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

Cairo University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Injectable platelet rich fibrin combined with DFDBAPROCEDURE

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

Demineralized Freeze Dried Bone AllograftPROCEDURE

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Clinical attachment level gain (CAL)

CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

Time frame: CAL will be measured at base line, 3, 6, and 9 months postoperative

Secondary Outcomes

Probing Depth (PD)

PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

Time frame: PD will be measured at base line, 3, 6, and 9 months postoperative

Radiographic defect fill (IBD)

The depth of intrabony defect will be measured from the alveolar bone crest to the base of the defect at baseline, six months and after nine months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiograph. Radiographs will be scanned and the radiographic defect fill depth will be measured by a computer-aided software program

Time frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

Gingival Recession Depth (RD)

RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.

Time frame: RD will be measured at base line, 3, 6, and 9 months postoperative

Post-surgical patient satisfaction

A 3-item questionnaire will be asked to the patients and shall use a 7-points answer scale. These items will be: Would you experience the same surgery another time? Would you advice others with the surgery? To what extent are you satisfied with the results? 7 points mean the best 1 means the worst

Data from ClinicalTrials.gov

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