Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block

A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis

A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Dexamethasone Oral Tablet; Drug: Placebo

Detailed Description

Participants, Interventions and Outcome

Setting:

Patients are of the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.

• The dental Unit is Adec 200 U.S.A.
• The x-ray Machine is ViVi, S.r.I, Italy
• The x-ray films are Kodac, speed D, size 2.
• The operators are master degree students in the department of Endodontics.
• No dental assistant
• Time: 2017-2016

Procedure steps:

1. Patients are asked to rate the pain level on numerical rating scale before the administration of drug to get the baseline record for the pain preoperatively.
2. Thirty minutes before the endodontic procedure,dexamethasone (0.5 mg) or a placebo will be administered.Root canal therapy in all cases was completed in a single visit.
3. After explanation of the treatment procedures (according to individual needs), the tooth will be anesthetized by an inferior alveolar nerve block (1.8 ml mepivacaine hydrochloride 2% 1: 100,000 epinephrine) using a side loading aspirating syringe and 27-gauge long needle.
4. At 15-minutes post injection, access cavity will be performed using round bur size 4 and endo-z bur and the pain is recorded .
5. Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity.
6. Checking the patency of the canal with K- file size 10 taper 0.02, extirpation of pulp with H-file size 15 taper 0.02 with recording the pain.
7. Cleaning and shaping will be performed with a hybrid technique using hand K-files and rotary files for all teeth.
8. Irrigation will be performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation will made by saline.
9. After drying the canals with sterile paper points, they will be coated with AD-Seal sealer and obturated with gutta-percha using the lateral condensation technique.
10. The tooth will be then temporized by using cavit temporary filling and reduced from occlusion.
11. A rescue medication (ibuprofen) will be prescribed and the patients will be instructed to take it only if they experienced severe pain postoperatively. If rescue medication will be taken within the 48 hours after the treatment, then the patient will be excluded from the study.

Patients will be asked to make a mark on the point that represents level of perceived pain. (before the commencement of any treatment [baseline score]; at access and pulp extirpation, immediately after treatment completion; and 6, 12, 24, and 48 hours after the commencement of treatment). All subjects will be recalled after 2 days to return the pain diary and for a clinical evaluation.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Manyal
    • Cairo, Manyal, Egypt, 02
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars
3. Age range is between 20 and 50 years
4. Patients who can understand the categorical tool (points) for measurement
5. Patients able to sign informed consent

Exclusion Criteria:

1. Patients with positive percussion test
2. Patients having history of necrosis with or without apical pathosis
3. Patients have sinus tract or fistula extraoral or intraoral
4. Patients having active pain in more than one molar
5. Patients who had taken analgesics in the 12 hours preceding the preparation.
6. Complicating systemic disease
7. Subjects with allergies and hypersensitivity to or unable to take dexamethasone
8. Teeth with grade 2 or 3 mobility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug dexamethasone; preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.	Drug: Dexamethasone Oral Tablet; single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo
Placebo Comparator: Placebo; Placebo will be administrated to patients before stating of root canal treatment	Drug: Placebo; Placebo will be administrated 30 minutes before start of root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Numerical rating scale	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of inferior alveolar nerve block	Numerical rating scale	2 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Manar Hamouda, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 12, 2017
• Primary Completion (Anticipated): October 12, 2017
• Study Completion (Anticipated): July 7, 2018

Study Registration Dates

• First Submitted: June 18, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: kinda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes