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Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Complete pulpotomy versus root canal for irreversible pulpitis in adults with Type 2 diabetes

Official title: Success of Complete Pulpotomy and Root Canal Treatment and Quality of Life in Patients With Symptomatic Irreversible Pulpitis With Type 2 Diabetes Mellitus: A Randomized Clinical Trial

Run by Postgraduate Institute of Dental Sciences Rohtak · NCT07163975 · Data updated 2026-11-12

This will test whether complete pulpotomy or root canal treatment better preserves symptom-free, functional mature back teeth with irreversible pulpitis in adults who have Type 2 diabetes.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment106 (estimated)
SponsorPostgraduate Institute of Dental Sciences Rohtak
Academic / other
Locations1 site (Rohtak, Haryana)
StatusRecruiting
StartedMay 1, 2025
Main results expectedMay 1, 2026
Study endsMay 1, 2027
Registry record updatedSeptember 9, 2025
Trial IDNCT07163975 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 with Type 2 diabetes (HbA1c 6.5–8% or equivalent glucose criteria), BMI <30, and a mature mandibular posterior tooth showing clinical signs of irreversible pulpitis with PAI ≤2 and positive pulp sensibility are ideal candidates.

Probably not a fit

Patients with poor glycemic control (outside the defined range), apical periodontitis, immunocompromising illness or chronic kidney disease, smokers, pregnant or lactating women, immature or cracked/fractured teeth, or probing depth >4 mm are unlikely to benefit from the pulpotomy option in this protocol.

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

What this trial studies

This prospective interventional comparison will enroll adults with Type 2 diabetes and mature mandibular posterior teeth presenting with clinical signs of irreversible pulpitis and PAI ≤2 to receive either complete pulpotomy or conventional root canal treatment. Eligible participants (age 18–70, BMI <30, defined T2DM by HbA1c or glucose criteria) will be treated at the enrolling center and followed with scheduled clinical and radiographic exams. Primary outcomes include clinical resolution of symptoms and radiographic healing or stability; secondary outcomes include need for further endodontic therapy and pulp sensibility where applicable. Patients meeting exclusion criteria such as apical periodontitis, immunocompromise, recent antibiotics, smoking, pregnancy/lactation, immature roots, or uncontrolled bleeding will not be enrolled.

Why it matters

Potential benefit: If successful, diabetics with irreversible pulpitis might be offered a less invasive, pulp-preserving option that can save teeth while avoiding full root canal therapy.

How similar studies have gone: Pulpotomy and other vital pulp therapies have shown promising outcomes in non-diabetic permanent teeth, but no prior prospective human trial has specifically compared pulpotomy versus root canal treatment in patients with Type 2 diabetes.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Type 2 diabetes mellitus defined by HbA1c levels 6.5% - 8% OR FPG ≥126 mg/dL OR 2-hour plasma glucose ≥200 mg/dL during an OGTT OR A random plasma glucose of 200 mg/dL or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
* Age between 18 - 70 years.
* Permanent mandibular posterior teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
* Tooth showing positive response to pulp sensibility testing with no tenderness on percussion.
* BMI\<30 Kg/m2

Exclusion Criteria:

* Patients with immunocompromised diseases or chronic kidney disease
* Smokers, pregnant and lactating women
* Teeth with immature roots or retained deciduous tooth.
* Bleeding could not be controlled in ≥5 minutes.
* Tooth with signs and symptoms of apical periodontitis.
* Teeth with procedural errors, cracks, fractured teeth
* Tooth with probing depth more than 4mm.
* Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
* Patients taking drugs that affect bone metabolism such as immune- suppressants, SSRIs, bisphosphonates, hormone replacement therapy

Where it's running

  • PGIDS Rohtak
    Rohtak, Haryana, India     Recruiting

Study contacts

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.
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Type 2 Diabetes Mellitus (T2DM) 68Irreversible Pulpitis 7Postgraduate Institute of Dental Sciences Rohtak 23
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.