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

Pulpitis - Irreversible Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05928611
• Other study ID #: ENDO 3 - 3 - 5
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Wafaa R Elshafaey
• Phone: 00201020773887
• Email: wafaa.elshafaey[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Inferior alveolar nerve block with dexamethasone
Using articaine for inferior alveolar block with intraligmentary dexamethasone
• Buccal infiltratation with dexamethasone
Using articaine for buccal infiltratation with intraligmentary dexamethasone
• Inferior alveolar nerve block
Using articaine for injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative pain	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	After procedure until 48hour
Secondary	Number of needed analgesic tablets in case of intolerable pain	Ibuprofen 200mgm tabs have been described to patient in case of sever pain (above6)	After procedure until 48hour