Complete pulpotomy versus root canal for irreversible pulpitis in adults with Type 2 diabetes
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT07163975 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rohtak, Haryana
- PGIDS Rohtak — Rohtak, Haryana, India (Recruiting)
Study contacts
- Principal investigator: Jigyasa Duhan, MDS — PGIDS Rohtak
- Study coordinator: Jigyasa Duhan, MDS
- Email: prashitiduhan@rediffmail.com
- Phone: +91 9896270449
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.