Health Condition 1: K011- Impacted teeth Health Condition 2: K011- Impacted teeth
Conditions
Interventions
Intervention1: Sterile Semisolid Simvastatin Formulation: Anti-cholesterol drug simvastatin (10mg/ml) will be placed as semisolid carrier made up of oleic acid, PEG-400, TWEEN-80 along with simvastati
Sponsors
Dr Monika Gupta
Dr Asish Mathew Joseph
Eligibility
Inclusion criteria
Inclusion criteria: Surgical site should be free of infection. Patient requiring extraction bilaterally of impacted mandibular third molars. The site should be where primary wound closure can be achieved.
Exclusion criteria
Exclusion criteria: Patient having connective tissue/bleeding disorders. Patient who have undergone radiation/chemotherapy to head and neck region. Patients allergic to drug simvastatin. Patient having uncontrolled diseases of systemic nature. Patients with fibro-osseous diseases of bone. Any pathology associated with apical region of mandibular third molar. Patients on immuno-supressants and/or on anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bone height, bone volume, bone mineral density and trabecular pattern in the empty surgical extraction socket where simvastatin/PRF (Platelet Rich Fibrin) is placed, via CBCT analysis.Timepoint: CBCT analysis to be done- of bony socket before placement of Simvastatin/PRF immediately after surgical extraction of third molars (baseline). 6th month post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the probing depth distal to the second molar.Timepoint: 1st week, 3rd week, 3rd month and at 6th month.;To estimate pain at follow-up.Timepoint: 1st week, 3rd week, 3rd month and at 6th month.;To measure swelling at follow-up.Timepoint: 1st week, 3rd week, 3rd month and at 6th month.;To observe for trismus.Timepoint: 1st week, 3rd week, 3rd month and at 6th month. | — |
Countries
India
Contacts
Public ContactDr Tulshi Chakraborty
Maharishi Markandeshwar Deemed to be University
Outcome results
None listed