salivaryBMP2: Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth

• Sponsor: Postgraduate Medical Institute, Lahore (Other)
• Overall Status: Completed
• CT.gov ID: NCT05369091
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bone Injury	Drug: Simvastatin 10mg	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 16, 2020
• Actual Primary Completion Date: Oct 3, 2021
• Actual Study Completion Date: Jan 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Placebo Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN).
Experimental: 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.; Other Names: SIM

Outcome Measures

Primary Outcome Measures

1. Salivary BMP-2 Levels [At start of study]

   Mean values were measured using ELISA technique

2. Salivary BMP-2 Levels [At 3rd day Of Study]

   Mean values were measured using ELISA technique

3. Salivary BMP-2 Levels [At 10th Day of study]

   Mean values were measured using ELISA technique

4. Salivary BMP-2 Levels [At 40th Day of study]

   Mean values were measured using ELISA technique

5. Bone Density [At start of study]

   Mean grey value were measured using imageJ software

6. Bone Density [At 40th day of study]

   Mean grey value were measured using imageJ software

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Department of Lahore General Hospital.	Lahore	Punjab	Pakistan

Sponsors and Collaborators

• Postgraduate Medical Institute, Lahore

Investigators

• Study Chair: shagufta nasreen, Pgmi. Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Mutahir Mehdi, M.Phil Oral Biology Trainee, Postgraduate Medical Institute, Lahore
• ClinicalTrials.gov Identifier: NCT05369091
• Other Study ID Numbers: M.Phil Oral Biology Trainee
• First Posted: May 11, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Muhammad Mutahir Mehdi, M.Phil Oral Biology Trainee, Postgraduate Medical Institute, Lahore: Simvastatin; Salivary BMP-2; Radiographic Bone density
• Additional relevant MeSH terms: Simvastatin

Study Results

No Results Posted as of May 11, 2022