Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth

Study Overview
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Brief Summary
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Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With & Without topical Application Of Simvastatin

Detailed Description
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Objective: The objective of this study was to compare: 'The salivary BMP-2 levels in the experimental and the control groups with and without topical simvastatin application on wound of extracted tooth socket. The bone density at extracted tooth socket by measuring mean gray value from Intra oral periapical (IOPA) radiographs in the experimental and the control groups. Method: Twenty four patients either male or female without any systemic disease, aged between 18 years to 25 years were selected. The patients were equally divided by random computer generated numbers into experimental and control groups. In the experimental group, tooth extraction was followed by placement of simvastatin (containing 10 mg of drug). In the control group, only tooth extraction was done. Saliva sample was collected from patients on days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by measuring mean gray values with the help of ImageJ software. The data was entered in SPSS version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.

Official Title
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Salivary Bmp-2 Levels And Radiographic Measurement Of Bone Density At Extracted Tooth Socket In Patients With And Without Topical Application Of Simvastatin

Conditions
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Bone Injury

Intervention / Treatment
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* Drug: Simvastatin 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female patients with permanent dentition, age (18 years to 25 years) were considered. Patients undergoing extraction of maxillary or mandibular Pre molars for orthodontic procedure. Teeth which required only simple non surgical extraction only under local anesthesia. Exclusion Criteria: Subjects taking antibiotics or non-steroidal anti inflammatory drugs (NSAIDS) within one week. Patients with oral mucosal lesions (leukoplakia, erythroplakia, lichen planus). Patients with oral carcinoma. Patients with xerostomia. Previous history of radiotherapy or chemotherapy Patient with known hypersensitivity to anti inflammatory drugs. Diabetic patients. Pregnant and lactating patients. Patients with social habits such as cigarette smoking and alcohol consumption. Teeth radiographically involved in any abscess/cyst/granuloma. Teeth requiring open surgical transalveolar extraction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br>Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN). | |
| Experimental: Simvastatin<br>Atraumatic Extraction and administration of SIMVASTATIN (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket. | Drug: Simvastatin 10mg<br>* Atraumatic Extraction and administration of SIM (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket to observe alveolar bone healing.<br>* Other names: SIM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary BMP-2 Levels | Mean values were measured using ELISA technique | At start of study | 
| Salivary BMP-2 Levels | Mean values were measured using ELISA technique | At 3rd day Of Study | 
| Salivary BMP-2 Levels | Mean values were measured using ELISA technique | At 10th Day of study | 
| Salivary BMP-2 Levels | Mean values were measured using ELISA technique | At 40th Day of study | 
| Bone Density | Mean grey value were measured using imageJ software | At start of study | 
| Bone Density | Mean grey value were measured using imageJ software | At 40th day of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simvastatin, Salivary BMP-2, Radiographic Bone density