Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irr… (NCT06586775) | Clinical Trial Compass
CompletedNot Applicable
Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis
India40 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Type 2 diabetes mellitus with HbA1c \> 6.5% with no other co-morbidities.
✓. Age and gender matched healthy patients
✓. Age between 18 - 70 years.
✓. Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
✓. Tooth showing positive response to pulp sensibility testing.
Exclusion criteria
✕. Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
✕. Smokers, pregnant and lactating women
✕. Teeth with immature roots or retained deciduous tooth.
✕. Bleeding could not be controlled in ≥8 minutes.
✕. Tooth with signs and symptoms of apical periodontitis.
What they're measuring
1
Treatment outcome
Timeframe: 6 and 12 month follow-up.
Trial details
NCT IDNCT06586775
SponsorPostgraduate Institute of Dental Sciences Rohtak