Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

NCT04733326 | Completed Phase 1

• 1 other identifier: CairoU0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the:

• Intensity of post-operative pain in patients with symptomatic irreversible pulpitis
• Reduction of expression of Interleukin-8 (IL-8) post-instrumentation using ELISA
• The analgesic intake following endodontic treatment for post-operative pain relief.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Intensity of post-operative pain

  using the visual analogue scale

  24 hours following endoodnitc treatment

Secondary Outcomes (2)

• IL-8 level

  during root canal treatment

• Analgesic intake

  first 24 hours after completion of endodontic treatment

Study Arms (3)

Cryothrapy

EXPERIMENTAL

5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

Other: Cryotherapy

Ketroloc tromethamine

EXPERIMENTAL

2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

Drug: Ketorolac Tromethamine

Saline at room temperature

PLACEBO COMPARATOR

30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.

Other: Saline

Interventions

Ketorolac Tromethamine DRUG

final rinse with non-steriodal anti-inflammatory drug during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis

Also known as: Ketolac

Ketroloc tromethamine

Cryotherapy OTHER

final rinse with cold saline during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis

Also known as: Cold saline

Cryothrapy

Saline OTHER

final rinse with saline at room temperature during single visit endodontic treatment in mandibular molar teeth with symptomatic irreversible pulpits and apical periodontitis

Saline at room temperature

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Medically free patients
• Age between 18-40 years old
• Males or females
• Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II).
• Mandibular permanent molar teeth:
• Diagnosed clinically with symptomatic irreversible pulpitis associated with apical periodontitis.
• Presence of spontaneous pain and sharp pain to cold tester (ethyl-chloride) that lingers after removal of the stimulus compared to the contra-lateral tooth
• Tenderness to percussion with normal periapical radiographic appearance or slight widening of the lamina dura

You may not qualify if:

• \- Participants allergic to NSAIDS
• Pregnant females
• Participants having significant systemic disorder
• If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively.
• Participants with psychological disturbances
• Participants with bruxism or clenching
• Participants having acute pain in more than one mandibular molar
• Participants with mandibular molar teeth showing:
• Swelling or fistulous tract
• Acute or chronic periapical abscess
• Mobility greater than grade I
• Periodontitis
• Previous endodontic treatment or non-restorability

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo univresity

Giza, 11211, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac Tromethamine; Cryotherapy; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants didn't know to which group they are allocated and the outcome assessor received the data in an excel sheet
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BDS, MsC

Model Details: Participants presenting with symptomatic irreversible pulpits and apical periodontitis in their mandibular molars

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 2, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)