Clinical trial NCT01224925: RCT of Pulp Capping Over Carious Exposure in Adults
Official title: Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carious Exposure
Human Permanent First and Second Molars
Mature Teeth
Proximal Caries
Healthy Pulp
Reversible Pulpitis
Keywords: carious exposure
pulp capping
MTA
Dycal
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Norwegian Public dental health service
First posted: 2010-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Survival of Capped Pulps
timeFrame: 44 month
Secondary outcomes:
measure: Postoperative Pain 1 Week After Treatment.
timeFrame: one week
Other outcomes:
Locations:
city: Klaipeda
country: Lithuania
facility: Avimeda Dental Clinic
city: Alta
country: Norway
facility: Alta Dental Clinic
city: Sandnessjoen
country: Norway
facility: Sandessjoen Dental Clinic
city: Tromso
country: Norway
facility: Tromso University Dental Clinic
Study officials:
affiliation: University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
name: Rita Kundzina, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
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