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

NCT05369091 | Completed Phase 4 DMC

• 1 other identifier: M.Phil Oral Biology Trainee
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Injury

Keywords

Simvastatin; Salivary BMP-2; Radiographic Bone density

Outcome Measures

Primary Outcomes (6)

• Salivary BMP-2 Levels

  Mean values were measured using ELISA technique

  At start of study

• Salivary BMP-2 Levels

  Mean values were measured using ELISA technique

  At 3rd day Of Study

• Salivary BMP-2 Levels

  Mean values were measured using ELISA technique

  At 10th Day of study

• Salivary BMP-2 Levels

  Mean values were measured using ELISA technique

  At 40th Day of study

• Bone Density

  Mean grey value were measured using imageJ software

  At start of study

• Bone Density

  Mean grey value were measured using imageJ software

  At 40th day of study

Study Arms (2)

Placebo

NO INTERVENTION

Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN).

Simvastatin

EXPERIMENTAL

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

Interventions

Simvastatin 10mg DRUG

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

Simvastatin

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

Dental Department of Lahore General Hospital.

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• shagufta nasreen

  Pgmi. Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Phil Oral Biology Trainee

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 11, 2022
• Study Start: December 16, 2020
• Primary Completion: October 3, 2021
• Study Completion: January 5, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

PA (1)