Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
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|ClinicalTrials.gov Identifier: NCT03199482|
Recruitment Status : Unknown
Verified June 2017 by Mai Mohamed Safei Eldin Sayed, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Dexamethasone Oral Tablet Drug: Placebo||Early Phase 1|
Participants, Interventions and Outcome
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||dexamethazone|
|Masking:||Double (Participant, Care Provider)|
|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|
|Estimated Study Start Date :||July 12, 2017|
|Estimated Primary Completion Date :||October 12, 2017|
|Estimated Study Completion Date :||July 7, 2018|
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
Placebo will be administrated 30 minutes before start of root canal treatment
- Postoperative pain [ Time Frame: 48 hours ]Numerical rating scale
- success of inferior alveolar nerve block [ Time Frame: 2 hours ]Numerical rating scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199482
|Contact: mai M sayed, bachelore||01012232932 ext email@example.com|
|Contact: amr M mansy, bachelore||01111663611 ext firstname.lastname@example.org|
|Faculty of Dentistry||Recruiting|
|Cairo, Manyal, Egypt, 02|
|Contact: mai mohamed safei eldin, bachelore 0102232932 ext 2012 email@example.com|
|Study Director:||Manar Hamouda, Professor||Cairo University|