Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
Recruiting · NCT07163975 · Interventional (participants receive a specific treatment) · Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
1 location listed.
- PGIDS Rohtak - Rohtak, Haryana, India