Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects (PRFMMFD)
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Furcation treatment with PRF
Furcation Treatment with Allograft and GTR
allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
autologous platelet-rich fibrin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Clinical Parameters, Furcation defects, Radiographic bone fill
Eligibility Criteria
Inclusion Criteria:
- One or more sites showing grade II furcation involvement in mandibular molars, with Probing pocket depth ≥ 5mm
- Vertical attachment level and horizontal level ≥3mm were considered.
- Patients who were systemically healthy, with no history of endodontic and periodontal treatment for the last 6 months, and no antibiotic usage for the last 6 months were included in the study. Care was taken to ascertain that the samples taken for the study were not allergic to any drugs nor to the graft materials used.
Exclusion Criteria:
- Patients with a history of diabetes, hypertension, on anticoagulant or steroid therapy (which could alter the effects of PRF), cardiac diseases, insufficient platelet counts and immunocompromised individuals were excluded from the study.
- Care was taken to exclude pregnant women and lactating mothers, smokers, patients with previous history of graft placement in the experimental site, and importantly those patients who were unable to maintain good oral hygiene (PI Score ≥ 1.5).
- If Grade II mobility was observed after phase I therapy in the experimental teeth, they were excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
11 Patients with Grade II Manibular Molar Furcation
11 Patients with Grade II Mandibular Molar Furcation D
Arm Description
Group A- Furcation Treatment with PRF
Group B- Furcation Treatment with Allograft and GTR
Outcomes
Primary Outcome Measures
Vertical clinical attacment level
The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery
Horizontal clinical attachment level
The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.
Bone fill
Bone fill was assessed radiographically and 9 months after surgery
Secondary Outcome Measures
Plaque Index
Plaque index was assessed preoperatively and 9 months after surgery
Probing depth
Probing depth was assessed preoperatively and 9 months after surgery
Gingival marginal level
Gingival marginal level was assessed preoperatively and 9 months after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02430519
Brief Title
Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects
Acronym
PRFMMFD
Official Title
Effect of Autologous Platelet Rich Fibrin In Human Mandibular Molar Grade II Furcation Defects- A Clinical and Radiological Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.Syed Asimuddin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane.
Detailed Description
ABSTRACT Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane. MATERIALS AND METHODS: The study was designed as a randomized, prospective, parallel-arm, interventional clinical trial wherein 30 patients with periodontitis and grade II Mandibular furcation defects attending the Out Patient wing of the Department of Periodontics of a tertiary referral care hospital were equally divided into group A and group B. Patients in.Group A, were treated by the placement of PRF as a Graft and as a membrane at the surgical site , while in Group B, the defects were treated by the placement of Allograft and Healiguide collagen membrane. Plaque Index, Probing depth, Vertical clinical attachment level, Horizontal clinical attachment level, Gingival marginal level, and amount of bonefill using Radiovisiography were recorded at baseline and 9 months. Intra-group comparison of Mean scores between Group A and Group B was done using Paired t test and Inter-group comparison using independent sample t test. CONCLUSION Further studies evaluating the efficacy of PRF using a larger sample size should be performed to evaluate its true beneficial effects on long term basis in patients with mandibular molar Grade 2 furcation defects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic Periodontitis, Clinical Parameters, Furcation defects, Radiographic bone fill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, parallel arm, interventional trial
Masking
ParticipantInvestigator
Masking Description
The eligible samples were screened and randomly assigned by lottery method by investigator KRR into PRF (Group A) and GTR + Allograft (Group B). The treatment was performed by investigator SA who was blinded to the randomization process
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11 Patients with Grade II Manibular Molar Furcation
Arm Type
Experimental
Arm Description
Group A- Furcation Treatment with PRF
Arm Title
11 Patients with Grade II Mandibular Molar Furcation D
Arm Type
Experimental
Arm Description
Group B- Furcation Treatment with Allograft and GTR
Intervention Type
Procedure
Intervention Name(s)
Furcation treatment with PRF
Other Intervention Name(s)
Furcation Management with Platelet rich fibrin
Intervention Description
PRF Placed into the furcation after flap elevation and debridement
Intervention Type
Procedure
Intervention Name(s)
Furcation Treatment with Allograft and GTR
Other Intervention Name(s)
Furcation Management with DFDBM and Healiguide
Intervention Description
Allograft and GTR placed into furcation after flap elevation and debridement
Intervention Type
Device
Intervention Name(s)
allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)
Intervention Type
Device
Intervention Name(s)
autologous platelet-rich fibrin
Primary Outcome Measure Information:
Title
Vertical clinical attacment level
Description
The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery
Time Frame
9 months Post treatment
Title
Horizontal clinical attachment level
Description
The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery.
Time Frame
9 months Post treatment
Title
Bone fill
Description
Bone fill was assessed radiographically and 9 months after surgery
Time Frame
9 months Post treatment
Secondary Outcome Measure Information:
Title
Plaque Index
Description
Plaque index was assessed preoperatively and 9 months after surgery
Time Frame
9 Months Post treatment
Title
Probing depth
Description
Probing depth was assessed preoperatively and 9 months after surgery
Time Frame
9 Months Post treatment
Title
Gingival marginal level
Description
Gingival marginal level was assessed preoperatively and 9 months after surgery
Time Frame
9 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
One or more sites showing grade II furcation involvement in mandibular molars, with Probing pocket depth ≥ 5mm
Vertical attachment level and horizontal level ≥3mm were considered.
Patients who were systemically healthy, with no history of endodontic and periodontal treatment for the last 6 months, and no antibiotic usage for the last 6 months were included in the study. Care was taken to ascertain that the samples taken for the study were not allergic to any drugs nor to the graft materials used.
Exclusion Criteria:
Patients with a history of diabetes, hypertension, on anticoagulant or steroid therapy (which could alter the effects of PRF), cardiac diseases, insufficient platelet counts and immunocompromised individuals were excluded from the study.
Care was taken to exclude pregnant women and lactating mothers, smokers, patients with previous history of graft placement in the experimental site, and importantly those patients who were unable to maintain good oral hygiene (PI Score ≥ 1.5).
If Grade II mobility was observed after phase I therapy in the experimental teeth, they were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha R Koduganti, MDS(Perio)
Organizational Affiliation
Prof & HOD,Dept of Periodontics,Panineeya Institute of dental sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Syed Asimuddin, MDS(Perio)
Organizational Affiliation
PG Student,Panineeya Institute of Dental Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16504852
Citation
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
Results Reference
result
PubMed Identifier
19878476
Citation
Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.
Results Reference
result
PubMed Identifier
9205924
Citation
Luepke PG, Mellonig JT, Brunsvold MA. A clinical evaluation of a bioresorbable barrier with and without decalcified freeze-dried bone allograft in the treatment of molar furcations. J Clin Periodontol. 1997 Jun;24(6):440-6. doi: 10.1111/j.1600-051x.1997.tb00209.x.
Results Reference
result
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Benefits of Platelet Rich Fibrin In Mandibular Molar Furcation Defects
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