Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial

March 1, 2017 updated by: King's College London
This study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called Biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called Fuji IX used more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes to the dental clinic when experiencing pain which commonly means the decay is deep and is very close to or has penetrated the nerve of the tooth. When the decay is very close to the pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the tooth and to prevent root canal treatment. A material has been introduced to the market for this purpose, called Biodentine. This study aims to investigate the nerve response to this material and to assess the quality of the overlying filling compared to another material (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to assess how close the decay is to the nerve and to see if there are abnormalities around the tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help improve diagnosis and care planning for patients.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • King's College Dental Institute at Guy's Hospital

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients either male or female over the age of 16 (who can consent for themselves) in good general health
  2. A minimum of one carious lesion (occlusal, proximal, or MOD)
  3. Positive pulp response to electric pulp test and thermal stimulation.

Exclusion Criteria:

  1. Patients with clinical symptoms of irreversible pulpitis who need root canal treatment
  2. The presence of fistulas or swelling
  3. Anterior teeth with aesthetic concerns
  4. External or internal root resorption
  5. Multiple teeth with carious lesions in the same quadrant,
  6. Mobile teeth or tenderness to percussion.
  7. Pregnant women, in view of requirements for radiographs.
  8. Patients younger than 16.
  9. Patients unable to give consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: calcium silicate cement (Biodentine™)
calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
Device: calcium silicate cement (Biodentine™)
calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
Experimental: Cone Beam computed tomography (CBCT)
CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
Radiation: Cone Beam computed tomography (Morita Accuitomo)
CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
Active Comparator: Periapical radiographs
Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
Radiation: Periapical radiographs
Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
Active Comparator: Glass ionomer cement ( Fuji IX™)
Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
Device: glass ionomer cement ( Fuji IX™)
glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
Time Frame: up to 2 years
The vitality of the restored tooth (whether the nerve of the tooth is alive or dead) is determined clinically by a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, absence of sinus/fistula/swelling and abnormal mobility, and absence/reduction of periapical radiolucencies as determined by PA radiographs.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The integrity of the composite restoration overlying the test or control material is either acceptable or not.
Time Frame: up to 2 years
As assessed clinically by USPHS criteria and Hickel's criteria for the assessment of dental restorations.
up to 2 years
The CBCT scans of the teeth restored with the test or control material are either more effective or are comparable to conventional radiographs in detecting the presence of early peri-radicular lesions associated with the restored teeth.
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

King's College London

Investigators

  • Study Chair: Timothy F Watson, BDS,MSc,PhD, King's College London

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

July 1, 2012

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-LO-1893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Reversible Pulpitis

Clinical Trials on calcium silicate cement (Biodentine™)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe