Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age range is between 20 and 50 years
- Patients who can understand the categorical tool (points) for measurement
- Patients able to sign informed consent
Exclusion Criteria:
- Patients with positive percussion test
- Patients having history of necrosis with or without apical pathosis
- Patients have sinus tract or fistula extraoral or intraoral
- Patients having active pain in more than one molar
- Patients who had taken analgesics in the 12 hours preceding the preparation.
- Complicating systemic disease
- Subjects with allergies and hypersensitivity to or unable to take dexamethasone
- Teeth with grade 2 or 3 mobility
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Drug dexamethasone
Placebo
Arm Description
preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.
Placebo will be administrated to patients before stating of root canal treatment
Outcomes
Primary Outcome Measures
Postoperative pain
Numerical rating scale
Secondary Outcome Measures
success of inferior alveolar nerve block
Numerical rating scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03199482
Brief Title
Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
Official Title
A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2017 (Anticipated)
Primary Completion Date
October 12, 2017 (Anticipated)
Study Completion Date
July 7, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
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.
At 15-minutes post injection, access cavity will be performed using round bur size 4 and endo-z bur and the pain is recorded .
Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity.
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.
Cleaning and shaping will be performed with a hybrid technique using hand K-files and rotary files for all teeth.
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.
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.
The tooth will be then temporized by using cavit temporary filling and reduced from occlusion.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
dexamethazone
Masking
ParticipantCare Provider
Masking Description
investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug dexamethasone
Arm Type
Active Comparator
Arm Description
preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administrated to patients before stating of root canal treatment
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral Tablet
Intervention Description
single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administrated 30 minutes before start of root canal treatment
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Numerical rating scale
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
success of inferior alveolar nerve block
Description
Numerical rating scale
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
Patients having symptomatic irreversible pulpitis in one of their mandibular molars
Age range is between 20 and 50 years
Patients who can understand the categorical tool (points) for measurement
Patients able to sign informed consent
Exclusion Criteria:
Patients with positive percussion test
Patients having history of necrosis with or without apical pathosis
Patients have sinus tract or fistula extraoral or intraoral
Patients having active pain in more than one molar
Patients who had taken analgesics in the 12 hours preceding the preparation.
Complicating systemic disease
Subjects with allergies and hypersensitivity to or unable to take dexamethasone
Teeth with grade 2 or 3 mobility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mai M sayed, bachelore
Phone
01012232932
Ext
2012
Email
mai.safei247@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
amr M mansy, bachelore
Phone
01111663611
Ext
2012
Email
dr.amr.mansy.12@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manar Hamouda, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
State/Province
Manyal
ZIP/Postal Code
02
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mai mohamed safei eldin, bachelore
Phone
0102232932
Ext
2012
Email
mai.safei247@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
We'll reach out to this number within 24 hrs