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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reversible Pulpitis; Extremely Deep Caries
• Intervention / Treatment: Procedure: Direct pulp capping in proximal carious lesion; Procedure: Direct pulp capping in occlusal carious lesion

Detailed Description

Title- Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with reversible pulpitis PICO P (Population) - Mature permanent mandibular molars with extremely deep caries and signs of reversible pulpitis.I (Intervention) - Direct Pulp Capping in Proximal carious lesion. C (Comparison) - Direct Pulp Capping in Occlusal carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up.

2. Assessment of OHRQoL pain experience at baseline, postoperatively every 24 hours for 1 week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to AAE, DPC should be performed only in mechanically exposed pulp. According to the position statement of European society of endodontology, however, if the teeth is vital and there is no sign of irreversible pulpitis, but has an extremely deep carious lesion with unavoidable pulp exposure, DPC can be the treatment of choice.According to bogen et al, DPC shows excellent success rate of 97.96% with MTA as capping agent material. In 2013, Cho et al, evaluated the outcome of direct pulp capping in cariously exposed pulp and the prognostic factors affecting the outcome. They found age and site of exposure to have a significant effect on the outcome of DPC.Site of exposure has always been the controversial topic, some studies show it has significant effect, some shows non- significant effect on outcome of DPC. As compare to occlusal lesion, in proximal lesion complete caries removal, application of pulp capping material and sealing of the cavity is difficult. Also, isolation is the key problem in proximal area which is difficult to obtain. All these factors have been suggested to make the outcome of proximal exposure more unfavorable than occlusal exposure with respect to prognosis of pulp capping. According to Cho et al, site of exposure shows significant effect on DPC and there is better survival rate on occlusal site [OR = 1] as compared to axial site [OR =3.9(1.3-15.8)]. Various studies have statistically assessed the site of exposure as secondary demographic variable affecting the outcome of DPC, there is no study till now which has directly, systematically compared the influence of occlusal and proximal lesion on the direct pulp capping.

Thus, the aim of the present study is to assess the influence of the proximal lesion on the outcome of direct pulp capping based on clinical and radiographical findings.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Pankaj Sangwan, MDS; Phone Number: +919996112202; Email: drps_1@yahoo.co.in
• Study Contact Backup: Name: Dr. Aditi Diwan, PG Student; Phone Number: +918968227626; Email: aditidiwan0@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS Rohtak, Rohtak, Haryana 124001
      • Contact: Dr. Pankaj Sangwan, MDS; Phone Number: +919996112202; Email: drps_1@yahoo.co.in
      • Contact: Dr. Aditi Diwan, PG Student; Phone Number: +918968227626; Email: aditidiwan0@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

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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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct pulp capping in proximal carious lesion; 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; 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.
Active Comparator: Direct pulp capping in occlusal carious lesion; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum 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	OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL	Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr. Pankaj Sangwan, MDS, PGIDS, Rohtak, 124001

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): April 28, 2028

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: direct pulp capping
• Other Study ID Numbers: Aditi Diwan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No