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

Bone Injury Clinical Trial

— salivaryBMP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369091
• Other study ID #: M.Phil Oral Biology Trainee
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2020
• Est. completion date: January 5, 2022

Study information

• Verified date: May 2022
• Source: Postgraduate Medical Institute, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 5, 2022
• Est. primary completion date: October 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Injury

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Dental Department of Lahore General Hospital.	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Medical Institute, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

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