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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Reversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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calcium silicate cement (Biodentine™)

calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.

Group Type EXPERIMENTAL

calcium silicate cement (Biodentine™)

Intervention Type DEVICE

calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.

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.

Group Type EXPERIMENTAL

Cone Beam computed tomography (Morita Accuitomo)

Intervention Type RADIATION

CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.

Periapical radiographs

Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.

Group Type ACTIVE_COMPARATOR

Periapical radiographs

Intervention Type RADIATION

Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.

Glass ionomer cement ( Fuji IX™)

Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.

Group Type ACTIVE_COMPARATOR

glass ionomer cement ( Fuji IX™)

Intervention Type DEVICE

glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.

Interventions

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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.

Intervention Type RADIATION

Periapical radiographs

Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.

Intervention Type RADIATION

calcium silicate cement (Biodentine™)

calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes