NCT05722704

Brief Summary

The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is: Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars? Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction. Researchers will compare \[Cryotherapy, occlusal reduction, and no intervention\] to see the intensity of post-endodontic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 24, 2024

Completed
Last Updated

December 24, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

January 23, 2023

Results QC Date

April 4, 2024

Last Update Submit

November 13, 2024

Conditions

Cryotherapy

Keywords

Post endodontic painCryotherapyOcclusal reductionRoot canal treatment

Outcome Measures

Primary Outcomes (4)

  • The Level of Post-endodontic Pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    6 hours

  • The Level of Post-endodontic Pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    24 hours

  • The Level of Post-endodontic Pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    48 hours

  • The Level of Post-endodontic Pain

    Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

    72 hours

Study Arms (3)

Cryotherapy

EXPERIMENTAL

Final irrigation with cold saline (2.5C-4C) without occlusal reduction

Procedure: Cryotherapy

Occlusal reduction

ACTIVE COMPARATOR

Normal room temperature saline irrigation protocol with occlusal reduction

Procedure: Occlusal reduction

Control

NO INTERVENTION

Normal room temperature saline irrigation protocol without occlusal reduction

Interventions

CryotherapyPROCEDURE

Final irrigation with cold saline (2.5C-4C) without occlusal reduction

Cryotherapy
Occlusal reductionPROCEDURE

Reduction of the functional and non-functional cusps

Occlusal reduction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-70 years
  • A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  • require endodontic therapy
  • Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  • Healthy patients without systemic disease
  • Permanent mature first mandibular molars

You may not qualify if:

  • Medically compromised patients
  • Pregnant patients
  • Teeth with incomplete apex formation
  • Teeth with calcified canals
  • Periapical abscess
  • Patients on antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Rania Zaarour
Organization
Gulf Medical University
dr.rania@gmu.ac.ae
+971 6 7431333

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Cell Biology and Researcher

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 10, 2023

Study Start

September 12, 2022

Primary Completion

September 12, 2023

Study Completion

December 12, 2023

Last Updated

December 24, 2024

Results First Posted

December 24, 2024

Record last verified: 2024-11

Locations

AE(1)