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
About this trial
This is an interventional treatment trial for Periodontitis
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.
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
NCT ID
NCT03804086
First Posted
January 11, 2019
Last Updated
January 15, 2019
Sponsor
Hadeer Ashraf Hassan Roushdy
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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