The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry

NCT ID: NCT04824898

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-09-20

Brief Summary

Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level.

and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called "blood concentrate ". So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,

Detailed Description

Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.

Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.

• Oral hygiene instructions will be given to all patients.
• Full mouth Scaling and root planing (SRP) will be performed under local anesthesia.
• 4 to 8 weeks after the non-surgical periodontal therapy patients will be reassessed clinically and radiographically For all patients who are suitable for the study the following clinical and radiographic evaluation parameters will be measured: (All parameters will be recorded Pre-operatively (base line) and 6 months Post operatively by an examiner who will be masked to the type of treatment received by the individuals).

Conditions

Intra-bony Pockets

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

simvastatin 1.2%gel

simvastatin 1.2%gel applied after open flap debridment in group I

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation

I-prf

Injectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment

Group Type: EXPERIMENTAL

injectable plasma rich fibrin

Intervention Type: OTHER

I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection

Interventions

Simvastatin

Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation

Intervention Type: DRUG

injectable plasma rich fibrin

I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection

Intervention Type: OTHER

Other Intervention Names

i-prf

Eligibility Criteria

Inclusion Criteria

• • Age range between 25 and 40 years

• Patients with severe chronic periodontitis having probing depth (PD) ≥6 mm and clinical attachment loss (CAL) ≥5 mm , or Stage III periodontitis
• Patient having vertical bone loss ≥3 mm (distance between alveolar crest and base of the defect as confirmed by preoperative intraoral periapical radiographs using standardized parallel technique.)
• Good compliance with the plaque control instructions following initial therapy
• Availability for follow up and maintenance program.

Exclusion Criteria

• • Patient with any systemic disease or conditions

• Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of trial and during the study.
• Patients who have undergone any periodontal treatment in the last 6 months
• Pregnant and Lactating.
• Reported allergy to any type of statins
• Subjects who were tobacco or alcohol users
• Vulnerable group of patients (e.g.: prisoners , handicapped , or decisionally impaired individuals )

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

suzan seif allah, professor

Role: STUDY_DIRECTOR

faculty of dentistry ainshams university

ola m ezzat, ass professor

Role: STUDY_CHAIR

faculty of dentistry ainshams university

Locations

Ain Shams University

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

OMD-2019-1

Identifier Type: -

Identifier Source: org_study_id