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

NCT07696702 | Recruiting

• 1 other identifier: Vineeta
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reversible Pulpitis; Deep Caries; Extremely Deep Caries

Keywords

Direct Pulp Capping; Deep caries; Extremely Deep caries; Reversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Postoperative pain

  Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (2)

Direct pulp capping in extremely deep carious lesion

EXPERIMENTAL

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 in deep carious lesion

ACTIVE COMPARATOR

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.

Interventions

Direct pulp capping in extremely deep carious lesion. PROCEDURE

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 extremely deep carious lesion

Direct pulp capping in deep carious lesion. PROCEDURE

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.

Direct pulp capping in deep carious lesion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient should be 18-40 years of age.
• Patients with deep and extremely deep caries in permanent mandibular molars.
• Deep caries lesion -Reaching the inner quarter of dentine on radiograph
• Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph.
• 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.
• Tooth should give positive response to pulp sensibility testing.
• Bleeding can be controlled with in 8 minutes.
• Radiographic finding of periapical index (PAI) score ≤2.
• Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).

You may not qualify if:

• Teeth with immature roots.
• Internal/external resorption.
• Patient experience spontaneous pain.
• Negative response to vitality testing
• No pulp exposure after complete caries excavation.
• Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
• Bleeding could not be controlled in 8 minutes.
• Pregnant women
• Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS , Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Dr. Vinay Kumar, MDS

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Vinay Kumar, MDS

CONTACT

8901149107; 29vinaykr@gmail.com

Dr. Vineeta Yadav, PG Student

CONTACT

08209485968; vineeta1799@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IN (1)