
Control group
Active

Outcomes
Primary outcome [1] 341370 0
The primary outcome of my study is the mean post-operative pain experienced by patients after undergoing root canal treatment, comparing single-visit and multiple-visit procedures in patients with non-vital single-rooted teeth. This outcome will be measured using the Visual Analog Scale (VAS) at multiple time intervals (6 hours, 24 hours, 48 hours, and 7 days after treatment).
Timepoint [1] 341370 0
The primary timepoint for assessing post-operative pain in my study will be 24 hours after the root canal treatment. This is typically considered a key time for evaluating post-operative pain, as it often reflects the peak of discomfort following the procedure. However, pain will also be assessed at 6 hours, 48 hours, and 7 days to provide a more comprehensive understanding of the pain progression over time.
Secondary outcome [1] 447339 0
Post operative swelling
Timepoint [1] 447339 0
1 week after treatment. This allows time for swelling (if present) to manifest and gives an opportunity for a clinical follow-up to assess any ongoing issues.
Secondary outcome [2] 448797 0
Need for unscheduled visists
Timepoint [2] 448797 0
This can be assessed throughout the study duration (6 months), as patients may require unscheduled visits at any time due to pain, swelling, or complications.
Secondary outcome [3] 448798 0
Periapical healing
Timepoint [3] 448798 0
6 months after treatment. This allows enough time for periapical tissues to heal and shows any long-term effects of the root canal treatment.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Tooth should be non-vital, i.e. : Teeth responding negatively to cold test and electric pulp tester prior to anaesthesia.
2. Teeth having single canal with fully formed apex.
3. Teeth with severe pain (VAS 7-10) and radiographic evidence of periapical pathology.
4. Without complicating systemic disease. ASA 1 and 2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1.patient under 18years of age.
2. Teeth having acute apical abscesses .
3.Patients using antibiotics or corticosteroids 12hrs before appointment.
4. With non restorable and periodontal compromised teeth.
5.Teeth with calcified canals and weeping canals.

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 created by computer software (computerised sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 27054 0
Pakistan
State/province [1] 27054 0
kpk

Funding & Sponsors
Funding source category [1] 318926 0
Hospital
Name [1] 318926 0
Hospital (Khyber college of dentistry)
Country [1] 318926 0
Pakistan
Primary sponsor type
Individual
Name
Muhammad Abbas Yahya , work organization: Hospital (Khyber college of dentistry)
Address
Country
Pakistan
Secondary sponsor category [1] 321395 0
None
Name [1] 321395 0
Address [1] 321395 0
Country [1] 321395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317539 0
Khyber college of dentistry
Ethics committee address [1] 317539 0
Ethics committee country [1] 317539 0
Pakistan
Date submitted for ethics approval [1] 317539 0
20/09/2024
Approval date [1] 317539 0
24/09/2024
Ethics approval number [1] 317539 0

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

Contacts
Principal investigator
Name 141370 0
Dr Muhammad Abbas Yahya
Address 141370 0
Khyber college of dentistry, University campus, University of peshawar, University road, Peshawar, Khyber pakhtunkhuwa, Pakistan 25100
Country 141370 0
Pakistan
Phone 141370 0
+923459406300
Fax 141370 0
Email 141370 0
[email protected]
Contact person for public queries
Name 141371 0
Muhammad Abbas Yahya
Address 141371 0
Khyber college of dentistry, University campus, University of peshawar, University road, Peshawar, Khyber pakhtunkhuwa, Pakistan 25100
Country 141371 0
Pakistan
Phone 141371 0
+923459406300
Fax 141371 0
Email 141371 0
[email protected]
Contact person for scientific queries
Name 141372 0
Muhammad Abbas Yahya
Address 141372 0
Khyber college of dentistry, University campus, University of peshawar, University road, Peshawar, Khyber pakhtunkhuwa, Pakistan 25100
Country 141372 0
Pakistan
Phone 141372 0
+923459406300
Fax 141372 0
Email 141372 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, this study will not share individual participant data. All data will be analyzed and presented in aggregate form to ensure patient confidentiality and privacy.



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.