NCT02201641

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Reversible Pulpitis

Interventions

Type	Name	Description
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.
RADIATION	Periapical radiographs	Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
DEVICE	calcium silicate cement (Biodentine™)	calcium silicate cement (Biodentine™) 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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2014-07-28
• Last updated: 2017-03-03

Locations

1 site across 1 country: United Kingdom