Clinical trial NCT04824898: The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Intra-bony Pockets
Keywords: intra-bony pocket
I-prf
infra-bony pocket defect
vertical bone loss treatment
simvastation in pockets
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 )

Primary outcomes:
measure: Plaque index (PI)
timeFrame: change from basline at 6 months
measure: Gingival index (GI)
timeFrame: change from basline at 6 months
measure: Probing depth (PD)
timeFrame: change from basline at 6 months
measure: Clinical attachment level (CAL)
timeFrame: change from basline at 6 months
Secondary outcomes:
measure: radiographIc
timeFrame: from baseline at 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: New Cairo
Study officials:
affiliation: faculty of dentistry ainshams university
name: suzan seif allah, professor
role: STUDY_DIRECTOR
affiliation: faculty of dentistry ainshams university
name: ola m ezzat, ass professor
role: STUDY_CHAIR
References: