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

King's College London

Status and phase: Unknown; Phase 4

Conditions: Reversible Pulpitis

Treatments: Radiation: Cone Beam computed tomography (Morita Accuitomo); Device: calcium silicate cement (Biodentine™); Radiation: Periapical radiographs; Device: glass ionomer cement ( Fuji IX™)

Study type: Interventional

Funder types: Other

Identifiers

NCT02201641

11-LO-1893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 4 patient groups

calcium silicate cement (Biodentine™)

Experimental group

Description:

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

Treatment:

Device: calcium silicate cement (Biodentine™)

Cone Beam computed tomography (CBCT)

Experimental group

Description:

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

Treatment:

Radiation: Cone Beam computed tomography (Morita Accuitomo)

Periapical radiographs

Active Comparator group

Description:

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

Treatment:

Radiation: Periapical radiographs

Glass ionomer cement ( Fuji IX™)

Active Comparator group

Description:

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

Treatment:

Device: glass ionomer cement ( Fuji IX™)