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NCT Number: NCT03924336

The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.

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Key information

Conditions

Intrabony Periodontal Defect Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, 12613, Egypt

About this study

The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement.

A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Non-smokers.
  • No history of intake of medications affecting the periodontium in the previous 6 months.
  • Able to sign an informed consent form.
  • Patients age between 18 and 60 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index (Broadbent, 1951).

Exclusion criteria

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I

Treatment and study plan

Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)

Procedure

Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures

Open flap debridement (OFD) alone

Procedure

Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.

Primary outcomes

  1. Clinical Attachment Level (CAL) gain

    Time frame: Change from Baseline Clinical Attachment Level (CAL) at 9 months

    Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth

Secondary outcomes

  1. Probing Depth (PD)

    Time frame: Probing Depth will be measured at base line,3,6, and 9 months postoperative

    Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth

  2. Radiographic defect fill

    Time frame: Radiographic defect fill will be measured at 6,9,months

    The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiographs. Radiographs will be scanned and the radiographic (intrabony defect) IBD depth was measured by a computer-aided software program

  3. Gingival Recession Depth (RD)

    Time frame: Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative

    Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of CAL Gain Following Treatment of Intraosseous Defects With A-PRF+ Compared to Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2019
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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