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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Clinical Effect of APRF With DFDBA Compare to Collagen Membrane With DFDBA in Intraosseous Defect

Clinicaltrials.gov identifier NCT03922503

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted April 22, 2019

Study Description

Brief summary:

to assess the effectiveness of advanced PRF in combination of Demineralized freeze-dried bone allograft (DFDBA) as compared to collagen membrane in combination with Demineralized freeze-dried bone allograft (DFDBA) treatment of non-contained periodontal intraosseous defects in stage III periodontitis patients.

  • Condition or Disease:Intrabony Periodontal Defect
  • Intervention/Treatment: Procedure: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)
    Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)
  • Phase: N/A
Detailed Description

Treatment of intraosseous periodontal defects represents a clinical challenge; these defects have been detected through clinical and radiographic examination in 18- 51 % of patients with periodontitis. They are often associated with persistent deep pockets and bleeding following conventional periodontal treatment. Complex regenerative periodontal therapy is advocated for management of these defects. The outcomes of regenerative periodontal therapy are positively correlated with the morphology of osseous defects. Non-contained defects are prevalent clinically and have been reported to have a low regenerative potential.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 22 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: A Randomized Clinical Trial
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Advanced- platelets rich fibrin with DFDBA
In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.
Procedure: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)
In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier.The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.
Active Comparator: Collagen membrane and DFDBA
After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)
After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Outcome Measures
  • Primary Outcome Measures: 1. Change in clinical attachment level (CAL) [ Time Frame: CAL will be measured at base line, 3, 6, 9, 12 months postoperative ]
    CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth.
  • Secondary Outcome Measures: 1. Pobing Depth (PD) [ Time Frame: PD will be measured at base line, 3, 6, 9, 12 months postoperative ]
    PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.
  • 2. Gingival Recession Depth (RD) [ Time Frame: RD will be measured at base line, 3, 6, 9, 12 months postoperative ]
    RD will be measured from the CEJ to the most apical extension of the gingival margin using UNC periodontal probe at six sites per tooth
  • 3. Radiographic defect fill (IBD) [ Time Frame: IBD will be measured at base line, 3, 6, 9, 12 months postoperative ]
    IBD will be measured from the alveolar bone crest to the base of the defect at baseline and after 6 months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiographs. Radiographs will be scanned and the radiographic IBD depth was measured by a computer-aided software program
  • 4. Post-surgical patient satisfaction [ Time Frame: After 12 months postoperative ]
    A 3-item questionnaire will be asked to the patients and shall use a 7-point 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?
Eligibility Criteria
  • Ages Eligible for Study: 25 to 50 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Stage III periodontitis patient having at least one tooth with one wall or combined1-
to 2-wall intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing,
radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth
(PD) ≥ 6 mm.

- Defect not extending to a root furcation area

- Vital teeth

- Non-smokers.

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

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

- Able to sign an informed consent form.

- Patients age between 25 and 50 years old.

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

- Systemically free according to Cornell Medical Index

Exclusion Criteria:

- Pregnancy or breast feeding

- The presence of an orthodontic appliance

- Teeth mobility greater than grade I

Contacts and Locations
Contacts

Contact: Najeeb M Mahyoub, Master 00201091495663 Najeeb.mahyoub@dentistry.cu.edu.eg

Contact: Manal Hosny, professor manhosny@gmail.com

Locations
Sponsors and Collaborators

Cairo University

Investigators

Study Director: Manal Hosny faculty of dentistry Cairo university

More Information