Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain

NCT06090500 | Completed

• 1 other identifier: FDASU 1234
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis. The main question it aims to answer is: Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment preceded by preoperative injection of cold saline (cryotherapy) or preoperative injection of anti-inflammatory drugs Researchers will compare \[Cryotherapy, Non steroidal anti-inflammatory drugs, steroids and no intervention\] to see the intensity of post-endodontic pain.

Conditions

Post-endodontic Pain

Outcome Measures

Primary Outcomes (4)

• the level of post-endodontic pain

  Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)

  6 hours after completion of endodontic treatment

• the level of post-endodontic pain

  Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)

  24 hours after completion of endodontic treatment

• the level of post-endodontic pain

  Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)

  48 hours after completion of endodontic treatment

• the level of post-endodontic pain

  Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)

  72 hours after completion of endodontic treatment

Study Arms (4)

Submucosal Cryotherapy

EXPERIMENTAL

preoperative submucosal infiltration injection of (2.5C-5C) cold saline

Procedure: Cryotherapy

Submucosal NSAIDs

ACTIVE COMPARATOR

preoperative submucosal infiltration injection of Diclofenac sodium

Procedure: Diclofenac sodium

Submucosal corticosteroids

ACTIVE COMPARATOR

preoperative submucosal infiltration injection of dexamethasone

Procedure: Dexamethasone sodium phosphate

Control

NO INTERVENTION

no preoperative injection apart from the normal anaesthetic routine

Interventions

Cryotherapy PROCEDURE

preoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius)

Submucosal Cryotherapy

Diclofenac sodium PROCEDURE

preoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml)

Submucosal NSAIDs

Dexamethasone sodium phosphate PROCEDURE

preoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml)

Submucosal corticosteroids

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Egyptian healthy both gender patients (Category: American Society of Anesthesiologists ASA class I)
• Patients age (18- 50) years old.
• Maxillary premolar teeth diagnosed with symptomatic irreversible pulpitis.
• No clinical or radiographic evidence of periapical nor periodontal pathosis.
• Compliant patient.

You may not qualify if:

• The vulnerable group; prisoners, pregnant females, mentally ill, severe systemic diseases, psychological diseases, TMJ problems.
• Analgesics or anti-inflammatory drugs taken within 24 h before the intervention.
• Over instrumentation during treatment.
• Long-term use of corticosteroids.
• Access revealing necrotic tooth indicating a false positive diagnosis.
• Sensitivity to any of the pharmaceuticals intended to be used in this study.
• Intra operative complications such as canal calcification, or loss of apical Patency.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Cryotherapy; Diclofenac; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Therapeutics; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant in the department of endodontics faculty of dentistry ASU

Model Details: submucosal injection of cold saline 2 to 5 degrees celsius for cryotherapy

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 19, 2023
• Study Start: March 20, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 30, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

EG (1)