NCT07163975Recruiting
Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. To date, no human clinical trial has examined the impact of diabetes mellitus on teeth with irreversible pulpitis. Due to the paucity of data in the literature, there is a clinical dilemma whether to recommend root canal therapy or vital pulp therapy in diabetic patients with irreversible pulpitis. To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy versus root canal treatment in T2DM patients with irreversible pulpitis. The aim of this study is to compare and evaluate the success rates of pulpotomy and root canal treatment in type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Diseases
- Type 2 diabetes
- NCT number
- NCT07163975
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 1 May 2025 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients taking drugs that affect bone metabolism such as immune- suppressants, SSRIs, bisphosphonates, hormone replacement therapy
Other illness
- Patients with immunocompromised diseases or chronic kidney disease
- Bleeding could not be controlled in ≥5 minutes.
- Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
Other
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Tooth with signs and symptoms of apical periodontitis.
- Teeth with procedural errors, cracks, fractured teeth
- Tooth with probing depth more than 4mm.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PGIDS Rohtak Coordinator of this site? Confirm its status | Rohtak | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.