Clinical trial Recruiting at 1 site Interventional Ages 18 to 40

Pulpal inflammation and full pulpotomy outcomes in deeply carious mandibular molars

Official title: "The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."

Run by Postgraduate Institute of Dental Sciences Rohtak · NCT07825415 · Data updated 2026-11-12

This study tests whether levels of inflammatory markers IL-1β and IL-6 in deeply decayed mandibular molars predict the success of a full pulpotomy in adults with moderate to severe pulpitis.

Quick facts

Study typeInterventional
Ages18 Years to 40 Years
SexAll
Enrollment86 (estimated)
SponsorPostgraduate Institute of Dental Sciences Rohtak
Academic / other
Locations1 site (Rohtak, Haryana)
StatusRecruiting
StartedApril 29, 2026
Main results expectedApril 28, 2027
Study endsApril 28, 2028
Registry record updatedSeptember 17, 2026
Trial IDNCT07825415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-40 with extremely deep caries in permanent mandibular molars, diagnosed as moderate or severe pulpitis, and ASA 1.

Probably not a fit

Patients not showing a relationship between inflammatory markers and outcomes or with different confounding factors may not experience a predictive benefit.

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

What this trial studies

This prospective cohort study investigates how pulpal inflammatory markers IL-1β and IL-6 relate to the outcome of full pulpotomy in mandibular molars with extremely deep caries. Participants are adults aged 18-40 with medically healthy status (ASA 1) and specific radiographic and clinical criteria indicating moderate to severe pulpitis. The intervention is full pulpotomy, and outcomes will be correlated with biomarker levels to see if inflammatory status helps predict treatment success. The study aims to clarify the biological underpinnings of pulpitis severity and improve decision-making for pulpotomy in deeply carious teeth.

Why it matters

Potential benefit: If successful, biomarker testing could help predict pulpotomy outcomes and guide treatment decisions for deeply carious teeth.

How similar studies have gone: Prior research has linked pulpal inflammation markers to local tissue responses, but this specific biomarker-outcome relationship in full pulpotomy is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* o Medically healthy patients (ASA 1).

  * Age 18-40 years
  * Patients with extremely deep caries in permanent mandibular molars.
  * Extremely deep caries, that is penetrating the entire thickness of the dentine without a radiopaque zone separating the lesion from the pulp
  * PAI score less then or equal to 2
  * Pulpal diagnosis via clinical and radiographic examination as well as thermal, electric pulp testing, categorized as moderate pulpitis (Heightened and prolonged reaction to cold, which can last for minutes Possible percussion sensitive Stimulated or spontaneous lingering pain that can be suppressed with analgesics. No sleep disturbance) or severe pulpitis (Severe spontaneous pain Clear lingering pain reaction to cold and warms stimuli Sleeping disturbance and lingering pain Possible sensitive to percussion Extremely deep caries mostly).

Exclusion Criteria:

* • Primary teeth

  * Traumatic or mechanical exposure
  * No pulp exposure after caries excavation.
  * Haemostasias not achieved within 10 minutes.
  * Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.
  * Patients with periodontal disease, swelling and sinus tract.
  * Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic and analgesic use within week before the treatment.

Where it's running

  • PGIDS, Rohtak
    Rohtak, Haryana, India
    Recruiting

Study contacts

  • Principal investigator: Dr. Akankshya Pattnaik — Postgraduate Institute of Dental sciences, Rohtak 124001
  • Study coordinator: Dr. Akankshya Pattnaik, PG student
  • Email: akankshyapattnaik44@gmail.com
  • Phone: 8658292111

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.