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

NCT ID: NCT05369091

Last Updated: 2022-05-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2022-01-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Bone Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

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

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Simvastatin 10mg

Intervention Type 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.

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.

Intervention Type DRUG

Other Intervention Names

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SIM

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Medical Institute, Lahore

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Mutahir Mehdi

M.Phil Oral Biology Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Pakistan

Other Identifiers

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M.Phil Oral Biology Trainee

Identifier Type: -

Identifier Source: org_study_id

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