Intraligmentary Dexamethasone in Lower First Molars With Irreversible Pulpitis and Apical Periodontits

NCT05928611 | Unknown DMC

• 1 other identifier: ENDO 3 - 3 - 5
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

Using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation

Conditions

Pulpitis - Irreversible

Keywords

" irreversible pulpitis with apical periodontitis"

Outcome Measures

Primary Outcomes (1)

• Intraoperative pain

  Efficacy of buccal infiltration anesthesia and inferior alveolar nerve block measured during procedures of root canal treatment using numerical rating scale.It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10= severe pain, "10" being the most intense pain conceivable.And instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia

  During procedure

Secondary Outcomes (2)

• Post-operative pain

  After procedure until 48hour

• Number of needed analgesic tablets in case of intolerable pain

  After procedure until 48hour

Study Arms (3)

Inferior alveolar nerve block

ACTIVE COMPARATOR

Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine

Procedure: Inferior alveolar nerve block

Inferior alveolar nerve block with intraligmentary dexamethasone

EXPERIMENTAL

Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for inferior alveolar nerve block and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection

Procedure: Inferior alveolar nerve block with dexamethasone

Buccal infiltratation with intraligmentary dexamethasone

EXPERIMENTAL

Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for buccal infiltratation and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection

Procedure: Buccal infiltratation with dexamethasone

Interventions

Inferior alveolar nerve block with dexamethasone PROCEDURE

Using articaine for inferior alveolar block with intraligmentary dexamethasone

Inferior alveolar nerve block with intraligmentary dexamethasone

Buccal infiltratation with dexamethasone PROCEDURE

Using articaine for buccal infiltratation with intraligmentary dexamethasone

Buccal infiltratation with intraligmentary dexamethasone

Inferior alveolar nerve block PROCEDURE

Using articaine for injection

Inferior alveolar nerve block

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20-45 years old.
• Systemically healthy patient (ASA I or II).
• Lower first molar with:
• Preoperative sharp pain.
• Slight widening in the periodontal ligament (PDL).
• Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

You may not qualify if:

• Patients allergic to anesthetics, or dexamethasone (other corticosteroids).
• Pregnant or nursing females.
• Patients having significant systemic disorder (ASA III or IV).
• Hemostatic disorders or anti-coagulant therapy during the last month.
• Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment.
• Retreatment cases.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Angie G Ghoneim

  Faculty of oral and dental medicine,Cairo university

  STUDY DIRECTOR

Central Study Contacts

Wafaa R Elshafaey

CONTACT

00201020773887; wafaa.elshafaey@dentistry.cu.edu.eg

Mohamed M Abi Elhassan, Phd

CONTACT

0020 111 167 7707

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. Angie Galal Ghoneim

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share