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

February 2, 2021 updated by: Najeeb Mohammed Mahyoub Ahmed, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Faculty of dentistry cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
CAL will be measured at base line, 3, 6, 9, 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PD will be measured at base line, 3, 6, 9, 12 months postoperative
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
RD will be measured at base line, 3, 6, 9, 12 months postoperative
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
IBD will be measured at base line, 3, 6, 9, 12 months postoperative
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?
After 12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Manal Hosny, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01091495663

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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