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

Not Applicable

Not yet recruiting

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: Inferior alveolar nerve block; Procedure: Buccal infiltratation with dexamethasone; Procedure: Inferior alveolar nerve block with dexamethasone

• Registration Number: NCT05928611
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-23
• Status Verified: 2023-07
• Study First Posted: 2023-07-03
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Study Start: 2023-08
• Primary Completion: 2024-05
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inferior alveolar nerve block	Inferior alveolar nerve block	Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine
Buccal infiltratation with intraligmentary dexamethasone	Buccal infiltratation with 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
Inferior alveolar nerve block with intraligmentary dexamethasone	Inferior alveolar nerve block with 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

Primary Outcome Measures

Name	Time	Method
Intraoperative pain	During procedure	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

Secondary Outcome Measures

Name	Time	Method
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 (above6)
Post-operative pain	After procedure until 48hour	Patient will record the pain on numerical rating scale (6,12,24 \&48h)..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