NCT07163975 Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
| NCT ID | NCT07163975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jigyasa Duhan, MDS
PRINCIPAL INVESTIGATOR
PGIDS Rohtak
Frequently Asked Questions
Who can join the NCT07163975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07163975 currently recruiting?
Yes, NCT07163975 is actively recruiting participants. Contact the research team at prashitiduhan@rediffmail.com for enrollment information.
Where is the NCT07163975 trial being conducted?
This trial is being conducted at Rohtak, India.
Who is sponsoring the NCT07163975 clinical trial?
NCT07163975 is sponsored by Postgraduate Institute of Dental Sciences Rohtak. The principal investigator is Jigyasa Duhan, MDS at PGIDS Rohtak. The trial plans to enroll 106 participants.
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