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RCT of Pulp Capping Over Carious Exposure in Adults

Primary Purpose

Carious Exposure, Human Permanent First and Second Molars, Mature Teeth

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Direct pulp capping with Dycal
Direct pulp capping
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Exposure focused on measuring carious exposure, pulp capping, MTA, Dycal

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Avimeda Dental Clinic
  • Alta Dental Clinic
  • Sandessjoen Dental Clinic
  • Tromso University Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Capping over carious exposure with Dycal

Capping over carious exposure with WMTA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative Pain 1 Week After Treatment.
Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.

Full Information

First Posted
October 18, 2010
Last Updated
December 7, 2018
Sponsor
University of Tromso
Collaborators
Norwegian Public dental health service
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1. Study Identification

Unique Protocol Identification Number
NCT01224925
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 18, 2010 (Actual)
Primary Completion Date
December 10, 2015 (Actual)
Study Completion Date
December 10, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tromso
Collaborators
Norwegian Public dental health service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Exposure, Human Permanent First and Second Molars, Mature Teeth, Proximal Caries, Healthy Pulp, Reversible Pulpitis
Keywords
carious exposure, pulp capping, MTA, Dycal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Masking
Participant
Masking Description
Patient -blinded
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capping over carious exposure with Dycal
Arm Type
Active Comparator
Arm Description
Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)
Arm Title
Capping over carious exposure with WMTA
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Direct pulp capping with Dycal
Other Intervention Name(s)
(Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Direct pulp capping
Other Intervention Name(s)
WMTA - White Mineral Trioxide Aggregate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival of Capped Pulps
Description
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.
Time Frame
44 month
Secondary Outcome Measure Information:
Title
Postoperative Pain 1 Week After Treatment.
Description
Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Kundzina, DDS, PhD
Organizational Affiliation
University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avimeda Dental Clinic
City
Klaipeda
ZIP/Postal Code
91210
Country
Lithuania
Facility Name
Alta Dental Clinic
City
Alta
ZIP/Postal Code
9510
Country
Norway
Facility Name
Sandessjoen Dental Clinic
City
Sandnessjoen
ZIP/Postal Code
8800
Country
Norway
Facility Name
Tromso University Dental Clinic
City
Tromso
ZIP/Postal Code
9037
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
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RCT of Pulp Capping Over Carious Exposure in Adults

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