Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects.

Clinical and Radiographic Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial

Periodontal infections in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention. It is evident with the available data that PRF has antimicrobial activity against microbial pathogens. Clindamycin is an effective antibiotic against anaerobic bacteria and it achieves higher levels of antimicrobial activity than other antibiotics. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Intrabony Defects
• Intervention / Treatment: Procedure: M-MIST + Clindamycin augmented PRF; Procedure: M-MIST + PRF

Detailed Description

Many factors had to be taken into consideration while treating intrabony defects to achieve the concept of periodontal regeneration. PRF is a material that contains growth factors enmeshed in the fibrin network resulting in their sustained release over a period of time that can accelerate the wound healing process. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects. The purpose of combination between the PRF and Clindamycin is for establishing a simple and practical method that gives antimicrobial properties to PRF and to provide evidence of its effectiveness, and that this may provide additional advantage and reduces the need for systemic antibiotics in a variety of oral surgical procedures. Protection of the regenerating area should be provided through the specifically designed surgical approaches. These different surgical approaches developed over time include differences in terms of flap design and suturing technique. Therefore, successful wound healing was strongly influenced by preservation of the microvasculature of soft tissues as well as by revascularization rates. The Minimally Invasive Surgical Technique (MIST) was proposed by to draw the aspects of wound and blood clot stability and primary wound closure for blood-clot protection. These concepts were further strengthened with the Modified Minimally Invasive Surgical Technique M-MIST, that further incorporated the concept of space provision for the process of regeneration. For this, the effect of Clindamycin augmented PRF together with M-MIST on the clinical and radiographic outcomes in the treatment of periodontal intrabony defects need to be evaluated for clinical effectiveness

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Yusri; Phone Number: +201221036308; Email: sarah.elsayed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient-related criteria:

  • Patient consulting in the outpatient clinic.
  • Able to tolerate surgical periodontal procedures.
  • Patient ready to perform oral hygiene instructions.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the 12 months follow-up period.

• Teeth related criteria:

  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.

Exclusion Criteria:

• Patient-related criteria:

  • Medically compromised patients.
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Smokers.

• Teeth related criteria:

  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade II or III mobility.
  • Teeth with proximal carious defects or proximal faulty restorations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (M-MIST + Clindamycin augmented PRF); Patients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin.	Procedure: M-MIST + Clindamycin augmented PRF; modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin.
Experimental: Control group (M-MIST + PRF); Patients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with platelet-rich fibrin alone .	Procedure: M-MIST + PRF; modified minimally invasive surgical technique with platelet-rich fibrin alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level ( CAL)	Measured from the CEJ to the bottom of the gingival sulcus.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth (PD)	Measured from the gingival margin to the bottom of the gingival sulcus.	9 months
Radiographic linear defect depth	Measured as the depth of intra-osseous defect from the alveolar crest to the defect base	9 months
Radiographic defect bone density	The region of interest (ROI) is outlined, through drawing an outline corresponding to the demarcating walls of the intra-osseous defect and mean grey values are calculated	9 months
Gingival recession	Measured from the CEJ to the most apical extension of the gingival margin.	9 months
Plaque index	Scores 0,1,2,3	9 months
Gingival index	Scores 0,1,2,3	9 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Sarah Yusri, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Clindamycin; platelet-rich fibrin; intrabony defects; modified minimally invasive
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: PER332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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