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

NCT07578662 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-11

No results posted yet for this 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 signs 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.

Conditions

  • Reversible Pulpitis
  • Extremely Deep Caries

Interventions

PROCEDURE

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.

PROCEDURE

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 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.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Dr. Pankaj Sangwan, MDS · PGIDS, Rohtak, 124001

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2027-04-28
Completion
2028-04-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578662 on ClinicalTrials.gov