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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05041738
• Other study ID #: ENDO 3-3-5 8/9/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: Toka M Ezzat, B.D.S. (Cairo University)
• Phone: 01005137002
• Email: toka.ezzat[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Intraoral Cryotherapy
small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth
• Intracanal Cryotherapy
Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6. Review. — View Citation

Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of analgesics taken by the patient	Number of analgesics taken by the patient after endodontic treatment.	Up to 72 hours
Primary	Postoperative pain assessed using Visual Analogue scale	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."	6 hours post treatment
Primary	Postoperative pain assessed using Visual Analogue scale	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."	12 hours post treatment
Primary	Postoperative pain assessed using Visual Analogue scale	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."	24 hours post treatment
Secondary	Postoperative pain assessed using Visual Analogue scale	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."	48 hours post treatment
Secondary	Postoperative pain assessed using Visual Analogue scale	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."	72 hours post treatment