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

Phase 4

Completed

• Conditions: Bone Injury
• Interventions: Drug: Simvastatin 10mg

• Registration Number: NCT05369091
• Lead Sponsor: Postgraduate Medical Institute, Lahore

Brief Summary

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

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 Timeline

• Study Start: 2020-12-16
• Primary Completion: 2021-10-03
• Study Completion: 2022-01-05
• Study First Submitted: 2022-03-29
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin 10mg	Atraumatic Extraction and administration of SIMVASTATIN (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket.

Primary Outcome Measures

Name	Time	Method
Salivary BMP-2 Levels	At 40th Day of study	Mean values were measured using ELISA technique
Bone Density	At 40th day of study	Mean grey value were measured using imageJ software

Trial Locations

Locations (1)

Dental Department of Lahore General Hospital.; 🇵🇰 Lahore, Punjab, Pakistan