Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 3, 2017
February 1, 2017
5 years
July 23, 2014
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
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 Outcomes (2)
The integrity of the composite restoration overlying the test or control material is either acceptable or not.
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.
One year
Study Arms (4)
calcium silicate cement (Biodentine™)
EXPERIMENTALcalcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
Cone Beam computed tomography (CBCT)
EXPERIMENTALCBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
Periapical radiographs
ACTIVE COMPARATORPeriapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
Glass ionomer cement ( Fuji IX™)
ACTIVE COMPARATORGlass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
Interventions
CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.
Eligibility Criteria
You may qualify if:
- Patients either male or female over the age of 16 (who can consent for themselves) in good general health
- A minimum of one carious lesion (occlusal, proximal, or MOD)
- Positive pulp response to electric pulp test and thermal stimulation.
You may not qualify if:
- Patients with clinical symptoms of irreversible pulpitis who need root canal treatment
- The presence of fistulas or swelling
- Anterior teeth with aesthetic concerns
- External or internal root resorption
- Multiple teeth with carious lesions in the same quadrant,
- Mobile teeth or tenderness to percussion.
- Pregnant women, in view of requirements for radiographs.
- Patients younger than 16.
- Patients unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College Dental Institute at Guy's Hospital
London, London, SE1 9RT, United Kingdom
Related Publications (2)
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.
PMID: 30232625DERIVEDHashem 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.
PMID: 25710953DERIVED
Study Officials
- STUDY CHAIR
Timothy F Watson, BDS,MSc,PhD
King's College London
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
July 28, 2014
Study Start
July 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
March 3, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share