Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth (salivaryBMP2)

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

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

Study Overview

• Status: Completed
• Conditions: Bone Injury
• Intervention / Treatment: Drug: Simvastatin 10mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Dental Department of Lahore General Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN).
Experimental: Simvastatin; 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; 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.; Other Names: SIM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Postgraduate Medical Institute, Lahore
• Investigators: Study Chair: shagufta nasreen, Pgmi. Lahore

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): October 3, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Simvastatin; Salivary BMP-2; Radiographic Bone density
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: M.Phil Oral Biology Trainee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No