Asymptomatic Apical PeriodontitisICE-PAINNCT07733700
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
A study testing Intracanal cryotherapy and Room-temperature saline irrigation in people with Asymptomatic Apical Periodontitis and Endodontic Retreatment, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis, Endodontic Retreatment, Cryotherapy
- What is being tested?
- Intracanal cryotherapy and Room-temperature saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, systemically healthy individuals (ASA I-II)
- Single-rooted mandibular premolar teeth with a previous root canal treatment, requiring non-surgical retreatment due to asymptomatic apical periodontitis
- Presence of periapical radiolucency (Periapical Index [PAI] ≥ 3)
- No antibiotic use within the past 1 month
- Willing to participate and has signed the informed consent form
Who cannot join
- Pregnancy or lactation
- Uncontrolled diabetes mellitus (HbA1c > 7%), diagnosed autoimmune disease, or receiving immunosuppressive therapy
- Systemic corticosteroid use within the past 3 months
- Body mass index (BMI) greater than 35 kg/m²
- Presence of acute infection (e.g., acute apical abscess or cellulitis)
- Conditions precluding retreatment, including advanced periodontal breakdown (clinical attachment loss > 5 mm), root resorption, perforation, or advanced canal calcification
Show all 11Show fewer
- Absence of an opposing (antagonist) tooth resulting in lack of functional occlusal contact
- Diagnosed chronic pain syndrome or currently receiving active psychiatric treatment
- Smoking more than 10 cigarettes per day
- Use of analgesics or NSAIDs within the past 24 hours
- Antibiotic use within the past 1 month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Alanya Alaaddin Keykubat University
Alanya, Antalya
Hatice Büyüközer Özkan, hatice.ozkan@alanya.edu.tr
Gizem Pelin Yoldaş, +90 5462446097, pelin.yoldas@alanya.edu.tr
About this study
Official title: Evaluation of the Relationship Between PGE2, NGF, and Postoperative Pain in Patients With and Without Intracanal Cryotherapy in Single-visit Endodontic Retreatment
This prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. A total of 100 patients (18-65 years, systemically healthy, ASA I-II) requiring non-surgical retreatment of a single-rooted mandibular premolar tooth will be randomly assigned via computer-generated randomization to one of two equal groups (n=50 each): a cryotherapy group, receiving intracanal final irrigation with sterile saline cooled to 2.5°C for 5 minutes, and a control group, receiving the same irrigation protocol with saline at room temperature (20-22°C). Salivary nerve growth factor (NGF) and gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels will be measured by ELISA at baseline (T0), 24 hours (T1), and 72 hours (T2). Postoperative pain will be assessed using a visual analog scale (VAS, 0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour VAS score as the primary comparison point. Rescue analgesic (paracetamol) consumption will also be recorded and compared between groups. The study aims to determine whether intracanal cryotherapy lowers postoperative pain and biomarker levels compared to standard-temperature irrigation, and to evaluate the correlation between PGE2/NGF levels and pain intensity.
Read the detailed description
Postoperative pain following endodontic retreatment is associated with periapical inflammation mediated by prostaglandin E2 (PGE2) and nerve growth factor (NGF). Intracanal cryotherapy has been proposed to reduce postoperative pain through local hypothermia-induced vasoconstriction, neuropraxia, and reduced metabolic and inflammatory mediator activity. While prior studies have examined cryotherapy's effect on postoperative pain, no randomized controlled trial has jointly measured PGE2 and NGF using minimally invasive sampling methods (GCF and saliva) in the context of single-visit retreatment.
Eligible patients will be systemically healthy adults (18-65 years, ASA I-II) with a single-rooted mandibular premolar tooth requiring non-surgical retreatment due to a previously inadequate root canal treatment, presenting with asymptomatic apical periodontitis and periapical radiolucency (PAI ≥ 3). Key exclusion criteria include pregnancy or lactation, uncontrolled diabetes mellitus (HbA1c > 7%), autoimmune disease, immunosuppressive therapy, systemic corticosteroid use within the past 3 months, BMI > 35 kg/m², acute infection (abscess/cellulitis), advanced periodontal breakdown, heavy smoking (>10 cigarettes/day), recent analgesic/NSAID or antibiotic use, and chronic pain syndromes.
Patients will be randomly allocated (computer-generated randomization, sealed envelopes) to one of two parallel groups:
Group A (Cryotherapy): Following standard non-surgical retreatment instrumentation, final intracanal irrigation with sterile saline cooled to 2.5°C, 20 mL, over 5 minutes.
Group B (Control): Identical protocol using sterile saline at room temperature (20-22°C), 20 mL, over 5 minutes.
All treatments will be performed in a single visit by one calibrated operator following a standardized protocol; the two groups differ only in irrigation temperature. Given the nature of the intervention, the operator cannot be blinded; however, laboratory personnel analyzing saliva/GCF samples and statisticians will remain blinded to group allocation (single-blind design).
Outcome measures:
Primary: Postoperative pain intensity measured by VAS (0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour time point as the primary comparison.
Secondary: Salivary NGF levels (ELISA) and GCF PGE2 levels (ELISA) at baseline (T0), 24 hours (T1), and 72 hours (T2); rescue analgesic (paracetamol 500 mg, oral, as needed) consumption over 7 days; and correlation between biomarker levels and VAS pain scores.
Each patient will be followed for a total of 7 days. Saliva and GCF samples will be collected between 08:00-10:00 to minimize circadian variation. Sample size was calculated using G*Power 3.1.9.7 (repeated-measures ANOVA, 80% power, α=0.05, f=0.25), yielding a minimum of 34 participants per group; accounting for an estimated 20% dropout rate, 50 patients per group (100 total) will be enrolled. Statistical significance will be set at p<0.05. The study is sponsored and funded internally by Alanya Alaaddin Keykubat University, with no external funding or industry sponsorship.
- Being tested
- Intracanal cryotherapy, Room-temperature saline irrigation
- Keywords
- Intracanal Cryotherapy, Postoperative Pain, Prostaglandin E2, Nerve Growth Factor, Endodontic Retreatment, Gingival Crevicular Fluid, Saliva Biomarkers
- Medical subject headings
- Pain, Postoperative, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracanal cryotherapyProcedure or surgery
Also called Cold Saline Irrigation
Final intracanal irrigation with sterile 0.9% saline solution cooled to 2.5°C (using an ice-water bath), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment.
Room-temperature saline irrigationProcedure or surgery
Final intracanal irrigation with sterile 0.9% saline solution at room temperature (20-22°C), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment - identical protocol to the cryotherapy group except for irrigant temperature.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy group | Experimental | Following standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) cooled to 2.5°C, 20 mL, over 5 minutes, in a single visit. Receives: Procedure: Intracanal cryotherapy |
| Control group | Active comparator | Following the same standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) at room temperature (20-22°C), 20 mL, over 5 minutes, in a single visit. Receives: Procedure: Room-temperature saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (VAS score)
Postoperative pain intensity assessed using a Visual Analog Scale (VAS, 0-100 mm, where 0 = no pain and 100 = worst imaginable pain), self-reported by patients. The 24-hour time point is designated as the primary comparison between the cryotherapy and control groups.
Measured: Baseline, then at 6, 12, 24, 48, and 72 hours and on Day 7 postoperatively (primary comparison at 24 hours)
Secondary outcomes (2)
Salivary nerve growth factor (NGF) levels
Salivary NGF concentration measured by ELISA to assess the neurotrophic/inflammatory biomarker response between cryotherapy and control groups.
Measured: Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively
Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels
PGE2 concentration in gingival crevicular fluid measured by ELISA to assess the inflammatory biomarker response between cryotherapy and control groups.
Measured: Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start22 Sep 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Apical 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice BÜYÜKÖZER ÖZKAN, Alanya Alaaddin Keykubat University
- Investigators
- Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Study director, Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of EndodonticsBilge Karcı, Associate Professor, Principal investigator, Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of PeriodontologyErtan Küçüksayan, Associate Professor, Principal investigator, Alanya Alaaddin Keykubat University, Faculty of Medicine, Department of BiochemistryGizem Pelin Yoldaş, Research Assistant, Principal investigator, Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733700
- Sponsor's protocol ID
- ALKU-EC-2026-44
- Acronym
- ICE-PAIN
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team due to participant confidentiality commitments outlined in the informed consent process. Biological samples (saliva and gingival crevicular fluid) and associated data are used solely for this study's biomarker analyses (PGE2, NGF via ELISA), are not banked for future research, and will be destroyed 5 years after study completion in accordance with data protection regulations (Turkish Law No. 6698 on the Protection of Personal Data, KVKK). Aggregate, de-identified results will be reported in accordance with CONSORT 2010 guidelines and made available through the study's publication(s).
Publications
Kaya Mumcu A, Tuzcu E, Kurnaz S, Kiraz G. Evaluation of the effect of intracanal cryotherapy on postoperative pain after retreatment: a randomized controlled clinical trial. Clin Oral Investig. 2025 Jun 25;29(7):355. doi: 10.1007/s00784-025-06435-w.
PubMed 40560202Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30.
PubMed 37222468Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
PubMed 29079057
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between PGE2, NGF, and Postoperative Pain in Patients With and Without Intracanal Cryotherapy in Single-visit Endodontic Retreatment
- ClinicalTrials.gov ID
- NCT07733700
- Acronym / sponsor ID
- ICE-PAIN / ALKU-EC-2026-44
- Keywords
- Intracanal Cryotherapy, Postoperative Pain, Prostaglandin E2, Nerve Growth Factor, Endodontic Retreatment, Gingival Crevicular Fluid, Saliva Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 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 prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. A total of 100 patients (18-65 years, systemically healthy, ASA I-II) requiring non-surgical retreatment of a single-rooted mandibular premolar tooth will be randomly assigned via computer-generated randomization to one of two equal groups (n=50 each): a cryotherapy group, receiving intracanal final irrigation with sterile saline cooled to 2.5°C for 5 minutes, and a control group, receiving the same irrigation protocol with saline at room temperature (20-22°C). Salivary nerve growth factor (NGF) and gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels will be measured by ELISA at baseline (T0), 24 hours (T1), and 72 hours (T2). Postoperative pain will be assessed using a visual analog scale (VAS, 0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour VAS score as the primary comparison point. Rescue analgesic (paracetamol) consumption will also be recorded and compared between groups. The study aims to determine whether intracanal cryotherapy lowers postoperative pain and biomarker levels compared to standard-temperature irrigation, and to evaluate the correlation between PGE2/NGF levels and pain intensity.
Detailed description
Postoperative pain following endodontic retreatment is associated with periapical inflammation mediated by prostaglandin E2 (PGE2) and nerve growth factor (NGF). Intracanal cryotherapy has been proposed to reduce postoperative pain through local hypothermia-induced vasoconstriction, neuropraxia, and reduced metabolic and inflammatory mediator activity. While prior studies have examined cryotherapy's effect on postoperative pain, no randomized controlled trial has jointly measured PGE2 and NGF using minimally invasive sampling methods (GCF and saliva) in the context of single-visit retreatment.
Eligible patients will be systemically healthy adults (18-65 years, ASA I-II) with a single-rooted mandibular premolar tooth requiring non-surgical retreatment due to a previously inadequate root canal treatment, presenting with asymptomatic apical periodontitis and periapical radiolucency (PAI ≥ 3). Key exclusion criteria include pregnancy or lactation, uncontrolled diabetes mellitus (HbA1c > 7%), autoimmune disease, immunosuppressive therapy, systemic corticosteroid use within the past 3 months, BMI > 35 kg/m², acute infection (abscess/cellulitis), advanced periodontal breakdown, heavy smoking (>10 cigarettes/day), recent analgesic/NSAID or antibiotic use, and chronic pain syndromes.
Patients will be randomly allocated (computer-generated randomization, sealed envelopes) to one of two parallel groups:
Group A (Cryotherapy): Following standard non-surgical retreatment instrumentation, final intracanal irrigation with sterile saline cooled to 2.5°C, 20 mL, over 5 minutes.
Group B (Control): Identical protocol using sterile saline at room temperature (20-22°C), 20 mL, over 5 minutes.
All treatments will be performed in a single visit by one calibrated operator following a standardized protocol; the two groups differ only in irrigation temperature. Given the nature of the intervention, the operator cannot be blinded; however, laboratory personnel analyzing saliva/GCF samples and statisticians will remain blinded to group allocation (single-blind design).
Outcome measures:
Primary: Postoperative pain intensity measured by VAS (0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour time point as the primary comparison.
Secondary: Salivary NGF levels (ELISA) and GCF PGE2 levels (ELISA) at baseline (T0), 24 hours (T1), and 72 hours (T2); rescue analgesic (paracetamol 500 mg, oral, as needed) consumption over 7 days; and correlation between biomarker levels and VAS pain scores.
Each patient will be followed for a total of 7 days. Saliva and GCF samples will be collected between 08:00-10:00 to minimize circadian variation. Sample size was calculated using G*Power 3.1.9.7 (repeated-measures ANOVA, 80% power, α=0.05, f=0.25), yielding a minimum of 34 participants per group; accounting for an estimated 20% dropout rate, 50 patients per group (100 total) will be enrolled. Statistical significance will be set at p<0.05. The study is sponsored and funded internally by Alanya Alaaddin Keykubat University, with no external funding or industry sponsorship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy group | Experimental | Procedure: Intracanal cryotherapyFollowing standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) cooled to 2.5°C, 20 mL, over 5 minutes, in a single visit. |
| Control group | Active comparator | Procedure: Room-temperature saline irrigationFollowing the same standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) at room temperature (20-22°C), 20 mL, over 5 minutes, in a single visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years, systemically healthy individuals (ASA I-II)
- Single-rooted mandibular premolar teeth with a previous root canal treatment, requiring non-surgical retreatment due to asymptomatic apical periodontitis
- Presence of periapical radiolucency (Periapical Index [PAI] ≥ 3)
- No antibiotic use within the past 1 month
- Willing to participate and has signed the informed consent form
Key exclusion criteria (11 listed)
- Pregnancy or lactation
- Uncontrolled diabetes mellitus (HbA1c > 7%), diagnosed autoimmune disease, or receiving immunosuppressive therapy
- Systemic corticosteroid use within the past 3 months
- Body mass index (BMI) greater than 35 kg/m²
- Presence of acute infection (e.g., acute apical abscess or cellulitis)
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 |
|---|---|---|
| Intracanal cryotherapyAlso: Cold Saline IrrigationFinal intracanal irrigation with sterile 0.9% saline solution cooled to 2.5°C (using an ice-water bath), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment. | Procedure or surgery | Cryotherapy group |
| Room-temperature saline irrigationFinal intracanal irrigation with sterile 0.9% saline solution at room temperature (20-22°C), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment - identical protocol to the cryotherapy group except for irrigant temperature. | Procedure or surgery | Control group |
Primary outcome
Postoperative pain intensity (VAS score)
Time frame: Baseline, then at 6, 12, 24, 48, and 72 hours and on Day 7 postoperatively (primary comparison at 24 hours)
Postoperative pain intensity assessed using a Visual Analog Scale (VAS, 0-100 mm, where 0 = no pain and 100 = worst imaginable pain), self-reported by patients. The 24-hour time point is designated as the primary comparison between the cryotherapy and control groups.
2 secondary outcomes
Salivary nerve growth factor (NGF) levels
Time frame: Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively
Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels
Time frame: Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 40560202Kaya Mumcu A, Tuzcu E, Kurnaz S, Kiraz G. Evaluation of the effect of intracanal cryotherapy on postoperative pain after retreatment: a randomized controlled clinical trial. Clin Oral Investig. 2025 Jun 25;29(7):355. doi: 10.1007/s00784-025-06435-w.
- Background: PubMed 37222468Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30.
- Background: PubMed 29079057Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team due to participant confidentiality commitments outlined in the informed consent process. Biological samples (saliva and gingival crevicular fluid) and associated data are used solely for this study's biomarker analyses (PGE2, NGF via ELISA), are not banked for future research, and will be destroyed 5 years after study completion in accordance with data protection regulations (Turkish Law No. 6698 on the Protection of Personal Data, KVKK). Aggregate, de-identified results will be reported in accordance with CONSORT 2010 guidelines and made available through the study's publication(s).
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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.
Hatice BÜYÜKÖZER ÖZKAN, Associate Professor study director
Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Endodontics
Bilge Karcı, Associate Professor principal investigator
Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology
Ertan Küçüksayan, Associate Professor principal investigator
Alanya Alaaddin Keykubat University, Faculty of Medicine, Department of Biochemistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracanal cryotherapy and Room-temperature saline irrigation in people with Asymptomatic Apical Periodontitis and Endodontic Retreatment, run by Alanya Alaaddin Keykubat 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Büyüközer Özkan, Associate Professor (+90 530 971 02 52, hatice.ozkan@alanya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (VAS score) (time frame: Baseline, then at 6, 12, 24, 48, and 72 hours and on Day 7 postoperatively (primary comparison at 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07733700, which also lists 3 linked publications.
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 27 Oct 2026.