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The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

Primary Purpose

Intrabony Periodontal Defect

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)
Open flap debridement (OFD) alone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrabony Periodontal Defect focused on measuring stage 3 periodontitis, A-PRF, Advanced platelet rich fibrin, open flap debridement, OFD, 2-wall intraosseous defect, 3-wall intraosseous defect

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Stage 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 (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Non-smokers.
  • No history of intake of medications affecting the periodontium in the previous 6 months.
  • Able to sign an informed consent form.
  • Patients age between 18 and 60 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index (Broadbent, 1951).

Exclusion Criteria:

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I

Sites / Locations

  • Faculty of Dentistry Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Advanced- platelets rich fibrin plus with open flap debridement

Open flap debridement (OFD)

Arm Description

Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, A-PRF+ of the required size will be filled into the intraosseous defect, the mucoperiosteal flaps will be repositioned and secured in place using 4-0 silk sutures

Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, The interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.

Outcomes

Primary Outcome Measures

Clinical Attachment Level (CAL) gain
Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth

Secondary Outcome Measures

Probing Depth (PD)
Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth
Radiographic defect fill
The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six 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 (intrabony defect) IBD depth was measured by a computer-aided software program
Gingival Recession Depth (RD)
Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth

Full Information

First Posted
April 17, 2019
Last Updated
April 17, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03924336
Brief Title
The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis
Official Title
Evaluation of CAL Gain Following Treatment of Intraosseous Defects With A-PRF+ Compared to Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.
Detailed Description
The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement. A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrabony Periodontal Defect
Keywords
stage 3 periodontitis, A-PRF, Advanced platelet rich fibrin, open flap debridement, OFD, 2-wall intraosseous defect, 3-wall intraosseous defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Due to the type of intervention only the outcome assessor and the statistician will be blinded.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced- platelets rich fibrin plus with open flap debridement
Arm Type
Experimental
Arm Description
Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, A-PRF+ of the required size will be filled into the intraosseous defect, the mucoperiosteal flaps will be repositioned and secured in place using 4-0 silk sutures
Arm Title
Open flap debridement (OFD)
Arm Type
Active Comparator
Arm Description
Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, The interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Intervention Type
Procedure
Intervention Name(s)
Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)
Intervention Description
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD) alone
Intervention Description
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Primary Outcome Measure Information:
Title
Clinical Attachment Level (CAL) gain
Description
Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth
Time Frame
Change from Baseline Clinical Attachment Level (CAL) at 9 months
Secondary Outcome Measure Information:
Title
Probing Depth (PD)
Description
Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth
Time Frame
Probing Depth will be measured at base line,3,6, and 9 months postoperative
Title
Radiographic defect fill
Description
The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six 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 (intrabony defect) IBD depth was measured by a computer-aided software program
Time Frame
Radiographic defect fill will be measured at 6,9,months
Title
Gingival Recession Depth (RD)
Description
Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth
Time Frame
Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stage 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 (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm. Defect not extending to a root furcation area Non-smokers. No history of intake of medications affecting the periodontium in the previous 6 months. Able to sign an informed consent form. Patients age between 18 and 60 years old. Patients who are cooperative, motivated, and hygiene conscious. Systemically free according to Cornell Medical Index (Broadbent, 1951). Exclusion Criteria: Pregnancy or breast feeding The presence of an orthodontic appliance Teeth mobility greater than grade I
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hosny, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25867990
Citation
Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.
Results Reference
result
PubMed Identifier
26809431
Citation
Kobayashi E, Fluckiger L, Fujioka-Kobayashi M, Sawada K, Sculean A, Schaller B, Miron RJ. Comparative release of growth factors from PRP, PRF, and advanced-PRF. Clin Oral Investig. 2016 Dec;20(9):2353-2360. doi: 10.1007/s00784-016-1719-1. Epub 2016 Jan 25.
Results Reference
result

Learn more about this trial

The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

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