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

Intra-bony Pockets Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04824898
• Other study ID #: OMD-2019-1
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 20, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Intra-bony Pockets

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index (PI)	clinical score	change from basline at 6 months
Primary	Gingival index (GI)	clinical score	change from basline at 6 months
Primary	Probing depth (PD)	clinical score	change from basline at 6 months
Primary	Clinical attachment level (CAL)	clinical score	change from basline at 6 months
Secondary	radiographIc	assess the alveolar bone level radiographically	from baseline at 6 months