Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth
NCT ID: NCT05369091
Last Updated: 2022-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2020-12-16
2022-01-05
Brief Summary
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Detailed Description
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'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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Placebo
Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN).
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
25 Years
ALL
Yes
Sponsors
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Postgraduate Medical Institute, Lahore
OTHER
Responsible Party
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Muhammad Mutahir Mehdi
M.Phil Oral Biology Trainee
Principal Investigators
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shagufta nasreen
Role: STUDY_CHAIR
Pgmi. Lahore
Locations
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Dental Department of Lahore General Hospital.
Lahore, Punjab Province, Pakistan
Countries
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Other Identifiers
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M.Phil Oral Biology Trainee
Identifier Type: -
Identifier Source: org_study_id
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