Clinical trial NCT05369091: Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Injury
Keywords: Simvastatin
Salivary BMP-2
Radiographic Bone density
Lead sponsor: Postgraduate Medical Institute, Lahore
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary BMP-2 Levels
timeFrame: At start of study
measure: Salivary BMP-2 Levels
timeFrame: At 3rd day Of Study
measure: Salivary BMP-2 Levels
timeFrame: At 10th Day of study
measure: Salivary BMP-2 Levels
timeFrame: At 40th Day of study
measure: Bone Density
timeFrame: At start of study
measure: Bone Density
timeFrame: At 40th day of study
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Dental Department of Lahore General Hospital.
state: Punjab
Study officials:
affiliation: Pgmi. Lahore
name: shagufta nasreen
role: STUDY_CHAIR
References: