Clinical trial NCT02201641: Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
Official title: Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Reversible Pulpitis
Keywords: Indirect pulp capping
reversible pulpitis
periapical radiolucency
periapical radiographs
cone beam computed tomography
calcium silicate cements
glass ionomer cements
caries
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 53
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
timeFrame: up to 2 years
Secondary outcomes:
measure: The integrity of the composite restoration overlying the test or control material is either acceptable or not.
timeFrame: up to 2 years
measure: 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.
timeFrame: One year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Dental Institute at Guy's Hospital
Study officials:
affiliation: King's College London
name: Timothy F Watson, BDS,MSc,PhD
role: STUDY_CHAIR
References:
citation: Hashem D, Mannocci F, Patel S, Manoharan A, Watson TF, Banerjee A. Evaluation of the efficacy of calcium silicate vs. glass ionomer cement indirect pulp capping and restoration assessment criteria: a randomised controlled clinical trial-2-year results. Clin Oral Investig. 2019 Apr;23(4):1931-1939. doi: 10.1007/s00784-018-2638-0. Epub 2018 Sep 19.
citation: Hashem D, Mannocci F, Patel S, Manoharan A, Brown JE, Watson TF, Banerjee A. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial. J Dent Res. 2015 Apr;94(4):562-8. doi: 10.1177/0022034515571415. Epub 2015 Feb 20.