A Phase 4 interventional study of Simvastatin 10mg in Bone Injury, sponsored by Postgraduate Medical Institute, Lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Postgraduate Medical Institute, Lahore · Phase 4, Interventional, and Treatment
Salivary Bmp-2 Levels \& Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With \& Without topical Application Of Simvastatin
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.
Postgraduate Medical Institute, Lahore is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without 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.
Also known as: SIM
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Time frame: At start of study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Time frame: At 3rd day Of Study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Time frame: At 10th Day of study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Time frame: At 40th Day of study
Bone Density
Mean grey value were measured using imageJ software
Time frame: At start of study
Bone Density
Mean grey value were measured using imageJ software
Time frame: At 40th day of study
Plan to share: Undecided
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simvastatin
Postgraduate Medical Institute, Lahore