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

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04824898

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
Intra-bony Pockets	Drug: Simvastatin Other: injectable plasma rich fibrin	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Sep 20, 2022

Anticipated Study Completion Date :

Sep 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Plaque index (PI) [change from basline at 6 months]
clinical score
Gingival index (GI) [change from basline at 6 months]
clinical score
Probing depth (PD) [change from basline at 6 months]
clinical score
Clinical attachment level (CAL) [change from basline at 6 months]
clinical score

Secondary Outcome Measures

radiographIc [from baseline at 6 months]
assess the alveolar bone level radiographically

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 )

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	New Cairo	Egypt	1234

Sponsors and Collaborators

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