Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp

NCT02574468 | Completed Phase 4

• 1 other identifier: 91_509
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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 (n=20) or MP (n=20). 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 and/or 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 (P=0.05). HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda

Conditions

Vital Pulp Therapy

Keywords

Dexamethasone; Direct pulp capping; MTA; pulpotomy

Outcome Measures

Primary Outcomes (3)

• Histologic Evaluation of pulp for inflammation

  measure number of inflammatory cells for amount of inflammation

  one year

• Histologic Evaluation of pulp for calcified bridge

  measure thickness of calcified bridge on the pulp

  one year

• Histologic Evaluation of pulp for odontoblast layer

  measure odontoblastic cells on odontoblast layer

  one year

Study Arms (2)

DPC+Dexa

ACTIVE COMPARATOR

forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, 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 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm

Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp; Procedure: DPC or MP

MP+Dexa

ACTIVE COMPARATOR

forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, 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 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm

Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp; Procedure: DPC or MP

Interventions

Dexamethasone applied on pulp or Dexamethasone did not applied on pulp DRUG

on half of cases we put dexamethasone on pulp on other half we did not put dexamethasone on pulp

DPC+Dexa; MP+Dexa

DPC or MP PROCEDURE

on half of cases we treat teeth with DPC(Direct Pulp Cap) on other half we treat teeth with MP(Miniature Pulpotomy)

DPC+Dexa; MP+Dexa

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adult patients who had four intact fully developed upper and lower premolars needed to be extracted because of his/her orthodontic treatment plan were eligible

You may not qualify if:

• clinical and/or radiographic caries
• restorations, periodontal problems
• intake of anti-inflammatory medication before (over the last couple of weeks) and during the study
• known allergy and/or contraindications to dexamethasone

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead
• Mashhad University of Medical Sciences: collaborator

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of endodontics

Study Record Dates

• First Submitted: October 3, 2015
• First Posted: October 14, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 14, 2015

Record last verified: 2015-10