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

NCT07578662 | Recruiting

• 1 other identifier: Aditi Diwan
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

direct pulp capping

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 (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.

  12 months

Secondary Outcomes (2)

• 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

• OHRQoL assessment

  Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (2)

Direct pulp capping in proximal carious lesion

EXPERIMENTAL

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 proximal carious lesion

Direct pulp capping in occlusal 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 occlusal carious lesion

Interventions

Direct pulp capping in proximal carious lesion PROCEDURE

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 proximal carious lesion

Direct pulp capping in occlusal carious lesion PROCEDURE

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

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).
• 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.
• Only pulp exposures with size 0.5-1 mm will be included

You may not qualify if:

• Mechanical or pulp exposure due to trauma
• absence of exposure after excavation of caries
• failure to achieve hemostasis within 5 mins
• irreversible pulpitis and teeth having periapical lesions
• Also immunocompromised, Pregnant and subjects having systemic diseases will be excluded -

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS Rohtak, Rohtak, Haryana 124001

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Dr. Pankaj Sangwan, MDS

  PGIDS, Rohtak, 124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Pankaj Sangwan, MDS

CONTACT

+919996112202; drps_1@yahoo.co.in

Dr. Aditi Diwan, PG student

CONTACT

+918968227626; aditidiwan0@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: May 5, 2026
• First Posted: May 11, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

IN (1)