An interventional study of Direct pulp capping in extremely deep carious lesion. and Direct pulp capping in deep carious lesion. in Reversible Pulpitis, Deep Caries and Extremely Deep Caries, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
The aim of the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.
TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis. I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion. C (Comparison) - Direct pulp capping in teeth with deep carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up. To assess pain experience at preoperative and post operatively at 24 hours intervals for one week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness). Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% to 100%. A prospective study by demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals. A randomized clinical trial , which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%. A recent systematic review and meta-analysis highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps. Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis. Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.
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Exclusion criteria
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis . If the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
Procedure: Direct pulp capping in extremely deep carious lesion.
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
Procedure: Direct pulp capping in deep carious lesion.
After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till. Hemostasis will be achieved with 3% NaOCl .The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes. Hemostasis will be achieved with 3% NaOCl . The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
Success rate at 12 months
Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (Periapical index score 1 or 2 ). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
Time frame: 12 months
Postoperative pain
Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain.
Time frame: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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