Asymptomatic Apical PeriodontitisNCT07850219
Effects of Intracanal Cryotherapy on Biomarkers and Postoperative Pain in Apical Periodontitis
A study of Asymptomatic Apical Periodontitis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical study will evaluate the effects of intracanal cryotherapy during root canal treatment in patients with asymptomatic apical periodontitis. The study will investigate whether the temperature of the final irrigation solution influences the biological inflammatory response and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to May 2028
- 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 between 18 and 65 years.
- Presence of a posterior tooth indicated for primary endodontic treatment (excluding retreatment cases).
- Diagnosis of apical periodontitis, meeting the following criteria:
- Necrotic pulp based on pulp vitality testing (negative cold test and/or electrical pulp test [EPT]).
- Periapical Index (PAI) ≥3 on periapical radiography or presence of periapical radiolucency on cone-beam computed tomography (CBCT).
- Asymptomatic or mildly symptomatic apical periodontitis (excluding cases of severe acute apical periodontitis).
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- Periodontal status meeting the following criteria:
- Probing depth ≤3 mm.
- Clinical attachment loss ≤2 mm.
- No periodontal pockets with bleeding on probing.
- The tooth to be treated must be suitable for isolation and sample collection.
- Participants must be able to understand the study procedures and provide informed consent.
Who cannot join
- Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or -corticosteroids within the previous 3 months.
- Presence of a systemic inflammatory or autoimmune disease.
- Diabetes (glycated hemoglobin [HbA1c] ≥6.5%) or uncontrolled metabolic disease.
- History of immunodeficiency or immunosuppressive therapy.
- Pregnancy or breastfeeding.
- Active smoking.
Show all 11Show fewer
- History of acute infection, febrile illness, or COVID-19 within the previous 3 -months.
- Retreatment cases.
- Presence of a fistula/sinus tract.
- Periodontal probing depth >3 mm.
- Tooth mobility ≥ Grade II.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duygu Değirmencioğlu Dr. Öğr. Üyesi, DDS, PhD contact
Turkey (Türkiye)1 site
Istanbul Medipol University Esenler SUAM
Istanbul
Rama Jaber, DDS, +90 539 853 1607 ext. +90, ramajaber200090@gmail.com
About this study
Official title: Evaluation of the Effect of Intracanal Cryotherapy in Root Canal Treatment Through Biomarker Analysis
This randomized controlled clinical study will evaluate the effects of intracanal cryotherapy during root canal treatment in patients with asymptomatic apical periodontitis. The study will investigate whether the temperature of the final irrigation solution influences the biological inflammatory response and postoperative pain.
Participants will be randomly assigned to one of three groups according to the temperature of distilled water used for final root canal irrigation: 2-4°C, 8-10°C, or 22-24°C. Periapical tissue fluid samples will be collected before and after the intervention and analyzed for inflammatory and tissue-response biomarkers, including IL-1β, TNF-α, RANKL/OPG, PGE2, TGF-β, and MMP-9. Postoperative pain and analgesic use will also be recorded during the first 7 days after treatment.
The study aims to determine whether intracanal cryotherapy can reduce the inflammatory response and postoperative pain associated with root canal treatment and whether these effects vary according to the temperature of the irrigation solution.
Read the detailed description
Apical periodontitis is an inflammatory condition of the periapical tissues associated with microbial infection of the root canal system. Inflammatory mediators released during the disease process contribute to periapical inflammation, tissue destruction, and bone resorption. Intracanal cryotherapy, involving the use of a cooled irrigation solution during root canal treatment, has been proposed as an approach to modulate the inflammatory response and reduce postoperative pain. However, the biological effects of different intracanal irrigation temperatures and the potential temperature-dependent response have not been fully characterized.
This prospective, randomized, controlled clinical study will investigate the biological and clinical effects of different irrigation temperatures in patients with asymptomatic apical periodontitis requiring root canal treatment. Participants will be randomly allocated to three groups according to the temperature of distilled water used for irrigation: 2-4°C, 8-10°C, or 22-24°C. The assigned temperature-controlled distilled-water irrigation protocol will be applied consistently during both the first and second treatment sessions. The temperature of the irrigation solution will be standardized and monitored according to the participant's allocated group throughout the irrigation procedure.
Root canal treatment will be performed using a standardized two-visit protocol. During the first visit, the tooth will be isolated with a rubber dam, working length will be determined, and chemomechanical root canal preparation will be performed according to a standardized protocol. The assigned temperature-controlled distilled-water irrigation method will be used during this session. A periapical tissue fluid (PTF) sample will be collected using sterile paper points and stored under appropriate conditions for subsequent biochemical analysis. Following completion of the first-session procedures, calcium hydroxide will be placed as an intracanal medicament.
During the second treatment session, the calcium hydroxide intracanal medicament will be removed and the same temperature-controlled distilled-water irrigation protocol assigned to the participant will again be applied. Thus, participants allocated to the 2-4°C, 8-10°C, or 22-24°C group will receive distilled-water irrigation at their respective assigned temperature during both treatment sessions. A second PTF sample will be collected using sterile paper points. Root canal treatment will then be completed with obturation using gutta-percha and an endodontic sealer.
The collected PTF samples will be analyzed using enzyme-linked immunosorbent assay (ELISA) to determine the levels of selected biomarkers, including interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), receptor activator of nuclear factor kappa-B ligand/osteoprotegerin (RANKL/OPG), prostaglandin E2 (PGE2), transforming growth factor-beta (TGF-β), and matrix metalloproteinase-9 (MMP-9). These biomarkers will be used to assess changes related to inflammatory activity, bone metabolism, tissue destruction, and tissue response associated with the different irrigation temperatures.
In addition to the biochemical assessment, postoperative pain will be evaluated using a visual analog scale (VAS), and analgesic consumption will be recorded during the first 7 days following treatment. The clinical and biochemical findings will be evaluated together to determine whether temperature-controlled intracanal irrigation influences the periapical inflammatory response and postoperative pain and whether these effects vary according to irrigation temperature.
By comparing three different irrigation temperatures and evaluating both molecular biomarkers and patient-reported postoperative pain, the study aims to provide evidence regarding the biological and clinical effects of intracanal cryotherapy and to determine whether a temperature-dependent response exists.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- Temperature-Controlled Intracanal Irrigation
- Keywords
- intracanal cryotherapy, Endodontic Irrigation, Periapical Biomarkers, Postoperative Pain, Inflammatory Biomarkers, Root Canal Treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-Controlled Intracanal IrrigationProcedure or surgery
Also called Intracanal Cryotherapy
Participants will receive temperature-controlled distilled-water intracanal irrigation during root canal treatment. According to computer-generated randomization, participants will be assigned to one of three irrigation-temperature groups: 2-4°C, 8-10°C, or 22-24°C. The assigned temperature-controlled distilled-water irrigation protocol will be applied during both treatment sessions. Irrigation conditions will be standardized across groups, with the irrigation temperature being the primary difference between the intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| 2-4°C Intracanal Cryotherapy | Experimental | Participants assigned to this group will receive temperature-controlled distilled-water intracanal irrigation at 2-4°C during both root canal treatment sessions according to the standardized irrigation protocol. Receives: Procedure: Temperature-Controlled Intracanal Irrigation |
| 8-10°C Intracanal Cryotherapy | Experimental | Participants assigned to this group will receive temperature-controlled distilled-water intracanal irrigation at 8-10°C during both root canal treatment sessions according to the standardized irrigation protocol. Receives: Procedure: Temperature-Controlled Intracanal Irrigation |
| 22-24°C Room-Temperature Control | Active comparator | Participants assigned to the control group will receive distilled-water intracanal irrigation at 22-24°C during both root canal treatment sessions according to the same standardized irrigation protocol. Receives: Procedure: Temperature-Controlled Intracanal Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Inflammatory Biomarker Levels
Changes in interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), receptor activator of nuclear factor kappa-B ligand (RANKL), osteoprotegerin (OPG), prostaglandin E2 (PGE2), transforming growth factor-beta (TGF-β), and matrix metalloproteinase-9 (MMP-9) levels in periapical tissue fluid (PTF) will be assessed using enzyme-linked immunosorbent assay (ELISA). Biomarker levels obtained during the first and second treatment sessions will be compared within and between the three irrigation-temperature groups to evaluate the biological response to temperature-controlled intracanal irrigation.
Measured: From the first treatment session to the second treatment session
Secondary outcomes (2)
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Participants will record their pain intensity after root canal treatment, and scores will be compared among the three irrigation-temperature groups.
Measured: Day 0, Day 1, Day 3, and Day 7 after the second treatment session.
Postoperative Analgesic Consumption
Postoperative analgesic consumption will be assessed as the total number of analgesic tablets consumed by each participant during the postoperative follow-up period. Participants will record analgesic use on a daily patient record form. The type and dose of analgesic used will also be documented for descriptive purposes. The total number of tablets consumed will be compared among the three irrigation-temperature groups.
Unit of measure: number of tablets.
Measured: From Day 0 through Day 7 after the second treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of three parallel groups according to the temperature of distilled water used for intracanal irrigation: 2-4°C, 8-10°C, or 22-24°C. Each participant will remain in the assigned temperature group during both treatment sessions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Degirmencioglu, Istanbul Medipol University Hospital
- Investigators
- Duygu Değirmencioğlu, Değirmencioğlu, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850219
- Sponsor's protocol ID
- E-10840098-50.04-1841
- Other IDs
- 401
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared due to participant confidentiality and data protection considerations. Study results will be reported in aggregated and anonymized form through scientific publications and presentations.
Publications
Vieyra JP, J Enriquez FJ, Acosta FO, Guardado JA. Reduction of postendodontic pain after one-visit root canal treatment using three irrigating regimens with different temperature. Niger J Clin Pract. 2019 Jan;22(1):34-40. doi: 10.4103/njcp.njcp_349_18.
PubMed 30666017Mourad A, Abdelsalam N, Fayyad D. Influence of intracanal cryotherapy on inflammatory mediators expression using different irrigation protocols: a randomized clinical trial. Saudi Endod J. 2021;11(2):246. doi:10.4103/sej.sej_203_20.
Vera 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Intracanal Cryotherapy in Root Canal Treatment Through Biomarker Analysis
- ClinicalTrials.gov ID
- NCT07850219
- Acronym / sponsor ID
- E-10840098-50.04-1841
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- intracanal cryotherapy, Endodontic Irrigation, Periapical Biomarkers, Postoperative Pain, Inflammatory Biomarkers, Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 30 Sep 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 randomized controlled clinical study will evaluate the effects of intracanal cryotherapy during root canal treatment in patients with asymptomatic apical periodontitis. The study will investigate whether the temperature of the final irrigation solution influences the biological inflammatory response and postoperative pain.
Participants will be randomly assigned to one of three groups according to the temperature of distilled water used for final root canal irrigation: 2-4°C, 8-10°C, or 22-24°C. Periapical tissue fluid samples will be collected before and after the intervention and analyzed for inflammatory and tissue-response biomarkers, including IL-1β, TNF-α, RANKL/OPG, PGE2, TGF-β, and MMP-9. Postoperative pain and analgesic use will also be recorded during the first 7 days after treatment.
The study aims to determine whether intracanal cryotherapy can reduce the inflammatory response and postoperative pain associated with root canal treatment and whether these effects vary according to the temperature of the irrigation solution.
Detailed description
Apical periodontitis is an inflammatory condition of the periapical tissues associated with microbial infection of the root canal system. Inflammatory mediators released during the disease process contribute to periapical inflammation, tissue destruction, and bone resorption. Intracanal cryotherapy, involving the use of a cooled irrigation solution during root canal treatment, has been proposed as an approach to modulate the inflammatory response and reduce postoperative pain. However, the biological effects of different intracanal irrigation temperatures and the potential temperature-dependent response have not been fully characterized.
This prospective, randomized, controlled clinical study will investigate the biological and clinical effects of different irrigation temperatures in patients with asymptomatic apical periodontitis requiring root canal treatment. Participants will be randomly allocated to three groups according to the temperature of distilled water used for irrigation: 2-4°C, 8-10°C, or 22-24°C. The assigned temperature-controlled distilled-water irrigation protocol will be applied consistently during both the first and second treatment sessions. The temperature of the irrigation solution will be standardized and monitored according to the participant's allocated group throughout the irrigation procedure.
Root canal treatment will be performed using a standardized two-visit protocol. During the first visit, the tooth will be isolated with a rubber dam, working length will be determined, and chemomechanical root canal preparation will be performed according to a standardized protocol. The assigned temperature-controlled distilled-water irrigation method will be used during this session. A periapical tissue fluid (PTF) sample will be collected using sterile paper points and stored under appropriate conditions for subsequent biochemical analysis. Following completion of the first-session procedures, calcium hydroxide will be placed as an intracanal medicament.
During the second treatment session, the calcium hydroxide intracanal medicament will be removed and the same temperature-controlled distilled-water irrigation protocol assigned to the participant will again be applied. Thus, participants allocated to the 2-4°C, 8-10°C, or 22-24°C group will receive distilled-water irrigation at their respective assigned temperature during both treatment sessions. A second PTF sample will be collected using sterile paper points. Root canal treatment will then be completed with obturation using gutta-percha and an endodontic sealer.
The collected PTF samples will be analyzed using enzyme-linked immunosorbent assay (ELISA) to determine the levels of selected biomarkers, including interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), receptor activator of nuclear factor kappa-B ligand/osteoprotegerin (RANKL/OPG), prostaglandin E2 (PGE2), transforming growth factor-beta (TGF-β), and matrix metalloproteinase-9 (MMP-9). These biomarkers will be used to assess changes related to inflammatory activity, bone metabolism, tissue destruction, and tissue response associated with the different irrigation temperatures.
In addition to the biochemical assessment, postoperative pain will be evaluated using a visual analog scale (VAS), and analgesic consumption will be recorded during the first 7 days following treatment. The clinical and biochemical findings will be evaluated together to determine whether temperature-controlled intracanal irrigation influences the periapical inflammatory response and postoperative pain and whether these effects vary according to irrigation temperature.
By comparing three different irrigation temperatures and evaluating both molecular biomarkers and patient-reported postoperative pain, the study aims to provide evidence regarding the biological and clinical effects of intracanal cryotherapy and to determine whether a temperature-dependent response exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups according to the temperature of distilled water used for intracanal irrigation: 2-4°C, 8-10°C, or 22-24°C. Each participant will remain in the assigned temperature group during both treatment sessions.
| Arm | Type | Receives |
|---|---|---|
| 2-4°C Intracanal Cryotherapy | Experimental | Procedure: Temperature-Controlled Intracanal IrrigationParticipants assigned to this group will receive temperature-controlled distilled-water intracanal irrigation at 2-4°C during both root canal treatment sessions according to the standardized irrigation protocol. |
| 8-10°C Intracanal Cryotherapy | Experimental | Procedure: Temperature-Controlled Intracanal IrrigationParticipants assigned to this group will receive temperature-controlled distilled-water intracanal irrigation at 8-10°C during both root canal treatment sessions according to the standardized irrigation protocol. |
| 22-24°C Room-Temperature Control | Active comparator | Procedure: Temperature-Controlled Intracanal IrrigationParticipants assigned to the control group will receive distilled-water intracanal irrigation at 22-24°C during both root canal treatment sessions according to the same standardized irrigation protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 65 years.
- Presence of a posterior tooth indicated for primary endodontic treatment (excluding retreatment cases).
- Diagnosis of apical periodontitis, meeting the following criteria:
- Necrotic pulp based on pulp vitality testing (negative cold test and/or electrical pulp test [EPT]).
- Periapical Index (PAI) ≥3 on periapical radiography or presence of periapical radiolucency on cone-beam computed tomography (CBCT).
Key exclusion criteria (11 listed)
- Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or -corticosteroids within the previous 3 months.
- Presence of a systemic inflammatory or autoimmune disease.
- Diabetes (glycated hemoglobin [HbA1c] ≥6.5%) or uncontrolled metabolic disease.
- History of immunodeficiency or immunosuppressive therapy.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Temperature-Controlled Intracanal IrrigationAlso: Intracanal CryotherapyParticipants will receive temperature-controlled distilled-water intracanal irrigation during root canal treatment. According to computer-generated randomization, participants will be assigned to one of three irrigation-temperature groups: 2-4°C, 8-10°C, or 22-24°C. The assigned temperature-controlled distilled-water irrigation protocol will be applied during both treatment sessions. Irrigation conditions will be standardized across groups, with the irrigation temperature being the primary difference between the intervention groups. | Procedure or surgery | 2-4°C Intracanal Cryotherapy, 22-24°C Room-Temperature Control, 8-10°C Intracanal Cryotherapy |
Primary outcome
Change in Periapical Inflammatory Biomarker Levels
Time frame: From the first treatment session to the second treatment session
Changes in interleukin-1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), receptor activator of nuclear factor kappa-B ligand (RANKL), osteoprotegerin (OPG), prostaglandin E2 (PGE2), transforming growth factor-beta (TGF-β), and matrix metalloproteinase-9 (MMP-9) levels in periapical tissue fluid (PTF) will be assessed using enzyme-linked immunosorbent assay (ELISA). Biomarker levels obtained during the first and second treatment sessions will be compared within and between the three irrigation-temperature groups to evaluate the biological response to temperature-controlled intracanal irrigation.
2 secondary outcomes
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time frame: Day 0, Day 1, Day 3, and Day 7 after the second treatment session.
Postoperative Analgesic Consumption
Time frame: From Day 0 through Day 7 after the second treatment session.
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 30 Sep 2026.
- Background: PubMed 30666017Vieyra JP, J Enriquez FJ, Acosta FO, Guardado JA. Reduction of postendodontic pain after one-visit root canal treatment using three irrigating regimens with different temperature. Niger J Clin Pract. 2019 Jan;22(1):34-40. doi: 10.4103/njcp.njcp_349_18.
- BackgroundMourad A, Abdelsalam N, Fayyad D. Influence of intracanal cryotherapy on inflammatory mediators expression using different irrigation protocols: a randomized clinical trial. Saudi Endod J. 2021;11(2):246. doi:10.4103/sej.sej_203_20.
- 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 (IPD) are not planned to be shared due to participant confidentiality and data protection considerations. Study results will be reported in aggregated and anonymized form through scientific publications and presentations.
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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.
Duygu Değirmencioğlu Dr. Öğr. Üyesi, DDS, PhD contact
Duygu Değirmencioğlu, Değirmencioğlu principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asymptomatic Apical Periodontitis, run by Medipol 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 12 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: opening soon, as of the sponsor's last update on 30 Sep 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 Duygu Değirmencioğlu Dr. Öğr. Üyesi, DDS, PhD (+90 545 918 56 76 ext. +90, dtduygudegirmencioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Periapical Inflammatory Biomarker Levels (time frame: From the first treatment session to the second treatment session). 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 NCT07850219, 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 30 Sep 2026.