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

NCT05177198 | Unknown DMC

• 1 other identifier: PER332
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontal Intrabony Defects

Keywords

modified minimally invasive; Clindamycin; platelet-rich fibrin; intrabony defects

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level ( CAL)

  Measured from the CEJ to the bottom of the gingival sulcus.

  9 months

Secondary Outcomes (6)

• Probing Depth (PD)

  9 months

• Radiographic linear defect depth

  9 months

• Radiographic defect bone density

  9 months

• Gingival recession

  9 months

• Plaque index

  9 months

Study Arms (2)

Test group (M-MIST + Clindamycin augmented PRF)

EXPERIMENTAL

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

Control group (M-MIST + PRF)

EXPERIMENTAL

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

Interventions

M-MIST + Clindamycin augmented PRF PROCEDURE

modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin.

Test group (M-MIST + Clindamycin augmented PRF)

M-MIST + PRF PROCEDURE

modified minimally invasive surgical technique with platelet-rich fibrin alone.

Control group (M-MIST + PRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Sarah Yusri

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Yusri

CONTACT

+201221036308; sarah.elsayed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Student at Cairo University

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: February 11, 2022

Record last verified: 2021-12