Direct pulp capping in lower molars with side (proximal) versus top (occlusal) cavities: does the cavity location matter?
Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT07578662 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 \- 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 this trial is running
Rohtak, Haryana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.