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

Periodontal Intrabony Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05177198
• Other study ID #: PER332
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: Sarah Yusri
• Phone: +201221036308
• Email: sarah.elsayed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Intrabony Defects

Intervention

Procedure:
• M-MIST + Clindamycin augmented PRF
modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin.
• M-MIST + PRF
modified minimally invasive surgical technique with platelet-rich fibrin alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level ( CAL)	Measured from the CEJ to the bottom of the gingival sulcus.	9 months
Secondary	Probing Depth (PD)	Measured from the gingival margin to the bottom of the gingival sulcus.	9 months
Secondary	Radiographic linear defect depth	Measured as the depth of intra-osseous defect from the alveolar crest to the defect base	9 months
Secondary	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
Secondary	Gingival recession	Measured from the CEJ to the most apical extension of the gingival margin.	9 months
Secondary	Plaque index	Scores 0,1,2,3	9 months
Secondary	Gingival index	Scores 0,1,2,3	9 months