Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects
Primary Purpose
Periodontal Diseases, Bone Resorption
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Platelet rich fibrin
Bioactive Glass
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal disease, Platelet rich fibrin
Eligibility Criteria
Inclusion Criteria:
- The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects.
Exclusion Criteria:
- Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet rich Fibrin
Bioactive glass
Arm Description
The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.
The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone
Outcomes
Primary Outcome Measures
Intrabony defect fill
change in intrabony defect fill from baseline to 9 months
Secondary Outcome Measures
Probing depth
change in probing depth from baseline to 9 months
Clinical attachment level
change in Clinical attachment level from baseline to 9 months
Gingival Index
change in Gingival Index from baseline to 9 months
Full Information
NCT ID
NCT02982681
First Posted
December 1, 2016
Last Updated
December 1, 2016
Sponsor
Dr. D. Y. Patil Dental College & Hospital
Collaborators
Santosh University
1. Study Identification
Unique Protocol Identification Number
NCT02982681
Brief Title
Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects
Official Title
COMPARATIVE EVALUATION OF BIOACTIVE GLASS PUTTY AND PLATELET RICH FIBRIN IN THE TREATMENT OF HUMAN PERIODONTAL INTRABONY DEFECTS- A CLINICAL AND RADIOGRAPHICAL STUDY"
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital
Collaborators
Santosh University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be effective in promoting reduction in probing depth, gain in clinical attachment, and defect fill in intrabony periodontal defects. The individual role played by bioactive glass putty in combination with PRF is yet to be elucidated.
AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects in humans.
Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on other side. The primary outcomes of the study included changes in probing depth, attachment level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3, 6, and 9 months. Radiographic assessment was done using standardized intra oral periapical radiographs. Comparisions were made within each group between baseline, 3 months, 6 months and 9 months using the ANOVA test followed by Bonferroni test.
Detailed Description
INTRODUCTION
Periodontitis is an infectious disease that causes destruction of the attachment apparatus.[1].The mainstay aim of periodontal treatment is the regeneration of the lost attachment apparatus of the teeth. Variety of treatment modalities are available for periodontal regenerative therapy including bone grafts, bone substitutes, Guided Tissue Regeneration, growth factors, application of tissue engineering or the combination of two or more of the above listed approaches. [2] Alloplasts, may be an effective alternative to allograft and xenografts as there is no risk of disease transmission and the supply is unlimited.[3] The Bioactive glass promotes osteogenesis by adsorption and concentrations of protein utilized by osteoblast to form a mineralized extracellular matrix. [4] The advantage of the putty form of bioactive glass is the glycerine and polyethylene glycol which makes the glass particle coherent and thus enhancing handling characteristics and minimal migration of graft particles from the defect site. [5] Histological evaluation of material has shown that the particulate tends to retard the down growth of epithelial tissue. [6,7,8,9] Growth factors play a pivotal role in periodontal regeneration. Platelet Rich Fibrin is believed to release polypeptide growth factors, such as transforming growth factors-ß, platelet derived growth factors, vascular endothelial growth factors and matrix glycoproteins (such as thrombospondin -1) into the surgical wound in a sustained fashion for at least 7 days as shown in vitro. [10] Thus, given the unique graft with osteoconductive, osteoinductive and osteostimulative properties and properties of autologous PRF, application of combination approach was attempted for the assessment of their additional benefits to the healing mechanisms and periodontal regeneration in intrabony defects.
Materials and methods Patient Selection This randomized control trial was carried out in the Department of Periodontics and Oral Implantology, Santosh Dental College and Hospital, Santosh University, Ghaziabad. Ten patients suffering chronic localized periodontitis aged between 20 -50 years (7 males and 3 females) with 10 pairs of contalateral intraosseous defects (n=20) comprised the study population. A total of 20 bone defects (10 pairs) were decided by the statisticion to be of statistical strength. Convenient sampling design was used for the enrolment of study patients. Ethical approval was taken from the institutional ethical committee The patients were explained in detail about the procedure and a written informed consent was taken. The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects. [3] Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.
PRESURGICAL THERAPY Patients underwent phase I therapy. The selected defects were evaluated after 2 weeks, and persistent pockets > or = 5mm and patients with clinical radiographic evidence of angular osseous defects were scheduled for surgery.
Clinical Parameters :
Oral hygiene status was recorded using the gingival index of Loe & Sillness,[11];
with score 0 indicating absence of inflammation and score 3 indicating severe
inflammation and plaque index of Silness & Loe. [12]
Probing pocket depth and Clinical attachment level were recorded at baseline on the
day of surgery, 3, 6 and 9 months intervals using UNC-15 probe and customized
acrylic occlusal stents grooved in the area of defect to provide reproducible insertion
axis-
The following measurements were recorded with customized
acrylic stent:
Fixed reference point (FRP) to the base of pocket (BP)
Fixed reference point (FRP) to the cemento-enamel junction (CEJ)
Fixed reference point (FRP) to the gingival margin (GM)
PPD and CAL were calculated from these probing measurements as:
PPD = (FRP to BP) - (FRP to GM)
CAL= (FRP to BP) - (FRP to CEJ)
Radiographic measurements: Standardized intra-oral periapical radiographs of the defects were taken using a paralleling technique.[13]
Amount of defect fill: Defects were measured from the fixed reference point (distance between the cemento-enamel junction to the radiographic base of the bone defect ) with the help of 1.1 mm grid and the following radiographic features were recorded on the day of surgery, 3, 6 and 9 months intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Bone Resorption
Keywords
Periodontal disease, Platelet rich fibrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich Fibrin
Arm Type
Experimental
Arm Description
The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.
Arm Title
Bioactive glass
Arm Type
Active Comparator
Arm Description
The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone
Intervention Type
Drug
Intervention Name(s)
Platelet rich fibrin
Other Intervention Name(s)
PRF
Intervention Description
In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site
Intervention Type
Drug
Intervention Name(s)
Bioactive Glass
Other Intervention Name(s)
Novabone
Intervention Description
The control site were packed with the bioactive glass graft alone
Primary Outcome Measure Information:
Title
Intrabony defect fill
Description
change in intrabony defect fill from baseline to 9 months
Time Frame
baseline to 9 months
Secondary Outcome Measure Information:
Title
Probing depth
Description
change in probing depth from baseline to 9 months
Time Frame
baseline to 9 months
Title
Clinical attachment level
Description
change in Clinical attachment level from baseline to 9 months
Time Frame
baseline to 9 months
Title
Gingival Index
Description
change in Gingival Index from baseline to 9 months
Time Frame
baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects.
Exclusion Criteria:
Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.
12. IPD Sharing Statement
Citations:
PubMed Identifier
10368057
Citation
Hall EE, Meffert RM, Hermann JS, Mellonig JT, Cochran DL. Comparison of bioactive glass to demineralized freeze-dried bone allograft in the treatment of intrabony defects around implants in the canine mandible. J Periodontol. 1999 May;70(5):526-35. doi: 10.1902/jop.1999.70.5.526.
Results Reference
background
PubMed Identifier
19089687
Citation
Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
Results Reference
background
Learn more about this trial
Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects
We'll reach out to this number within 24 hrs