Actively Recruiting
Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-09-09
106
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (HbA1c 6.5%-8%, FPG ≥126 mg/dL, 2-hour plasma glucose ≥200 mg/dL during OGTT, or random plasma glucose ≥200 mg/dL with hyperglycemia symptoms)
- Age between 18 and 70 years
- Have permanent mandibular posterior teeth with clinical and radiographic signs of irreversible pulpitis (PAI score ≤2)
- Tooth shows positive response to pulp sensibility testing and no tenderness on percussion
- Body mass index (BMI) less than 30 Kg/m2
You will not qualify if you...
- Have immunocompromised diseases or chronic kidney disease
- Are smokers, pregnant, or lactating women
- Teeth with immature roots or retained deciduous teeth
- Bleeding that cannot be controlled within 5 minutes
- Tooth with signs or symptoms of apical periodontitis
- Teeth with procedural errors, cracks, or fractures
- Tooth with probing depth greater than 4 mm
- Recent antibiotic use within 1 month or analgesic use within past 3 days
- Taking drugs affecting bone metabolism such as immune-suppressants, SSRIs, bisphosphonates, or hormone replacement therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
PGIDS Rohtak
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
J
Jigyasa Duhan, MDS
CONTACT
A
Anmol Jain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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