Post Operative PainPhase 2CyNCT06785753
Effectiveness of Cryotherapy on Endodontic Pain
A Phase 2 study testing Irrigation Solution in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Irrigation Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Nov 2024to 8 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis
- maxillary or mandibular single rooted teeth
- systemically healthy patients
- patients having pain score < 8
Who cannot join
- patients on preoperative analgesics or antibiotics within past 12 hours
- teeth with calcified canals and previously treated teeth
- tooth with immature apices or resorption
- patients allergic to local anesthesia
- pregnant or lactating mothers
- patients who are immunocompromised .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
Hira Amjad, BDS, 03345294071, anmolamjad03@gmail.com
About this study
Official title: Effectiveness of Intracanal Cryotherapy on Post Operative Pain After Root Canal Therapy in Patients with Symptomatic Apical Periodontitis
This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis
Read the detailed description
Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .
patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.
patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10
patients with pain score <8 will be considered
Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done
Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling
Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph
Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .
final irrigation will be performed using 17% EDTA and 5.25% NaOCl
Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C
the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.
Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer
Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement
each patient will be given instruction to acess the post operative pain .
- Conditions
- Post Operative Pain
- Being tested
- Irrigation Solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation SolutionDrug
Also called normal saline irrigant
normal saline will be used as irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| normal saline group | Experimental | In control group , canals will be irrigated with 5ml of normal saline at room temperature Receives: Drug: Irrigation Solution |
| cryotherapy (cold saline group) | Experimental | in cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C Receives: Drug: Irrigation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain after root canal treatment
post operative pain will be assessed using visual analogue scale ( VAS) from 0-10 each patient will be given instruction to access the post operative pain . it will be carried out using a questionnaire.
VAS 0-1 = No pain 2-3 = mild pain 4-6 = moderate pain 7-10 = severe pain pain recording will be done at 6 hrs , 24 hrs, 48hrs and 72 hrs. ( participants to be contacted by investigator at each point to check on them and remind them to record their pain ). The given questionnaire shall be collected when the participant comes for final restoration after 1 week
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start7 Nov 2024
- Primary completion7 May 2025 (estimated)
- Study completion8 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Amjad, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Hira Amjad, BDS, Principal investigator, Armed Forces Institude Of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785753
- Sponsor's protocol ID
- Cryotherapy
- Acronym
- Cy
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2023
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intracanal Cryotherapy on Post Operative Pain After Root Canal Therapy in Patients with Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06785753
- Acronym / sponsor ID
- Cy / Cryotherapy
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (estimated)
- Study completion
- 8 May 2025 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis
Detailed description
Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .
patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.
patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10
patients with pain score <8 will be considered
Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done
Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling
Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph
Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .
final irrigation will be performed using 17% EDTA and 5.25% NaOCl
Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C
the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.
Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer
Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement
each patient will be given instruction to acess the post operative pain .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline group | Experimental | Drug: Irrigation SolutionIn control group , canals will be irrigated with 5ml of normal saline at room temperature |
| cryotherapy (cold saline group) | Experimental | Drug: Irrigation Solutionin cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis
- maxillary or mandibular single rooted teeth
- systemically healthy patients
- patients having pain score < 8
Key exclusion criteria (6 listed)
- patients on preoperative analgesics or antibiotics within past 12 hours
- teeth with calcified canals and previously treated teeth
- tooth with immature apices or resorption
- patients allergic to local anesthesia
- pregnant or lactating mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation SolutionAlso: normal saline irrigantnormal saline will be used as irrigation solution | Drug | cryotherapy (cold saline group), normal saline group |
Primary outcome
post operative pain after root canal treatment
Time frame: 1 week
post operative pain will be assessed using visual analogue scale ( VAS) from 0-10 each patient will be given instruction to access the post operative pain . it will be carried out using a questionnaire. VAS 0-1 = No pain 2-3 = mild pain 4-6 = moderate pain 7-10 = severe pain pain recording will be done at 6 hrs , 24 hrs, 48hrs and 72 hrs. ( participants to be contacted by investigator at each point to check on them and remind them to record their pain ). The given questionnaire shall be collected when the participant comes for final restoration after 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hira Amjad, BDS principal investigator
Armed Forces Institude Of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irrigation Solution in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Amjad, BDS (03345294071, anmolamjad03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain after root canal treatment (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.