Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000626460
Ethics application status
Approved
Date submitted
3/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing pain after root canal treatment using cold saline (cryotherapy) versus normal temperature saline in adults with painful tooth infection
Scientific title
A randomized controlled trial comparing the frequency of postoperative pain following intracanal cryotherapy versus room temperature saline irrigation in single-visit root canal treatment of teeth with symptomatic apical periodontitis
Secondary ID [1] 314353 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative dental pain 337335 0
Symptomatic apical periodontitis 337334 0
Condition category
Condition code
Anaesthesiology 333959 333959 0 0
Pain management
Oral and Gastrointestinal 333722 333722 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
Brief Name:
Arm 1: Intracanal Cryotherapy (Cold Saline Irrigation)
Arm 2: Room Temperature Saline Irrigation (Control)
Arm 1 – Intracanal Cryotherapy
• Description: Patients will receive final irrigation with 10 mL of cold (1.5°C–2.5°C) 0.9% normal saline delivered over 5 minutes.
• Mode of Delivery: Irrigation to working length using a 30-gauge double-side vented needle.
• Frequency & Duration: Single irrigation session during a single-visit root canal therapy.
• Delivery Personnel: Performed by the principal investigator (FCPS II Endodontics resident) under supervision of a consultant endodontist.
• Setting: Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Swat, Pakistan.
• Support Activities: Syringes containing saline are pre-cooled in a digitally monitored refrigerator and retrieved immediately before use.
• Personalization or Adaptation: Not applicable.
• Intervention Fidelity: The procedure is standardized using defined volumes, time, and needle type; administered under supervision for consistency.
Intervention code [1] 330967 0
Treatment: Surgery
Comparator / control treatment
Arm 2 – Room Temperature Saline (Control Group)
• Description: Final irrigation with 10 mL of 0.9% normal saline at room temperature (~22°C–25°C), also delivered over 5 minutes.
• Mode of Delivery: Identical to Arm 1, using 30-gauge double-side vented needle.
• Frequency & Duration: Single irrigation session during a single-visit root canal therapy.
• Delivery Personnel: Same as Arm 1.
• Setting: Same as Arm 1.
• Control Measures: Patients are blinded to group allocation; interventions are performed identically except for saline temperature.
Control group
Active

Outcomes
Primary outcome [1] 341317 0
Proportion of participants experiencing postoperative pain
Timepoint [1] 341317 0
Primary timepoint: 24 hours post-treatment
Secondary outcome [1] 447100 0
Mean intensity of postoperative pain
Timepoint [1] 447100 0
6 hours, 24 hours, and 48 hours after completion of root canal therapy

Eligibility
Key inclusion criteria
1. Patients with ages ranging from 16 to 50 years.
2. Teeth indicated for single-visit root canal treatment after history, examination and radiographic findings of no periapical radiolucency and normal root anatomy.
3. Patients with good general health. (no medical history like diabetes mellitus and hypertension etc)
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of allergy to local anesthetic agents or endodontic materials.
2. Presence of progressive periodontal disease after clinical and radiographic diagnosis like tooth mobility, deep pocketing associated with attachment loss and bone loss.
3. Nonrestorable tooth, or any signs of external and internal root resorption on a radiograph.
4. Retreatment cases diagnosed after clinical and radiographic examination.
5. Immature roots in radiographs due to unpredictable outcome.

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 concealment will be ensured using the sealed opaque envelope method. After confirming participant eligibility, the enrolling investigator will open a sequentially numbered, sealed opaque envelope containing the group assignment. These envelopes will be prepared in advance by an independent third party, ensuring that the person determining eligibility is unaware of group allocation at the time of inclusion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used to generate the random order for the allocation of subjects into the intervention and control groups. This will be done by a lottery method, ensuring that each participant has an equal chance of being assigned to either group.
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
19/08/2025
Actual
Date of last participant enrolment
Anticipated
25/02/2026
Actual
Date of last data collection
Anticipated
25/03/2026
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment outside Australia
Country [1] 27031 0
Pakistan
State/province [1] 27031 0

Funding & Sponsors
Funding source category [1] 318872 0
Self funded/Unfunded
Name [1] 318872 0
Sheraz Muhammad Khan (saidu college of dentistry, operative department)
Country [1] 318872 0
Pakistan
Primary sponsor type
University
Name
saidu college of dentistry
Address
Country
Pakistan
Secondary sponsor category [1] 321333 0
Hospital
Name [1] 321333 0
saidu medical college
Address [1] 321333 0
Country [1] 321333 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317485 0
saidu medical college ethical review board
Ethics committee address [1] 317485 0
Ethics committee country [1] 317485 0
Pakistan
Date submitted for ethics approval [1] 317485 0
01/03/2024
Approval date [1] 317485 0
13/03/2024
Ethics approval number [1] 317485 0

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

Contacts
Principal investigator
Name 141206 0
Dr Sheraz Muhammad Khan
Address 141206 0
Operative dentistry department, saidu dental college, saidu shareef , swat, Khyber Pakhtoon khwa-19200, Pakistan.
Country 141206 0
Pakistan
Phone 141206 0
+923089252228
Fax 141206 0
Email 141206 0
[email protected]
Contact person for public queries
Name 141207 0
Sheraz Muhammad Khan
Address 141207 0
Operative dentistry department, saidu dental college, saidu shareef , swat, Khyber Pakhtunkhwa- 19200, Pakistan
Country 141207 0
Pakistan
Phone 141207 0
+923089252228
Fax 141207 0
Email 141207 0
[email protected]
Contact person for scientific queries
Name 141208 0
Sheraz Muhammad Khan
Address 141208 0
Operative dentistry department, saidu dental college, saidu shareef , swat, Khyber PakhtoonKhwa-19200, Pakistan
Country 141208 0
Pakistan
Phone 141208 0
+923089252228
Fax 141208 0
Email 141208 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.