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Completed
NCT06586775
Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis
Conditions: Irreversible Pulpitis, Diabetes Mellitus, Type 2, Healthy
Sex: All
Ages: 35 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Location: Dr.keerthana Rohtak Haryana
Summary
Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Eligibility Criteria
Inclusion Criteria:
1. Type 2 diabetes mellitus with HbA1c \> 6.5% \> 7% with no other co-morbidities.
2. Age and gender matched healthy patients
3. Age between 35 - 70 years.
4. Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
5. Tooth showing positive response to pulp sensibility testing.
Exclusion Criteria:
1. Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
2. Smokers, pregnant and lactating women
3. Teeth with immature roots or retained deciduous tooth.
4. Bleeding could not be controlled in ≥8 minutes.
5. Tooth with signs and symptoms of apical periodontitis.
6. Tooth with probing depth more than 4mm.
7. Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
Source: ClinicalTrials.gov (NCT06586775). StuddyBuddy aggregates publicly available trial information.