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

The Use of Injectable Plasma Rich Fibrin (I-PRF) Versus Simvastatin Gel in Surgical Management of Infra-bony Defects (A Randomized Controlled Clinical Trial)

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,

Study Overview

• Status: Active, not recruiting
• Conditions: Intra-bony Pockets
• Intervention / Treatment: Drug: Simvastatin; Other: injectable plasma rich fibrin

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 1234
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: simvastatin 1.2%gel; simvastatin 1.2%gel applied after open flap debridment in group I	Drug: 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
EXPERIMENTAL: I-prf; Injectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment	Other: 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; Other Names: i-prf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	clinical score	change from basline at 6 months
Gingival index (GI)	clinical score	change from basline at 6 months
Probing depth (PD)	clinical score	change from basline at 6 months
Clinical attachment level (CAL)	clinical score	change from basline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographIc	assess the alveolar bone level radiographically	from baseline at 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: suzan seif allah, professor, Faculty of dentistry AinShams University; Study Chair: ola m ezzat, ass professor, Faculty of dentistry AinShams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ANTICIPATED): September 20, 2022
• Study Completion (ANTICIPATED): September 20, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: intra-bony pocket; I-prf; infra-bony pocket defect; vertical bone loss treatment; simvastation in pockets
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: OMD-2019-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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