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

Not Applicable

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

• Registration Number: NCT03804086
• Lead Sponsor: Hadeer Ashraf Hassan Roushdy

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17
• Study Start: 2019-02
• Primary Completion: 2019-11
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement	Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).
Control Group	Open flap debridement	Open flap debridement alone.

Primary Outcome Measures

Name	Time	Method
Relative Vertical Clinical Attachment Level (RVCAL)	6 months	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

Name	Time	Method
Relative Horizontal Clinical Attachment Level (PHCAL)	6 months	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)	6 months	Probing depth measured from the gingival margin to the base of the pocket.
Gingival margin Level (GML)	6 months	• Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.