Reversible Pulpitis Clinical Trial
Official title:
Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.
Verified date | January 2018 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of the study was to evaluate and compare clinical and radiographic success with MTA and
calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.
Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of
Conservative Dentistry & Endodontics. Mature permanent mandibular molars with reversible
pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the
study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly
allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective
allocated material and then tooth in both groups were restored according to standard
protocol.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Patient willing to participate in the study. - Age group- 15-40 years. - Mature permanent mandibular molars with reversible pulpitis. - Teeth exhibiting occlusal pulp exposure from primary dental caries. Exclusion Criteria: - Primary teeth. - Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency. - Immuno-compromised, diabetic, pregnant and hypertensive patients. - Positive history of antibiotic and analgesic use within past one month of the treatment. - Failure to obtain authorization from patients. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials. | CRITERIA FOR SUCCESSFUL OUTCOME A positive vitality test. No pain on percussion. No widening of periodontal ligament on periapical radiograph. No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis. CRITERIA FOR FAILURE No response to pulp vitality test. Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis. |
Baseline to 1 year | |
Secondary | To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS). | Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure. Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm). Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose. |
Baseline to 7 days |
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