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

Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03900013
Enrollment
20
Registered
2019-04-02
Start date
2019-09-20
Completion date
2021-12-20
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

Keywords

Injectable platelet rich fibrin, I-PRF, Demineralized Freeze-Dried Bone Allograft, DFDBA, Stage 3 periodontitis, 3 wall intraosseous defect, 2 wall intraosseous defect

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.

Interventions

PROCEDUREInjectable platelet rich fibrin combined with DFDBA

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

PROCEDUREDemineralized Freeze Dried Bone Allograft

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the type of intervention, only the outcome assessor and the statistician will be blinded.

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical attachment level gain (CAL)CAL will be measured at base line, 3, 6, and 9 months postoperativeCAL 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.

Secondary

MeasureTime frameDescription
Probing Depth (PD)PD will be measured at base line, 3, 6, and 9 months postoperativePD 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.
Radiographic defect fill (IBD)Radiographic defect fill will be measured at base line, 6, and 9 months postoperativeThe 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
Gingival Recession Depth (RD)RD will be measured at base line, 3, 6, and 9 months postoperativeRD 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.
Post-surgical patient satisfactionAfter 9 months postoperativeA 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026