PRF vs EMD periodontal regenerative surgery : a double blind, randomized controlled trial on the treatment of furcation II involved molars

PRF vs EMD periodontal regenerative surgery : a double blind, randomized controlled trial on the treatment of furcation II involved molars - PRF in periodontal regenerative surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46398

Enrollment

Registered

2018-04-25

Start date

2018-09-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic adult periodontitis periodontal disease periodontitis

Interventions

PRF preparation The A-PRF+ will be prepared according the recently introduced spinning protocol. Sterile plain glass-based vacuum tubes (A-PRF+ 10 mL tube) are used, and the centrifugation protocol

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-80. Presence of at least one molar with furcation involvement 2 , with horizontal AL >3 mm and residual pocket after non-surgical therapy of >5 mm.

Exclusion criteria

Exclusion criteria: On a patient level: Uncontrolled diabetes, HIV, leukopenia, or any systemic diseases related to reduced healing potential. Allergy to any medication related with the study protocol (Paracetamol, Xilocaine). Pregnancy or lactation. Daily use of any medication suppressive for the immune system like corticosteroid or immunosuppressant. Antibiotics use before the study enrolment. ;On tooth level: Third molars. Terminal bone loss. Endodontically and non-Endodontically treated teeth with periapical radiolucency. Periapical radiolucency or vertical fracture. Mobility >1. Furcation involvement grade 0 or 1.

Design outcomes

Primary

Measure	Time frame
The primary aim is to evaluate if the adjunctive use of PRF during periodontal surgery (Open Flap Debridement + PRF) and the adjunctive use of EMD (Open Flap Debridement + EMD) improves the clinical outcomes (horizontal clinical attachment level, probing pocket depth, vertical clinical attachment level, bleeding on probing, bone fill) of furcation involved molars, compared to Open Flap Debridement alone (OFD).	—

Measure

Time frame

The primary aim is to evaluate if the adjunctive use of PRF during periodontal surgery (Open Flap Debridement + PRF) and the adjunctive use of EMD (Open Flap Debridement + EMD) improves the clinical outcomes (horizontal clinical attachment level, probing pocket depth, vertical clinical attachment level, bleeding on probing, bone fill) of furcation involved molars, compared to Open Flap Debridement alone (OFD).

—

Secondary

Measure	Time frame
The secondary aim is to clinically assess the wound healing process and to evaluate patient*s acceptance and morbidity of the different surgical procedures. The tertiary aim is to investigate a possible correlation of systemic (peripheral blood) and local (gingival crevicular fluid) immunological responses with the quality of early wound healing evaluation and final clinical results.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)