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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804086
• Other study ID #: perio2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: February 2020

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: February 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Furcation Defects
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadeer Ashraf Hassan Roushdy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Probing Depth (PD)	Probing depth measured from the gingival margin to the base of the pocket.	6 months
Secondary	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