Chronic Periodontitis
Conditions
Keywords
platelet - rich plasma, demineralized freeze - dried bone allograft, intrabony defect, periodontitis.
Brief summary
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.
Detailed description
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.
Interventions
OTHERPRP combined with DFDBA
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
OTHERDFDBA
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
Sponsors
Government Dental College and Hospital, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
28 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients * with chronic periodontitis * who were free of local or systemic disease * who had not received any type of periodontal therapy in the last six months * radiograph showing at least one angular defect in any quadrant * the involved teeth were vital and asymptomatic * the site of interest had at least 2 mm of keratinized gingiva on the facial aspect of the selected teeth
Exclusion criteria
* Patients with abnormal platelet count * allergic to chlorhexidine or any other medicine used in the study * showing unacceptable oral hygiene compliance during / after the phase I therapy; * pregnant or lactating mothers; * smokers * endodontically involved teeth * patients under any medication known to interfere with periodontal healing. e.g., corticosteroids * on anticoagulant therapy * patients with transferable jobs or who were uncooperative * patients participating in other dental clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Defect resolution from baseline to 12 months | 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 |
| Change in Crestal bone resorption from baseline to 12 months | 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 |
| Change in Defect fill from baseline to 12 months | 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 |
| Change in Probing Pocket Depth (PPD) from baseline to 12 months | 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. |
| Change in Periodontal Attachment Level (PAL) from baseline to 12 months | 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 |
| Change in Gingival Recession (GR) from baseline to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index | baseline to 12 months | Loe and Silness, 1963 |
| Plaque Index | baseline to 12 months | Silness and Loe, 1964 |
Countries
India
Outcome results
None listed