Clinical trial Recruiting at 1 site Interventional Ages 15 to 40

Direct pulp capping in lower molars with side (proximal) versus top (occlusal) cavities: does the cavity location matter?

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

Run by Postgraduate Institute of Dental Sciences Rohtak · NCT07578662 · Data updated 2026-11-12

This research will test whether direct pulp capping works as well for lower molars with side (proximal) cavities as for those with top (occlusal) cavities in people aged 15–40 who have reversible pulpitis.

Quick facts

Study typeInterventional
Ages15 Years to 40 Years
SexAll
Enrollment154 (estimated)
SponsorPostgraduate Institute of Dental Sciences Rohtak
Academic / other
Locations1 site (Rohtak, Haryana)
StatusRecruiting
StartedApril 29, 2026
Main results expectedOctober 28, 2027
Study endsApril 28, 2028
Registry record updatedJune 10, 2026
Trial IDNCT07578662 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people aged 15–40 with mature permanent mandibular molars that have extremely deep caries, positive sensibility tests, bleeding on caries excavation, clinical signs of reversible pulpitis, and no significant periapical radiographic changes.

Probably not a fit

Patients with signs of irreversible pulpitis, necrotic pulp, significant periapical radiolucency, immature/root-development issues, or spontaneous persistent pain are unlikely to benefit from this procedure.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 15–40 with mature permanent mandibular molars, extremely deep caries and clinical signs of reversible pulpitis will receive direct pulp capping and be grouped by lesion location (proximal versus occlusal). Clinical outcomes will be recorded at 7 days, 6 months and 12 months, and radiographic outcomes will be assessed at 6 and 12 months. Oral health–related quality of life and postoperative pain will be measured at baseline and daily for one week after the procedure. The trial compares success rates and patient-reported outcomes between the two lesion-location groups to see if location affects the effectiveness of this conservative treatment.

Why it matters

Potential benefit: If successful, the results could support saving more deep-caries teeth with reversible pulpitis using a conservative direct pulp capping approach rather than more invasive treatment.

How similar studies have gone: Previous reports have shown high success rates for direct pulp capping—especially with materials like MTA—and some studies have found that factors such as patient age and site of exposure influence outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 -

Where it's running

  • PGIDS Rohtak, Rohtak, Haryana 124001
    Rohtak, Haryana, India
    Recruiting

Study contacts

  • Principal investigator: Dr. Pankaj Sangwan, MDS — PGIDS, Rohtak, 124001
  • Study coordinator: Dr. Pankaj Sangwan, MDS
  • Email: drps_1@yahoo.co.in
  • Phone: +919996112202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.