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Success of Complete Pulpotomy and Root Canal Treatment and Quality of Life in Patients With Symptomatic Irreversible Pulpitis With Type 2 Diabetes Mellitus: A Randomized Clinical Trial
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-09-09
106
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of type 2 diabetes mellitus (T2DM) on teeth with irreversible pulpitis, a painful dental condition. This study compares two dental treatments: complete pulpotomy and root canal therapy, in patients with T2DM. The aim is to understand which treatment has better success in managing irreversible pulpitis in mature permanent mandibular posterior teeth, as limited prior research has focused on diabetic patients with this condition. The study involves two treatment groups: one receiving complete pulpotomy and the other undergoing root canal treatment. Complete pulpotomy involves removing the exposed pulp tissue, controlling bleeding, and placing a biologically active material to promote healing, followed by restoration. Root canal treatment is performed in a single visit with cleaning, shaping, and filling of the root canals using standard dental instruments and irrigation. Both treatments are evaluated over a one-year period. Participants will be monitored through clinical and radiographic examinations at 3, 6, and 12 months to assess treatment success. Quality of life will also be assessed at 1 week, 6 months, and 12 months post-treatment. The study tracks healing, tooth vitality, and patient well-being related to dental health. The total study duration for each participant is one year, with close follow-up to evaluate outcomes and safety.
CONDITIONS
Brief 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 defined by HbA1c 6.5% - 8%, fasting plasma glucose 26;126 mg/dL, 2-hour plasma glucose 26;200 mg/dL during OGTT, or random plasma glucose 200 mg/dL with symptoms
- Age between 18 and 70 years
- Permanent mandibular posterior teeth with clinical and radiographic signs of irreversible pulpitis (PAI score 2)
- Tooth responds positively to pulp sensibility test and has no tenderness on percussion
- Body mass index (BMI) less than 30 kg/m2
You will not qualify if you...
- Patients with immunocompromised diseases or chronic kidney disease
- Smokers, pregnant or lactating women
- Teeth with immature roots or retained deciduous teeth
- Bleeding that cannot be controlled within 5 minutes
- Teeth with signs or symptoms of apical periodontitis
- Teeth with procedural errors, cracks, or fractures
- Teeth with probing depth greater than 4 mm
- Recent antibiotic use in past 1 month or requiring antibiotic prophylaxis, and analgesic use in past 3 days
- Patients taking drugs affecting bone metabolism such as immune-suppressants, SSRIs, bisphosphonates, or hormone replacement therapy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit for treatment
Participants receive either complete pulpotomy or root canal treatment for irreversible pulpitis in mandibular permanent posterior teeth.
1 treatment visit (in-person)
Duration - 12 months
Participants are monitored for clinical and radiographic success and quality of life after treatment.
Visits at 1 week, 3 months, 6 months, and 12 months post treatment
Trial Site Locations
Total: 1 location
1
PGIDS Rohtak
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
J
Jigyasa Duhan, MDS
A
Anmol Jain
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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