Reversible Pulpitis Clinical Trial
Official title:
Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
Verified date | February 2017 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 53 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Dental Institute at Guy's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The integrity of the composite restoration overlying the test or control material is either acceptable or not. | As assessed clinically by USPHS criteria and Hickel's criteria for the assessment of dental restorations. | up to 2 years | |
Secondary | 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 |
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