Status:
RECRUITING
Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
Lead Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Irreversible Pulpitis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 reduc...
Detailed Description
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In extremely deep carious lesion with symptomatic irreversible pulpitis, vital pulp therapy procedures in t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT07163975
Start Date
May 1 2025
End Date
May 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
PGIDS Rohtak
Rohtak, Haryana, India, 124001