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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
212, Department of Periodontology, Government Dental college and Hospital
Nagpur, Maharashtra, India
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 12 months
Change in Defect resolution from baseline to 12 months
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
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Time frame: baseline to 12 months
Plaque Index
Silness and Loe, 1964
Time frame: baseline to 12 months
Gingival Index
Loe and Silness, 1963
Time frame: baseline to 12 months