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N/A N=70 Randomized Single-blind Treatment

RCT of Pulp Capping Over Carious Exposure in Adults

Carious Exposure · Human Permanent First and Second Molars · Mature Teeth · Proximal Caries · Healthy Pulp

Bottom Line

View on ClinicalTrials.gov: NCT01224925 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Survival of Capped Pulps — 842; 1201 Survival days — p=<0.01

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Direct pulp capping with Dycal (Procedure); Direct pulp capping (Procedure)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Tromso
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Survival of Capped Pulps		 842; 1201 <0.01 sig
SECONDARY
Postoperative Pain 1 Week After Treatment.		 8; 10 >0.05

Summary

This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.

Eligibility Criteria

Inclusion criteria

  • Age 18-55 years
  • 1st and 2nd permanent molars
  • Proximal caries to inner 1/3 of dentin (bite-wing)
  • Apex closed, no periapical changes (apical radiograph)
  • No periodontal pockets deeper than 4mm
  • Medical history non-contributory (incl.pregnancy)
  • No medication (no antibiotics during last month)
  • No signs or symptoms more severe than reversible pulpitis
  • Positive response to electrical pulp test(EPT) or cold test
  • Written consent Inclusion requires compliance with all the criteria listed

Exclusion criteria

  • During the treatment there will be no pulpal exposure
  • The bleeding of the exposed pulp cannot be controled in 10 minutes
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01224925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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