Irreversible Pulpitis Clinical Trial
Official title:
Comparative Evaluation of Success Rate of TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Cariously Exposed Mature Permanent Molars- A Randomized Clinical Study
Verified date | February 2023 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.
Status | Active, not recruiting |
Enrollment | 72 |
Est. completion date | May 30, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 14 Years |
Eligibility | Inclusion Criteria: 1. Patient should be between 9-14 years of age 2. Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain 3. Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries. 4. Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed 5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy 6. Diagnosis should be irreversible pulpitis. 7. The tooth is restorable and free from advanced periodontal disease 8. Soft tissues around the tooth are normal with no swelling or sinus tract 9. Haemostasis should be achieved after complete pulpotomy 10. The patient has non-contributory medical history Exclusion Criteria: 1. Teeth with immature roots 2. Non-restorable 3. Pathological mobility 4. Pus discharge through an associated sinus tract 5. Swelling of associated tissues 6. Radiographic internal or external resorption or with any periapical rarefaction 7. Necrotic pulp upon exposure. 8. Bleeding beyond 25 minutes 9. Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention. 10. Parents and patients unwilling for participation in the study. |
Country | Name | City | State |
---|---|---|---|
India | POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical success rate | Clinical success criteria :
No history of spontaneous pain or discomfort except for the first day after treatment No tenderness to palpation or percussion and the tooth is functional Normal mobility and probing pocket depth Soft tissues around the tooth are normal with no swelling or sinus tract |
Baseline to 12 months | |
Primary | Radiographic success rate | Radiographic success criteria:
No pathosis evident on the radiograph such as root resorption, new furcal or periapical pathosis No canal obliteration |
Baseline to 12 months | |
Secondary | Pain assessment | To assess the intensity and incidence of pain post-operatively at every 24 hr interval for 7 days using a Visual Analog Scale (VAS) having a score from 0-10. Score 0 means no pain and score 10 means maximum pain. | Baseline to 7 days | |
Secondary | Hemostasis duration | To evaluate the correlation between the timing of hemostasis achieved and the success rate of coronal pulpotomy | Baseline to 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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