Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05041738

Enrollment

Registered

2021-09-13

Start date

2021-10-01

Completion date

2022-10-01

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis

Interventions

PROCEDUREIntraoral Cryotherapy

small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth

PROCEDUREIntracanal Cryotherapy

Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 20 Years

Healthy volunteers

Yes

Inclusion criteria

Systemically healthy patient (ASA I or II). Mandibular first molar teeth with: * Preoperative sharp pain and symptomatic apical periodontitis * Absence or slight widening in the periodontal ligament (PDL). * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) . * Positive response to percussion test

Exclusion criteria

1. Medically compromised patients. 2. Pregnant women. 3. Patients reporting bruxism or clenching. 4. Patients allergic to ciprofloxacin or metronidazole. 5. Teeth associated with acute periapical abscess and/or swelling. 6. Greater than grade I mobility or pocket depth greater than 5mm. 7. Size of periapical radiolucency is greater than 8 mm. 8. No restorability: Hopeless tooth. 9. Immature teeth. 10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain assessed using Visual Analogue scale	6 hours post treatment	Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain.

Secondary

Measure	Time frame	Description
Postoperative pain assessed using Visual Analogue scale	48 hours post treatment	Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain.

Other

Measure	Time frame	Description
Number of analgesics taken by the patient	Up to 72 hours	Number of analgesics taken by the patient after endodontic treatment.

Contacts

Primary ContactToka M Ezzat, B.D.S. (Cairo University)

toka.ezzat@dentistry.cu.edu.eg01005137002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026