Ignite Creation Date:
2024-05-06 @ 7:41 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02574468
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2015-10-03
Brief Title:
Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract Aim The aim of this randomized clinical trial was to histologically investigate possible effects of dexamethasone application on pulp tissue healing during one step mineral trioxide aggregate MTA-direct pulp capping DPC and miniature pulpotomy MP in healthy human premolar teeth
Methodology Forty intact premolar teeth of 10 orthodontic patients scheduled for extraction were randomized for DPC n20 or MP n20 A high speed bur under copious water coolant was used for mechanical exposing of buccal pulp horn site Prior to sealing with white ProRoot MTA 10 out of twenty pulpal wounds of each group were randomly received dexamethasone Cavities were restored with glass ionomer Teeth vitality was evaluated in 7 21 42 and 60 day follow-ups Signs andor symptoms of irreversible pulpitis or pulp necrosis were considered as failure After 60 days the teeth were extracted and submitted for histological examination Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the data P005
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Methodology Forty intact premolar teeth of 10 orthodontic patients scheduled for extraction were randomized for DPC n20 or MP n20 A high speed bur under copious water coolant was used for mechanical exposing of buccal pulp horn site Prior to sealing with white ProRoot MTA 10 out of twenty pulpal wounds of each group were randomly received dexamethasone Cavities were restored with glass ionomer Teeth vitality was evaluated in 7 21 42 and 60 day follow-ups Signs andor symptoms of irreversible pulpitis or pulp necrosis were considered as failure After 60 days the teeth were extracted and submitted for histological examination Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the data P005
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Detailed Description:
Clinical procedures All clinical procedures took place at private office of first author JG Using simple randomization procedures computerized random numbers forty intact premolars were randomly assigned to 1 of 4 treatment groups n10 I DPC II MP III DPCdexamethasone and IV MPdexamethasone After administration of local anesthesia 3 mepivacaine plain Septodont cedax France dental rubber dam was applied and tooth surface disinfected with 2 chlorhexidine gluconate Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed approximately 12 mm in diameter using a sterile high speed carbide round bur In MP depth of penetration to the pulp was 05 mm All of the cavity preparation procedures were intermittently performed under copious water coolant and light hand pressure Using a sterile 525 NaOCl-soaked cotton pellet bleeding from the exposure site was controlled and 2ml of sterile saline rinsed off NaOCl residues For blinding the practitioner to the materials dexamethasone Drabidi Tehran Iran and placebo were held in identical light proof syringes and numbered for each tooth according to the randomization schedule Each tooth was assigned an order number and its pulpal wound received the solution in the corresponding prepacked syringe prior to sealing off the exposure site with white ProRoot MTA Dentsply Tulsa OK MTA was mixed according to the manufacturers directions and a wet cotton pellet was placed over the material for 10 minutes Eventually the coronal cavity was restored with light cure resin modified glass ionomer Fuji II LC GC Corporation Tokyo Japan and cured for 40 seconds using a curing light All clinical procedures were performed by the same practitioner JG All patients took 400 mg of ibuprofen as a single dose for postoperative pain control Pulp and periapical status were clinically 7 21 42 and 60 days and radiographically evaluated 42 and 60 days during the study Clinical and radiographic signs andor symptoms of irreversible pulpitis or pulp necrosis were considered as treatment failure On the 60th day teeth were extracted atraumatically and prepared for submission to the oral pathology department for processing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None