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

NCT04824898 | Unknown Phase 1 DMC

• 1 other identifier: OMD-2019-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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,

Conditions

Intra-bony Pockets

Keywords

intra-bony pocket; I-prf; infra-bony pocket defect; vertical bone loss treatment; simvastation in pockets

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• radiographIc

  from baseline at 6 months

Study Arms (2)

simvastatin 1.2%gel

EXPERIMENTAL

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

Drug: Simvastatin

I-prf

EXPERIMENTAL

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

Interventions

Simvastatin 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

simvastatin 1.2%gel

injectable plasma rich fibrin 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

Also known as: i-prf

I-prf

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, New Cairo, 1234, Egypt

Location

MeSH Terms

Interventions

Simvastatin; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

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

Study Officials

• suzan seif allah, professor

  faculty of dentistry ainshams university

  STUDY DIRECTOR

• ola m ezzat, ass professor

  faculty of dentistry ainshams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 1, 2021
• Study Start: January 20, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)