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Completed

NCT Number: NCT05369091

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

Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With & Without topical Application Of Simvastatin

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Department of Lahore General Hospital.

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SIM

Primary outcomes

  1. Salivary BMP-2 Levels

    Time frame: At start of study

    Mean values were measured using ELISA technique

  2. Salivary BMP-2 Levels

    Time frame: At 3rd day Of Study

    Mean values were measured using ELISA technique

  3. Salivary BMP-2 Levels

    Time frame: At 10th Day of study

    Mean values were measured using ELISA technique

  4. Salivary BMP-2 Levels

    Time frame: At 40th Day of study

    Mean values were measured using ELISA technique

  5. Bone Density

    Time frame: At start of study

    Mean grey value were measured using imageJ software

  6. Bone Density

    Time frame: At 40th day of study

    Mean grey value were measured using imageJ software

Sponsors and collaborators

Lead sponsor

Postgraduate Medical Institute, Lahore

Other

Registry information

Official study title

Salivary Bmp-2 Levels And Radiographic Measurement Of Bone Density At Extracted Tooth Socket In Patients With And Without Topical Application Of Simvastatin

Acronym: salivaryBMP2

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 11, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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