Actively Recruiting
Comparative Evaluation of Direct Pulp Capping and Complete Pulpotomy in Mature Permanent Mandibular Molars with Moderate Pulpitis Signs
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2024-06-07
92
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two dental procedures, direct pulp capping and complete pulpotomy, in adults with mature permanent lower molars showing signs of moderate pulpitis. Moderate pulpitis is characterized by prolonged sensitivity to cold lasting minutes, possible sensitivity to percussion, and spontaneous dull pain, which corresponds to irreversible pulp inflammation. The study aims to determine if the less invasive direct pulp capping has outcomes comparable to the complete pulpotomy, traditionally recommended for such cases, by assessing clinical and radiographic success and pain levels. Participants will receive one of two treatments after caries removal. In the direct pulp capping group, bleeding pulp tissue will be treated with sodium hypochlorite and capped with mineral trioxide aggregate (MTA), then sealed with resin-modified glass ionomer cement and composite resin restoration. In the complete pulpotomy group, the pulp tissue is removed to the canal orifices, followed by similar hemostasis and capping procedures with MTA and restoration. Cases where bleeding cannot be controlled within 6 minutes will be excluded and managed differently. Participants will be followed for 12 months to evaluate clinical and radiographic success of the treatments. Pain incidence and intensity will be monitored daily for one week after treatment. Assessments include pulp sensibility testing, periapical radiographs, and checking periodontal health. The study is randomized and double-blinded to compare outcomes fairly, with the overall goal of finding effective, minimally invasive options for managing moderate pulpitis.
CONDITIONS
Brief Title
COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Restorable mature permanent first or second mandibular molars with deep caries involving two-thirds or more of dentine
- Tooth must respond positively to pulp sensibility testing
- Clinical diagnosis of moderate pulpitis
- Radiographic periapical index (PAI) score of 2 or less
- Healthy periodontal status with pocket depths of 3 mm or less and normal tooth mobility
You will not qualify if you...
- Teeth with immature roots
- No pulp exposure after caries removal
- Bleeding that cannot be controlled within 6 minutes
- Signs of pulp death, sinus tract, swelling, or insufficient bleeding after pulp exposure
- Use of analgesics within the past week or antibiotics within the past month
- Internal or external root resorption
- Medical history including alcoholism, smoking, diabetes, hypertension, drug dependency, heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver problems, or migraine
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment visit
Participants receive either direct pulp capping or complete pulpotomy to treat moderate pulpitis in mature permanent mandibular molars.
1 visit (in-person)
Duration - 12 months with pain assessments daily for 7 days post-treatment
Participants are monitored for clinical and radiographic success, and pain incidence and severity are assessed post-operatively.
Pain assessments every 24 hours for 7 days; clinical and radiographic evaluations at 12 months
Trial Site Locations
Total: 1 location
1
PGIDS
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
V
Vinay Kumar, MDS
S
Sakshi Bansal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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