NCT07850219

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026May 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1.6 years

First QC Date

September 22, 2026

Last Update Submit

September 29, 2026

Conditions

Asymptomatic Apical Periodontitis

Keywords

intracanal cryotherapyEndodontic IrrigationPeriapical BiomarkersPostoperative PainInflammatory BiomarkersRoot Canal Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the first treatment session to the second treatment session

Secondary Outcomes (2)

  • Postoperative Pain Intensity Assessed Using the Visual Analog Scale

    Day 0, Day 1, Day 3, and Day 7 after the second treatment session.

  • Postoperative Analgesic Consumption

    From Day 0 through Day 7 after the second treatment session.

Study Arms (3)

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.

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.

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.

Procedure: Temperature-Controlled Intracanal Irrigation

Interventions

Temperature-Controlled Intracanal IrrigationPROCEDURE

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.

Also known as: Intracanal Cryotherapy
2-4°C Intracanal Cryotherapy22-24°C Room-Temperature Control8-10°C Intracanal Cryotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Esenler SUAM

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 30666017BACKGROUND

  • Mourad 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

  • 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.

    PMID: 29079057BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Duygu Değirmencioğlu, Değirmencioğlu

    Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Değirmencioğlu Dr. Öğr. Üyesi, DDS, PhD

CONTACT

+90 545 918 56 76dtduygudegirmencioglu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be unaware of their assigned irrigation temperature (2-4°C, 8-10°C, or 22-24°C). The clinician performing the treatment and the personnel conducting the ELISA analyses will not be masked to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst prof

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 30, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)