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Completed

NCT Number: NCT01224925

RCT of Pulp Capping Over Carious Exposure in Adults

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avimeda Dental Clinic, Klaipėda, Lithuania

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About this study

Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth.

A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies.

Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct pulp capping with Dycal

Procedure

Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling

Other names: (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany

direct pulp capping

Procedure

WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.

Other names: WMTA - White Mineral Trioxide Aggregate

Primary outcomes

  1. Survival of Capped Pulps

    Time frame: 44 month

    Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.

Secondary outcomes

  1. Postoperative Pain 1 Week After Treatment.

    Time frame: one week

    Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • Norwegian Public dental health service

Registry information

Official study title

Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2010
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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