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The purpose of this clinical trial is to compare the results in subjects with periodontitis using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material, namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment of bone defects around the teeth.
After being informed about the study and potential risks, 13 patients giving written informed consent and who meet the eligibility requirements were randomly allocated in a single blind manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).
33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and radiographic outcomes obtained in test and control groups,12 months post - operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP combined with DFDBA | Experimental | Open flap debridement, followed by placement of PRP combined with DFDBA |
|
| DFDBA | Active Comparator | Open flap debridement, followed by placement of DFDBA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP combined with DFDBA | Other | Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth (PPD) from baseline to 12 months | PPD is vertical measurement from the free gingival margin to the base of the pocket measured to the nearest millimeter using a UNC (University of North Carolina) -15 periodontal probe. | baseline to 12 months |
| Change in Periodontal Attachment Level (PAL) from baseline to 12 months | PAL is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the base of the pocket measured to the nearest millimeter using UNC - 15 probe | baseline to 12 months |
| Change in Gingival Recession (GR) from baseline to 12 months | GR is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the gingival margin measured to the nearest millimeter using UNC-15 probe | baseline to 12 months |
| Change in Crestal bone resorption from baseline to 12 months | Crestal bone resorption is the distance from Cementoenamel Junction to the Alveolar Crest (CEJ- AC); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest | baseline to 12 months |
| Change in Defect fill from baseline to 12 months | Defect fill is the distance from Cementoenamel Junction to Base of the Defect (CEJ- BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest | baseline to 12 months |
| Change in Defect resolution from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Silness and Loe, 1964 | baseline to 12 months |
| Gingival Index | Loe and Silness, 1963 | baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pallavi A Meshram, MDS | Government Dental College and Hospital, Nagpur, India | Principal Investigator |
| Ramreddy K Yeltiwar, MDS | Rungta College of Dental Sciences and Research, Bhilai, India. | Study Chair |
| Mangesh B Phadnaik, MDS | Government Dental College and Hospital, Nagpur, India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 212, Department of Periodontology, Government Dental college and Hospital | Nagpur | Maharashtra | 440003 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16298220 | Background | Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8. | |
| 16686925 | Background | Polimeni G, Xiropaidis AV, Wikesjo UM. Biology and principles of periodontal wound healing/regeneration. Periodontol 2000. 2006;41:30-47. doi: 10.1111/j.1600-0757.2006.00157.x. No abstract available. |
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All collected Individual Participant Data
starting 6 months after publication
to other researchers
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| DFDBA | Other | Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA |
|
Defect resolution is the distance from the Alveolar Crest to Base of the Defect (AC - BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
| baseline to 12 months |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |