Reversible Pulpitis Clinical Trial
Official title:
Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial
Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. Objectives: 1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Status | Not yet recruiting |
Enrollment | 106 |
Est. completion date | December 23, 2025 |
Est. primary completion date | December 23, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. The patient should be =18 years of age. 2. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score =2. 6. Healthy periodontium (probing pocket depth =3 mm and mobility within normal limit). 7. Pulp exposure after complete caries excavation. 8. No pulp exposure after incomplete caries excavation Exclusion Criteria: 1. Teeth with immature roots. 2. Pulp exposure after incomplete caries excavation. 3. No pulp exposure after complete caries excavation. 4. Bleeding could not be controlled in 5 minutes. 5. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure. 6. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month. 7. Internal/external resorption. 8. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine) |
Country | Name | City | State |
---|---|---|---|
India | PGIDS, Rohtak | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Success Rate | No history of spontaneous pain or discomfort except for the initial days after treatment.
No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. |
Base line to 12 months | |
Primary | Radiographic success | No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. | Base line to 12 months | |
Secondary | Pain incidence and reduction | Post operative pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to100 millimeter line. | Baseline to seven days |
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