Health Condition 1: K040- Pulpitis Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Full Pulpotomy: Removal of a part of pulp inside the tooth and replacing it with a calcium silicate based cement.
The procedure is done in 45-60 minutes
Intervention2: Full Pulpotomy: R
Sponsors
Center for Dental Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Diabetic Patients:- 1.Patients with a history of T2DM having HbA1c levels >= 6.5% of either gender belonging to age range from 30 to 65 years. 2.Permanent mandibular first & second molars having carious lesion diagnosed clinically and radiologically as symptomatic irreversible pulpitis. 3.Teeth with positive response to electric pulp test and cold test. 4.Radiographic examination showing periapical index score (PAI) of 1 or 2. 5.Teeth with restorable carious lesions. 6.Periodontally sound teeth. 7.Absence of any signs of pulpal necrosis including swelling or sinus tract. Non Diabetic Patients:- 1.Patients having HbA1c levels years. 2.Permanent mandibular first & second molars having carious lesion diagnosed clinically and radiologically as symptomatic irreversible pulpitis. 3.Teeth with positive response to electric pulp test and cold test. 4.Radiographic examination showing periapical index score (PAI) of 1 or 2. 5.Teeth with restorable carious lesions. 6.Periodontally sound teeth. 7.Absence of any signs of pulpal necrosis including swelling or sinus tract.
Exclusion criteria
Exclusion criteria: Diabetic patientsâ?? exclusion criteria- 1.Radiographic examination showing periapical index score (PAI) of 3-5 2.Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health. 3.Patients with systemic conditions other than diabetes mellitus, like hypertension, bleeding disorders, asthma. and those required steroids. 4.Pregnant patients. 5.Patients having history of smoking 6.Patients with a history of antibiotic intake in the preceding month. 7.Teeth with immature roots. 8.Patients not willing to participate in the study. Nondiabetic patientsâ?? exclusion criteria- 1.Radiographic examination showing periapical index score (PAI) of 3-5 2.Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health 3.Patients with systemic conditions 4.Patients taking steroids. 5.Pregnant patients. 6.Patients having history of smoking. 7.Patients with a history of antibiotic intake in the preceding month. 8.Teeth with immature roots. 9.Patients not willing to participate in the study Intraoperative exclusion criteria: 1.No pulp exposure seen after complete caries excavation 2.Clinical diagnosis changes to pulpal necrosis 3.Bleeding that cannot be controlled within 5- 10 minutes with 2.5% NaOCl wet cotton pellet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to evaluate the clinical and radiographic outcome of full pulpotomy performed in permanent mature mandibular molars indicative of symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients (HbA1c less then 6.5%) and compare them.Timepoint: 6month and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1. To evaluate the time taken to achieve hemostasis during full pulpotomy performed in permanent mandibular molars with symptomatic irreversible pulpitis in Type 2 diabetes mellitus patients (HbA1c greater or equal then 6.5%) and non diabetic patients(HbA1c less then 6.5%) and compare them. 2. To evaluate the pulp sensibility test in Type 2 diabetes mellitus patients(HbA1c greater or equal then 6.5%) and non diabetic patients(HbA1c less then 6.5%) and compare them.Timepoint: During procedure, at 6 month and 12 month | — |
Countries
India
Contacts
Public ContactDr Amrita Chawla
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed