RCT of Pulp Capping Over Carious Exposure in Adults

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Direct pulp capping with Dycal
* Procedure: Direct pulp capping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capping over carious exposure with Dycal<br>Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany) | Procedure: Direct pulp capping with Dycal<br>* 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<br>* Other names: (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany;|
| Experimental: Capping over carious exposure with WMTA<br>Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA) | Procedure: Direct pulp capping<br>* 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.<br>* Other names: WMTA - White Mineral Trioxide Aggregate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of Capped Pulps | 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. | 44 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain 1 Week After Treatment. | Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carious exposure, pulp capping, MTA, Dycal