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Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement
Open flap debridement
Sponsored by
Hadeer Ashraf Hassan Roushdy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient-related criteria:

  • Systemically healthy patients.
  • Compliance with oral hygiene instructions and the maintenance program provided.
  • Accepts the 6 months follow-up period.
  • Provide informed consent.

Teeth related criteria:

  • Mature permanent tooth.
  • Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
  • Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
  • Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

Exclusion Criteria:

Patient-related criteria:

  • Patients taking drugs known to interfere with periodontal wound healing in the last six months.
  • Pregnant or nursing women.
  • Smokers.
  • Uncooperative patients.

Teeth related criteria:

  • Teeth with interproximal supra-bony or intrabony defects.
  • Teeth with gingival recession.
  • Teeth with grade II or III mobility.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test Group

    Control Group

    Arm Description

    Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).

    Open flap debridement alone.

    Outcomes

    Primary Outcome Measures

    Relative Vertical Clinical Attachment Level (RVCAL)
    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe

    Secondary Outcome Measures

    Relative Horizontal Clinical Attachment Level (PHCAL)
    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
    Probing Depth (PD)
    Probing depth measured from the gingival margin to the base of the pocket.
    Gingival margin Level (GML)
    • Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.

    Full Information

    First Posted
    January 11, 2019
    Last Updated
    January 15, 2019
    Sponsor
    Hadeer Ashraf Hassan Roushdy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03804086
    Brief Title
    Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects
    Official Title
    Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hadeer Ashraf Hassan Roushdy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects. In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Group
    Arm Type
    Experimental
    Arm Description
    Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Open flap debridement alone.
    Intervention Type
    Procedure
    Intervention Name(s)
    Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement
    Intervention Description
    will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant. The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature. After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open flap debridement
    Intervention Description
    a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.
    Primary Outcome Measure Information:
    Title
    Relative Vertical Clinical Attachment Level (RVCAL)
    Description
    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Relative Horizontal Clinical Attachment Level (PHCAL)
    Description
    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
    Time Frame
    6 months
    Title
    Probing Depth (PD)
    Description
    Probing depth measured from the gingival margin to the base of the pocket.
    Time Frame
    6 months
    Title
    Gingival margin Level (GML)
    Description
    • Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient-related criteria: Systemically healthy patients. Compliance with oral hygiene instructions and the maintenance program provided. Accepts the 6 months follow-up period. Provide informed consent. Teeth related criteria: Mature permanent tooth. Asymptomatic mandibular molar with buccal Glickman class II furcation involvement. Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing). Presence of radiolucency in the furcation area on an intra-oral periapical radiograph Exclusion Criteria: Patient-related criteria: Patients taking drugs known to interfere with periodontal wound healing in the last six months. Pregnant or nursing women. Smokers. Uncooperative patients. Teeth related criteria: Teeth with interproximal supra-bony or intrabony defects. Teeth with gingival recession. Teeth with grade II or III mobility.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects

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