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

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

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 .

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement; Procedure: Open flap debridement

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Group; Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).	Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement; 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.
ACTIVE_COMPARATOR: Control Group; Open flap debridement alone.	Procedure: Open flap debridement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Probing Depth (PD)	Probing depth measured from the gingival margin to the base of the pocket.	6 months
Gingival margin Level (GML)	• Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.	6 months

Collaborators and Investigators

• Sponsor: Hadeer Ashraf Hassan Roushdy

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (ACTUAL): January 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Furcation Defects
• Other Study ID Numbers: perio2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No