Actively Recruiting
Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2026-05-11
154
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the presence of proximal caries affects the success of direct pulp capping in permanent mandibular molars showing signs of reversible pulpitis. The study aims to compare clinical and radiographic outcomes between teeth with occlusal carious lesions and those with proximal carious lesions. This research also evaluates patients' oral health-related quality of life and postoperative pain following treatment. The study includes participants aged 15 to 40 years with mature permanent mandibular molars exhibiting extremely deep caries and reversible pulpitis symptoms. Participants will receive direct pulp capping treatment, where after pulp exposure, the pulp wound is cleaned with 3% sodium hypochlorite, and bleeding is controlled within 5 minutes. ProRoot MTA material is applied over the exposed pulp, followed by resin-modified glass ionomer cement and permanent composite resin restoration. Two groups are studied: one with proximal carious lesions and one with occlusal carious lesions. Postoperative periapical radiographs will be taken at 6 and 12 months to assess treatment success. Throughout the study, participants will be monitored clinically and radiographically at 7 days, 6 months, and 12 months after treatment. Pain and oral health-related quality of life will be assessed daily for one week post-treatment. The main outcome measured is the success rate of the treatment at 12 months. The study will also record the time taken to control bleeding during the procedure and monitor for any adverse events or failures. Total participant involvement spans at least 12 months, with regular follow-ups to evaluate treatment durability and patient experience.
CONDITIONS
Brief Title
Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mature permanent mandibular molars with extremely deep caries penetrating the entire thickness of dentine as seen on X-ray, showing signs of reversible pulpitis
- Discomfort triggered by cold or sweet that goes away within seconds, with no spontaneous pain or significant changes around the tooth root on X-ray
- Positive response to electric and cold tests confirming pulp vitality and presence of bleeding after caries removal
- Diagnosis based on American Association of Endodontists 2019 terminology
- Teeth with negative response to tooth tapping and firm gum health (pocket depth ≤3 mm, normal mobility)
- Hemostasis achieved within 5 minutes during treatment
- Pulp exposure size between 0.5 and 1 mm
You will not qualify if you...
- Pulp exposure caused by trauma
- No pulp exposure after removing decay
- Failure to stop bleeding within 5 minutes during treatment
- Irreversible pulpitis or periapical lesions
- Periodontal disease, resorptive defects, or calcified canals seen on X-rays
- Immunocompromised individuals, pregnant women, or those with systemic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive direct pulp capping on either proximal or occlusal carious lesions. This involves cleaning the pulp wound, controlling bleeding, applying a pulp capping material, and restoring the tooth permanently with composite resin.
1 treatment visit (in-person)
Duration - 12 months
Participants are monitored for clinical success and pain experience through postoperative assessments and radiographic evaluations.
1 visit at 7 days, daily pain assessments for 7 days post-treatment, and follow-up visits at 6 months and 12 months
Trial Site Locations
Total: 1 location
1
PGIDS Rohtak, Rohtak, Haryana 124001
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
D
Dr. Pankaj Sangwan, MDS
D
Dr. Aditi Diwan, PG student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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