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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05928611
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Anticipated Duration (Months): 15

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Irreversible Pulpitis	Procedure: Inferior alveolar nerve block with dexamethasone; Procedure: Buccal infiltratation with dexamethasone; Procedure: Inferior alveolar nerve block	N/A

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 4,6,12,24 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Intraligmentary Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block Versus Buccal Infiltratation in Lower First Molars With Irreversible Pulpitis and Apical Periodontits: A Randomized Clinical Trial
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inferior alveolar nerve block Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine	Procedure: Inferior alveolar nerve block; Using articaine for injection
Experimental: 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	Procedure: Inferior alveolar nerve block with dexamethasone; Using articaine for inferior alveolar block with intraligmentary dexamethasone
Experimental: 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	Procedure: Buccal infiltratation with dexamethasone; Using articaine for buccal infiltratation with intraligmentary dexamethasone

Outcome Measures

Primary Outcome Measures

1. Efficacy of local anesthesia [During procedure]

   Ask patient about pain intensity and record on Heft Parker visual analog scale scale and instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia

Secondary Outcome Measures

1. Post-operative pain [After procedure until 48hour]

   Patient will record the pain intensity on Heft Parker visual analog scale (4,6,12,24 &48h)

2. Number of needed analgesic tablets in case of intolerable pain [After procedure until 48hour]

   Ibuprofen 200mgm tabs have been described to patient in case of sever pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: Angie G Ghoneim, Faculty of oral and dental medicine,Cairo university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wafaa Rezk Elshafaey, Prof.Dr. Angie Galal Ghoneim, Cairo University
• ClinicalTrials.gov Identifier: NCT05928611
• Other Study ID Numbers: ENDO 3 - 3 - 5
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wafaa Rezk Elshafaey, Prof.Dr. Angie Galal Ghoneim, Cairo University: "Symptomatic irreversible pulpitis"/ "apical periodontitis"
• Additional relevant MeSH terms: Pulpitis; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Jul 3, 2023