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Clinical Trials in India / NCT07696702
Recruiting Not applicable

Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .

NCT07696702 · tracked via the Priya Life Science India tracker
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Phase
Not applicable
Started
2026-04-29
Last updated
2026-07-28

Condition(s) studied

Reversible PulpitisDeep CariesExtremely Deep Caries

Investigational drug(s) / intervention(s)

Direct pulp capping in extremely deep carious lesion.Direct pulp capping in deep carious lesion.

Direct pulp capping in extremely 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.

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. 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: 1. The patient should be 18-40 years of age. 2. Patients with deep and extremely deep caries in permanent mandibular molars. 3. Deep caries lesion -Reaching the inner quarter of dentine on radiograph 4. Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph. 5. Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous. 6. Tooth should give positive response to pulp sensibility testing. 7. Bleeding can be controlled with in 8 minutes. 8. Radiographic finding of periapical index (PAI) score ≤2. 9. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit). Exclusion criteria 1. Teeth with immature roots. 2. Internal/external resorption. 3. Patient experience spontaneous pain. 4. Negative response to vitality testing 5. No pulp exposure after complete caries excavation. 6. Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling. 7. Bleeding could not be controlled in 8 minutes. 8. Pregnant women 9. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
PGIDS , Rohtak Rohtak Haryana Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07696702 on ClinicalTrials.gov ↗ ← All trials in India