Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

NCT ID: NCT03900013

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2021-12-20

Brief Summary

Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.

Detailed Description

Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Conditions

Intrabony Periodontal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Injectable Platelet Rich Fibrin (i-PRF) with DFDBA

In i-PRF assigned group, 10 cc of blood per intraosseous defect will be collected right after administering the anaesthesia and will be processed according to the technique proposed by Choukroun et al., 2017 (centrifuged at 700 rpm, for 2-3 minutes). The yellow part will be collected using a syringe and added to a cup that contains the bone grafting material.

The i-PRF consolidated bone graft will placed into the intraosseous defect.

Group Type: EXPERIMENTAL

Injectable platelet rich fibrin combined with DFDBA

Intervention Type: PROCEDURE

The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect

Demineralized Freeze-Dried Bone Allograft (DFDBA) alone

After debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling.

Group Type: ACTIVE_COMPARATOR

Demineralized Freeze Dried Bone Allograft

Intervention Type: PROCEDURE

Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect

Interventions

Injectable platelet rich fibrin combined with DFDBA

The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect

Intervention Type: PROCEDURE

Demineralized Freeze Dried Bone Allograft

Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Type III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level ≥ 5 mm and pocket depth ≥ 6 mm.

2. Defect not extending to a root furcation area

3. Vital teeth

4. Non-smokers.

5. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.

6. No periodontal therapy carried out in the past 6 months.

7. Able to sign an informed consent form.

8. Patients age between 25 and 50 years old.

9. Patients who are cooperative, motivated, and hygiene conscious.

10. Systemically free according to Cornell Medical Index

Exclusion Criteria

1. Pregnancy or breast feeding

2. The presence of an orthodontic appliance

3. Teeth mobility greater than grade I

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mashaal Mohammed Abdullah Mohammed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal Hosny, Professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Countries

Egypt

References

Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Chenchev IL, Ivanova VV, Neychev DZ, Cholakova RB. Application of Platelet-Rich Fibrin and Injectable Platelet-Rich Fibrin in Combination of Bone Substitute Material for Alveolar Ridge Augmentation - a Case Report. Folia Med (Plovdiv). 2017 Sep 1;59(3):362-366. doi: 10.1515/folmed-2017-0044.

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Reference Type: BACKGROUND

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Other Identifiers

MASH2019

Identifier Type: -

Identifier Source: org_study_id