Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials

July 23, 2018 updated by: Aliye Tugce Gurcan, Altinbas University

Evaluation of Indirect Pulp Capping in Children With Different Materials

Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials have been used for this procedure. The aim of this study is to evaluate the radiographic and clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and calcium hydroxide [Ca(OH)2] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 295 teeth, including second primary molars and first permanent molars with IPC indications from healthy and cooperative children between the ages of 4-15, were included in this study. Teeth were divided into three groups according to the materials used for pulp capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89 teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material, and permanent molars were restored with the resin composite material. Restorations were evaluated with the Modified United States Public Health Service (modified USPHS) criteria. Clinical and radiographic findings were evaluated for 24 months at follow-up.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • teeth with clinical and radiographical indications of indirect pulp capping
  • systemically healthy and cooperative children

Exclusion Criteria:

  • teeth with contraindications of indirect pulp capping: Clinical Exclusion Criteria
  • Pain (spontaneous and chronic)
  • Fistula
  • Acute pulpal inflammation
  • Pain with percussion
  • Pathologic mobility
  • Abscess
  • Devitality symptoms (negative response to thermal pulp test) Radiographic Exclusion Criteria
  • Progression of caries lesion to pulp
  • Perforation of pulp
  • Intermittent or irregular lamina dura
  • Expanded range of periodontal ligament
  • Periapical radiolucency
  • Internal and external resorption
  • systemically unhealthy and uncooperative children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium Hydroxide (Dycal)
Indirect pulp capping treatment with Calcium Hydroxide
Drug: Calcium Hydroxide
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.
Other Names:
  • Dycal
  • Pulp capping agent
Drug: Mineral Trioxide Aggregate
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.
Other Names:
  • (ProRoot MTA)
Drug: TheraCal LC
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.
Other Names:
  • resin-based calcium silicate cement
Experimental: Mineral Trioxide Aggregate (ProRoot MTA)
Indirect pulp capping treatment with Mineral Trioxide Aggregate
Drug: Calcium Hydroxide
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.
Other Names:
  • Dycal
  • Pulp capping agent
Drug: Mineral Trioxide Aggregate
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.
Other Names:
  • (ProRoot MTA)
Drug: TheraCal LC
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.
Other Names:
  • resin-based calcium silicate cement
Experimental: Theracal LC
Indirect pulp capping treatment with Theracal LC
Drug: Calcium Hydroxide
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.
Other Names:
  • Dycal
  • Pulp capping agent
Drug: Mineral Trioxide Aggregate
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.
Other Names:
  • (ProRoot MTA)
Drug: TheraCal LC
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.
Other Names:
  • resin-based calcium silicate cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rates of the indirect pulp capping biomaterials
Time Frame: 24 months
No pathological symptom like abscess, fistulas or pain at percussion
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rates according to Modified USPHS criterias
Time Frame: 24 months
No failed restorations during the controls
24 months
Radiographical success rates of the indirect pulp capping biomaterials
Time Frame: 24 months
No radiolucency or root resorption, healing with dentin bridge
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altinbas University

Collaborators

Istanbul University

Investigators

  • Principal Investigator: Aliye Tuğçe Gürcan, Assist.Prof., Altinbas University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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