Periapical PeriodontitisNCT07710833
Effect of Intracanal Cryotherapy on Postoperative Endodontic Pain
A study testing root canal treatment and cryotherapy in people with Periapical Periodontitis and Asymptomatic Irreversible Pulpitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of cooled and room-temperature NaOCl irrigation on postoperative endodontic pain in single-rooted teeth diagnosed with asymptomatic irreversible pulpitis (AIP) or asymptomatic apical periodontitis (AAP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periapical Periodontitis, Asymptomatic Irreversible Pulpitis, Cryotherapy
- What is being tested?
- root canal treatment and cryotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2026to 3 Jul 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy patients with 18-70 years of age
- Single-rooted teeth with a single root canal, diagnosed with either AIP and normal periapical tissues or AAP.
- Pulpal and periapical diagnoses were established according to the American Association of Endodontists (AAE) [20] diagnostic terminology. Included teeth were categorized into 2 diagnostic groups: AIP with normal periapical tissues and AAP associated with pulp necrosis. AIP was provisionally diagnosed in teeth with extremely deep caries approximating or reaching the pulp, a positive response to cold testing (Dispodent, Nadu, India), and no clinical symptoms. Periapical radiographs showed a PAI score of 1 without periodontal ligament widening. The diagnosis was confirmed intraoperatively by persistent pulpal bleeding that remained uncontrolled after 10 minutes of application of a sterile cotton pellet moistened with 2.5% sodium hypochlorite. AAP was diagnosed in teeth with a PAI score of ≥3 in the absence of clinical symptoms. None of the included teeth exhibited tenderness to percussion. All periapical radiographs were obtained using a phosphor storage plate system and the paralleling technique (Myray parallel holder, NDental, Imola, Italy) under standardized exposure parameters (70 kV, 8 mA, 0.360 s).
- Exclusion Criteria: 1) Teeth with canal calcification, complex or atypical canal anatomy, root resorption, incomplete root development, or a history of endodontic treatment of the study tooth.
- 2) Teeth initially diagnosed with AIP in which pulpal bleeding was controlled within 10 min after access cavity preparation, as these teeth were considered eligible for vital pulp therapy.
- 3) Teeth initially diagnosed with AIP in which pulp necrosis was identified after access cavity preparation.
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- 4) Teeth in which root canal treatment could not be completed in a single visit.
- 5) Patients who had taken analgesics within 12 hours before the appointment or antibiotics within the previous month.
- 6) Teeth with periodontal probing depths >3 mm or clinical/radiographic signs of periodontal disease.
- 7) Teeth with insufficient coronal tooth structure to allow an adequate ferrule.
- 8) Pregnant or breastfeeding patients and patients with systemic conditions or regular medication use that could affect treatment outcomes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
Rize, Centre
About this study
Official title: Effect of Intracanal Cryotherapy on Endodontic Postoperative Pain in Teeth With Asymptomatic Irreversible Pulpitis and Asymptomatic Apical Periodontitis: A Four-Arm Randomized Controlled Trial
This study aimed to evaluate the effects of cooled and room-temperature NaOCl irrigation on postoperative endodontic pain in single-rooted teeth diagnosed with asymptomatic irreversible pulpitis (AIP) or asymptomatic apical periodontitis (AAP).
- Being tested
- root canal treatment and cryotherapy
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment and cryotherapyOther
All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience. Only 1 tooth per patient was included. Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine. After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically. Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy. Apical patency was maintained 1 mm beyond the working length using a size 10 K-file. Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle. NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal. Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1- Asymptomatic irreversible pulpitis - control | Other | 20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 was performed using this solution. Receives: Other: root canal treatment and cryotherapy |
| GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy | Experimental | For Group 2, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds. Receives: Other: root canal treatment and cryotherapy |
| GROUP 3- Asymptomatic apical periodontitis - control (n=33) | Other | 20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 and 3 was performed using this solution. Receives: Other: root canal treatment and cryotherapy |
| GROUP 4- Asymptomatic apical periodontitis - cryotherapy | Experimental | For Group 4, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds. Receives: Other: root canal treatment and cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time
Measured: During the first week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start11 May 2026
- Primary completion26 Jun 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medine Ciçek, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710833
- Sponsor's protocol ID
- 12
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracanal Cryotherapy on Endodontic Postoperative Pain in Teeth With Asymptomatic Irreversible Pulpitis and Asymptomatic Apical Periodontitis: A Four-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07710833
- Acronym / sponsor ID
- 12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 17 Jul 2026 (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 study aimed to evaluate the effects of cooled and room-temperature NaOCl irrigation on postoperative endodontic pain in single-rooted teeth diagnosed with asymptomatic irreversible pulpitis (AIP) or asymptomatic apical periodontitis (AAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP 1- Asymptomatic irreversible pulpitis - control | Other | Other: root canal treatment and cryotherapy20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 was performed using this solution. |
| GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy | Experimental | Other: root canal treatment and cryotherapyFor Group 2, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds. |
| GROUP 3- Asymptomatic apical periodontitis - control (n=33) | Other | Other: root canal treatment and cryotherapy20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C. Final irrigation in Groups 1 and 3 was performed using this solution. |
| GROUP 4- Asymptomatic apical periodontitis - cryotherapy | Experimental | Other: root canal treatment and cryotherapyFor Group 4, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator. The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use. A digital thermometer was used to verify that the solution remained at 2 °C. Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Systemically healthy patients with 18-70 years of age
- Single-rooted teeth with a single root canal, diagnosed with either AIP and normal periapical tissues or AAP.
- Pulpal and periapical diagnoses were established according to the American Association of Endodontists (AAE) [20] diagnostic terminology. Included teeth were categorized into 2 diagnostic groups: AIP with normal periapical tissues and AAP associated with pulp necrosis. AIP was provisionally diagnosed in teeth with extremely deep caries approximating or reaching the pulp, a positive response to cold testing (Dispodent, Nadu, India), and no clinical symptoms. Periapical radiographs showed a PAI score of 1 without periodontal ligament widening. The diagnosis was confirmed intraoperatively by persistent pulpal bleeding that remained uncontrolled after 10 minutes of application of a sterile cotton pellet moistened with 2.5% sodium hypochlorite. AAP was diagnosed in teeth with a PAI score of ≥3 in the absence of clinical symptoms. None of the included teeth exhibited tenderness to percussion. All periapical radiographs were obtained using a phosphor storage plate system and the paralleling technique (Myray parallel holder, NDental, Imola, Italy) under standardized exposure parameters (70 kV, 8 mA, 0.360 s).
- Exclusion Criteria: 1) Teeth with canal calcification, complex or atypical canal anatomy, root resorption, incomplete root development, or a history of endodontic treatment of the study tooth.
- 2) Teeth initially diagnosed with AIP in which pulpal bleeding was controlled within 10 min after access cavity preparation, as these teeth were considered eligible for vital pulp therapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| root canal treatment and cryotherapyAll endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience. Only 1 tooth per patient was included. Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine. After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically. Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy. Apical patency was maintained 1 mm beyond the working length using a size 10 K-file. Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle. NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal. Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute. | Other | GROUP 1- Asymptomatic irreversible pulpitis - control, GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy, GROUP 3- Asymptomatic apical periodontitis - control (n=33), GROUP 4- Asymptomatic apical periodontitis - cryotherapy |
Primary outcome
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time
Time frame: During the first week after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment and cryotherapy in people with Periapical Periodontitis and Asymptomatic Irreversible Pulpitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 11 inclusion and 0 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: finished, as of the sponsor's last update on 17 Jul 2026. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time (time frame: During the first week after treatment). 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 17 Jul 2026.