Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block

Early Phase 1

• Conditions: Postoperative Pain
• Interventions: Drug: Dexamethasone Oral Tablet; Drug: Placebo

• Registration Number: NCT03199482
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-23
• Last Update Submitted: 2017-06-23
• Study First Posted: 2017-06-27
• Last Update Posted: 2017-06-27
• Study Start: 2017-07-12
• Primary Completion: 2017-10-12
• Study Completion: 2018-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug dexamethasone	Dexamethasone Oral Tablet	preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.
Placebo	Placebo	Placebo will be administrated to patients before stating of root canal treatment

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours	Numerical rating scale

Secondary Outcome Measures

Name	Time	Method
success of inferior alveolar nerve block	2 hours	Numerical rating scale

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Manyal, Egypt