Comparison of PRP & DFDBA vs. DFDBA in Intrabony Periodontal Defects

Study Overview
=================
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.

Official Title
-----------------
Comparison of Efficacy of Autologous Platelet - Rich Plasma Combined With Demineralized Freeze - Dried Bone Allograft Versus Demineralized Freeze - Dried Bone Allograft: A Randomized Clinical Trial in Central India

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Other: PRP combined with DFDBA
* Other: DFDBA


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP combined with DFDBA<br>Open flap debridement, followed by placement of PRP combined with DFDBA | Other: PRP combined with DFDBA<br>* Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA<br>|
| Active Comparator: DFDBA<br>Open flap debridement, followed by placement of DFDBA | Other: DFDBA<br>* Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Silness and Loe, 1964 | baseline to 12 months | 
| Gingival Index | Loe and Silness, 1963 | baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet - rich plasma, demineralized freeze - dried bone allograft, intrabony defect, periodontitis.