RCT of Pulp Capping Over Carious Exposure in Adults

University of Tromso (UiT)

Status: Completed

Conditions: Mature Teeth; Carious Exposure; Healthy Pulp; Proximal Caries; Reversible Pulpitis; Human Permanent First and Second Molars

Treatments: Procedure: Direct pulp capping; Procedure: Direct pulp capping with Dycal

Study type: Interventional

Funder types: Other

Identifiers

NCT01224925

UiT-IKO-MTA-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Capping over carious exposure with Dycal

Active Comparator group

Description:

Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)

Treatment:

Procedure: Direct pulp capping with Dycal

Capping over carious exposure with WMTA

Experimental group

Description:

Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA)

Treatment:

Procedure: Direct pulp capping