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Clinical Trials in India / NCT07578662
Recruiting Not applicable

Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis

NCT07578662 · tracked via the Priya Life Science India tracker
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Phase
Not applicable
Started
2026-04-29
Last updated
2026-06-10

Condition(s) studied

Reversible PulpitisExtremely Deep Caries

Investigational drug(s) / intervention(s)

Direct pulp capping in proximal carious lesionDirect pulp capping in occlusal carious lesion

Direct pulp capping in proximal carious lesion: After pulp exposure, pulp wound will be irrgated 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 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer ofRMGIC. 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 occlusal carious lesion: After pulp exposure, pulp wound will be irrgated 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 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. 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 assess the Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with sign of reversible pulpitis. objective- Primary objective- To evaluate and compare the clinical and radiographic outcome of Direct pulp capping in mandibular molars with occlusal and proximal carious lesions. Secondary objective- To evaluate and compare 1.OHRQoL after Direct pulp capping in occlusal and proximal lesion. 2. Postoperative pain, after Direct pulp capping in occlusal and proximal lesion Subjects of age group 15 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with proximal carious lesion 2)Permanent mature molars with occlusal carious lesion.

Eligibility

Sex
ALL
Min age
15 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: 1. Mature permanent mandibular molars with extremely deep caries that penetrate the entire thickness of dentine as detected on radiograph with reversible pulpitis will be included. 2. Participant with 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 the removal of the stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and the pain experienced is not spontaneous. 3. The pulpal sensibility will be confirmed through positive response to electric and cold tests (Endo frost) and the presence of bleeding after caries excavation. 4.Pulpal and the periapical diagnosis will be established based on the diagnostic terminology approved by American Association of Endodontists (AAE, 2019). 5.Teeth with a negative response to palpation and percussion testing and radiographic finding of periapical index (PAI) score ≤2 and healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) will be included. 6.Teeth in which hemostasis achieved within 5 mins will be included. 7.Only pulp exposures with size 0.5-1 mm will be included \- Exclusion Criteria: 1. Mechanical or pulp exposure due to trauma 2. absence of exposure after excavation of caries 3. failure to achieve hemostasis within 5 mins 4. irreversible pulpitis and teeth having periapical lesions 5. periodontal disease, resorptive defects, calcified canals, as assessed by radiographic examination will serve as criteria for exclusion. 6. Also immunocompromised, Pregnant and subjects having systemic diseases will be excluded -

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
PGIDS Rohtak, Rohtak, Haryana 124001 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 NCT07578662 on ClinicalTrials.gov ↗ ← All trials in India