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

NCT ID: NCT05928611

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-09-30

Brief Summary

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

Detailed Description

Aim :asseing the effect of intraligmentary dexamethasone on anesthetic efficacy of inferior alveolar nerve block and buccal infiltratation in lower first molar with irreversible pulpitis and apical periodontits, dexamethasone has antiinflammatory effect so it will improve the efficacy of anathesia and reduce postoperative by inhibition the production of phosopholipase and reduction of prostaglandins synthesis

Methods: diagnose the case clinically and readiographically Patients will divide into 3 groups First group will be given inferior alveolar nerve block 4%articaine Hcl1:100 epinephrine Second group will be given inferior alveolar nerve block 4%articaine with intraligmentary dexamethasone Third group will be given buccal infiltratation 4%articaine with intraligmentary dexamethasone After anathesia ,make access cavity and reduce the occulsa surface and make it out of occulsion .

Working length determination will be done by apex locator and confirm it by x ray .

Mechanical preparation will be done by FANTA files and apply EDTA on files Irrigate the canal by Naocl 2.5٪ Complete the root canal preparation through single visit. Obturate the canal by single cone technique and bioceramic sealer. During procedures , record pain intensity on HP visual scale Follow up the patient after 6,12,24 and 48 hours Describe Ibuprofen 200mg in case of sever pain Conclusion : it's predictable that the intraligmentary dexamethasone will reduce the pain during and after root canal procedures

Conditions

Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inferior alveolar nerve block

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

Group Type: ACTIVE_COMPARATOR

Inferior alveolar nerve block

Intervention Type: PROCEDURE

Using articaine for injection

Inferior alveolar nerve block with intraligmentary dexamethasone

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

Group Type: EXPERIMENTAL

Inferior alveolar nerve block with dexamethasone

Intervention Type: PROCEDURE

Using articaine for inferior alveolar block with intraligmentary dexamethasone

Buccal infiltratation with intraligmentary dexamethasone

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

Group Type: EXPERIMENTAL

Buccal infiltratation with dexamethasone

Intervention Type: PROCEDURE

Using articaine for buccal infiltratation with intraligmentary dexamethasone

Interventions

Inferior alveolar nerve block with dexamethasone

Using articaine for inferior alveolar block with intraligmentary dexamethasone

Intervention Type: PROCEDURE

Buccal infiltratation with dexamethasone

Using articaine for buccal infiltratation with intraligmentary dexamethasone

Intervention Type: PROCEDURE

Inferior alveolar nerve block

Using articaine for injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age between 20-45 years old.

2. Systemically healthy patient (ASA I or II).

3. 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).

Exclusion Criteria

1. Patients allergic to anesthetics, or dexamethasone (other corticosteroids).

2. Pregnant or nursing females.

3. Patients having significant systemic disorder (ASA III or IV).

4. Hemostatic disorders or anti-coagulant therapy during the last month.

5. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment.

6. Retreatment cases.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Wafaa Rezk Elshafaey

Prof.Dr. Angie Galal Ghoneim

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angie G Ghoneim

Role: STUDY_DIRECTOR

Faculty of oral and dental medicine,Cairo university

Central Contacts

Wafaa R Elshafaey

Role: CONTACT

wafaa.elshafaey@dentistry.cu.edu.eg

00201020773887

Mohamed M Abi Elhassan, Phd

Role: CONTACT

0020 111 167 7707

Other Identifiers

ENDO 3 - 3 - 5

Identifier Type: -

Identifier Source: org_study_id