NCT06586775Completed
Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis
Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis - A Preliminary Prospective Interventional Study.
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Dec 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Diseases
- Type 2 diabetes
- NCT number
- NCT06586775
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Aug 2023 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
- Bleeding could not be controlled in ≥8 minutes.
- Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
Other
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Tooth with signs and symptoms of apical periodontitis.
- Tooth with probing depth more than 4mm.
Who the study is looking for
- Type 2 diabetes mellitus with HbA1c \> 6.5% \> 7% with no other co-morbidities.
- Age and gender matched healthy patients
- Age between 35 - 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.
Age in the registry: 35 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr.keerthana Coordinator of this site? Confirm its status | Rohtak | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.