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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

PRP combined with DFDBA

DFDBA

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring platelet - rich plasma, demineralized freeze - dried bone allograft, intrabony defect, periodontitis.

Eligibility Criteria

28 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

212, Department of Periodontology, Government Dental college and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP combined with DFDBA

DFDBA

Arm Description

Open flap debridement, followed by placement of PRP combined with DFDBA

Open flap debridement, followed by placement of DFDBA

Outcomes

Primary Outcome Measures

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.

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

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

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

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

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

Secondary Outcome Measures

Plaque Index

Silness and Loe, 1964

Gingival Index

Loe and Silness, 1963

Full Information

NCT ID

NCT05886699

First Posted

March 2, 2015

Last Updated

May 23, 2023

Sponsor

Government Dental College and Hospital, India

1. Study Identification

Unique Protocol Identification Number

NCT05886699

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Government Dental College and Hospital, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

platelet - rich plasma, demineralized freeze - dried bone allograft, intrabony defect, periodontitis.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRP combined with DFDBA

Arm Type

Experimental

Arm Description

Open flap debridement, followed by placement of PRP combined with DFDBA

Arm Title

DFDBA

Arm Type

Active Comparator

Arm Description

Open flap debridement, followed by placement of DFDBA

Intervention Type

Other

Intervention Name(s)

PRP combined with DFDBA

Intervention Description

Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

Intervention Type

Other

Intervention Name(s)

DFDBA

Intervention Description

Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

Primary Outcome Measure Information:

Title

Change in Probing Pocket Depth (PPD) from baseline to 12 months

Description

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

Title

Change in Periodontal Attachment Level (PAL) from baseline to 12 months

Description

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

Title

Change in Gingival Recession (GR) from baseline to 12 months

Description

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

Title

Change in Crestal bone resorption from baseline to 12 months

Description

Time Frame

baseline to 12 months

Title

Change in Defect fill from baseline to 12 months

Description

Time Frame

baseline to 12 months

Title

Change in Defect resolution from baseline to 12 months

Description

Time Frame

baseline to 12 months

Secondary Outcome Measure Information:

Title

Plaque Index

Description

Silness and Loe, 1964

Time Frame

baseline to 12 months

Title

Gingival Index

Description

Loe and Silness, 1963

Time Frame

baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pallavi A Meshram, MDS

Organizational Affiliation

Government Dental College and Hospital, Nagpur, India

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ramreddy K Yeltiwar, MDS

Organizational Affiliation

Rungta College of Dental Sciences and Research, Bhilai, India.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mangesh B Phadnaik, MDS

Organizational Affiliation

Government Dental College and Hospital, Nagpur, India

Official's Role

Study Director

Facility Information:

Facility Name

212, Department of Periodontology, Government Dental college and Hospital

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440003

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All collected Individual Participant Data

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

to other researchers

Citations:

PubMed Identifier

16298220

Citation

Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.

Results Reference

background

PubMed Identifier

16686925

Citation

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.

Results Reference

background

PubMed Identifier

6759628

Citation

Quintero G, Mellonig JT, Gambill VM, Pelleu GB Jr. A six-month clinical evaluation of decalcified freeze-dried bone allografts in periodontal osseous defects. J Periodontol. 1982 Dec;53(12):726-30. doi: 10.1902/jop.1982.53.12.726.

Results Reference

background

PubMed Identifier

2693682

Citation

Rummelhart JM, Mellonig JT, Gray JL, Towle HJ. A comparison of freeze-dried bone allograft and demineralized freeze-dried bone allograft in human periodontal osseous defects. J Periodontol. 1989 Dec;60(12):655-63. doi: 10.1902/jop.1989.60.12.655.

Results Reference

background

PubMed Identifier

16838195

Citation

Gajiwala AL, Kumar BD, Chokhani P. Evaluation of demineralised, freeze-dried, irradiated bone allografts in the treatment of osseous defects in the oral cavity. Cell Tissue Bank. 2007;8(1):23-30. doi: 10.1007/s10561-006-9014-z.

Results Reference

background

PubMed Identifier

1391415

Citation

Mellonig JT. Autogenous and allogeneic bone grafts in periodontal therapy. Crit Rev Oral Biol Med. 1992;3(4):333-52. doi: 10.1177/10454411920030040201.

Results Reference

background

PubMed Identifier

9638695

Citation

Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.

Results Reference

background

PubMed Identifier

17635247

Citation

Demir B, Sengun D, Berberoglu A. Clinical evaluation of platelet-rich plasma and bioactive glass in the treatment of intra-bony defects. J Clin Periodontol. 2007 Aug;34(8):709-15. doi: 10.1111/j.1600-051X.2007.01108.x.

Results Reference

background

PubMed Identifier

12200975

Citation

Camargo PM, Lekovic V, Weinlaender M, Vasilic N, Madzarevic M, Kenney EB. Platelet-rich plasma and bovine porous bone mineral combined with guided tissue regeneration in the treatment of intrabony defects in humans. J Periodontal Res. 2002 Aug;37(4):300-6. doi: 10.1034/j.1600-0765.2002.01001.x.

Results Reference

background

PubMed Identifier

11895286

Citation

Lekovic V, Camargo PM, Weinlaender M, Vasilic N, Kenney EB. Comparison of platelet-rich plasma, bovine porous bone mineral, and guided tissue regeneration versus platelet-rich plasma and bovine porous bone mineral in the treatment of intrabony defects: a reentry study. J Periodontol. 2002 Feb;73(2):198-205. doi: 10.1902/jop.2002.73.2.198.

Results Reference

background

PubMed Identifier

11203586

Citation

de Obarrio JJ, Arauz-Dutari JI, Chamberlain TM, Croston A. The use of autologous growth factors in periodontal surgical therapy: platelet gel biotechnology--case reports. Int J Periodontics Restorative Dent. 2000 Oct;20(5):486-97.

Results Reference

background

PubMed Identifier

18454658

Citation

Piemontese M, Aspriello SD, Rubini C, Ferrante L, Procaccini M. Treatment of periodontal intrabony defects with demineralized freeze-dried bone allograft in combination with platelet-rich plasma: a comparative clinical trial. J Periodontol. 2008 May;79(5):802-10. doi: 10.1902/jop.2008.070436.

Results Reference

background

PubMed Identifier

10863370

Citation

Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.

Results Reference

background

PubMed Identifier

5237684

Citation

Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

Results Reference

background

PubMed Identifier

19228091

Citation

Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.

Results Reference

background

PubMed Identifier

15732870

Citation

Hanna R, Trejo PM, Weltman RL. Treatment of intrabony defects with bovine-derived xenograft alone and in combination with platelet-rich plasma: a randomized clinical trial. J Periodontol. 2004 Dec;75(12):1668-77. doi: 10.1902/jop.2004.75.12.1668.

Results Reference

background

PubMed Identifier

12516826

Citation

Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.

Results Reference

background

PubMed Identifier

21513477

Citation

Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.

Results Reference

background

PubMed Identifier

16634957

Citation

Linares A, Cortellini P, Lang NP, Suvan J, Tonetti MS; European Research Group on Periodontology (ErgoPerio). Guided tissue regeneration/deproteinized bovine bone mineral or papilla preservation flaps alone for treatment of intrabony defects. II: radiographic predictors and outcomes. J Clin Periodontol. 2006 May;33(5):351-8. doi: 10.1111/j.1600-051X.2006.00911.x.

Results Reference

background

PubMed Identifier

10815597

Citation

Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999 Dec;19(6):589-99.

Results Reference

background

PubMed Identifier

15736778

Citation

Camargo PM, Lekovic V, Weinlaender M, Vasilic N, Madzarevic M, Kenney EB. A reentry study on the use of bovine porous bone mineral, GTR, and platelet-rich plasma in the regenerative treatment of intrabony defects in humans. Int J Periodontics Restorative Dent. 2005 Feb;25(1):49-59.

Results Reference

background

PubMed Identifier

15948682

Citation

Okuda K, Tai H, Tanabe K, Suzuki H, Sato T, Kawase T, Saito Y, Wolff LF, Yoshiex H. Platelet-rich plasma combined with a porous hydroxyapatite graft for the treatment of intrabony periodontal defects in humans: a comparative controlled clinical study. J Periodontol. 2005 Jun;76(6):890-8. doi: 10.1902/jop.2005.76.6.890.

Results Reference

background

PubMed Identifier

17092242

Citation

Christgau M, Moder D, Wagner J, Glassl M, Hiller KA, Wenzel A, Schmalz G. Influence of autologous platelet concentrate on healing in intra-bony defects following guided tissue regeneration therapy: a randomized prospective clinical split-mouth study. J Clin Periodontol. 2006 Dec;33(12):908-21. doi: 10.1111/j.1600-051X.2006.00999.x.

Results Reference

background

PubMed Identifier

17257158

Citation

Dori F, Huszar T, Nikolidakis D, Arweiler NB, Gera I, Sculean A. Effect of platelet-rich plasma on the healing of intra-bony defects treated with a natural bone mineral and a collagen membrane. J Clin Periodontol. 2007 Mar;34(3):254-61. doi: 10.1111/j.1600-051X.2006.01044.x. Epub 2007 Jan 25.

Results Reference

background

PubMed Identifier

12886996

Citation

Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. doi: 10.1902/jop.2003.74.6.849.

Results Reference

background

PubMed Identifier

15898937

Citation

Kawase T, Okuda K, Saito Y, Yoshie H. In vitro evidence that the biological effects of platelet-rich plasma on periodontal ligament cells is not mediated solely by constituent transforming-growth factor-beta or platelet-derived growth factor. J Periodontol. 2005 May;76(5):760-7. doi: 10.1902/jop.2005.76.5.760.

Results Reference

background

PubMed Identifier

9371122

Citation

Whitman DH, Berry RL, Green DM. Platelet gel: an autologous alternative to fibrin glue with applications in oral and maxillofacial surgery. J Oral Maxillofac Surg. 1997 Nov;55(11):1294-9. doi: 10.1016/s0278-2391(97)90187-7.

Results Reference

background

PubMed Identifier

15085519

Citation

Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.

Results Reference

background

PubMed Identifier

2242423

Citation

Zehnder JL, Leung LL. Development of antibodies to thrombin and factor V with recurrent bleeding in a patient exposed to topical bovine thrombin. Blood. 1990 Nov 15;76(10):2011-6.

Results Reference

background

PubMed Identifier

1728869

Citation

Rapaport SI, Zivelin A, Minow RA, Hunter CS, Donnelly K. Clinical significance of antibodies to bovine and human thrombin and factor V after surgical use of bovine thrombin. Am J Clin Pathol. 1992 Jan;97(1):84-91. doi: 10.1093/ajcp/97.1.84.

Results Reference

background

PubMed Identifier

6396269

Citation

Mellonig JT. Decalcified freeze-dried bone allograft as an implant material in human periodontal defects. Int J Periodontics Restorative Dent. 1984;4(6):40-55. No abstract available.

Results Reference

background

PubMed Identifier

8354729

Citation

Guillemin MR, Mellonig JT, Brunsvold MA. Healing in periodontal defects treated by decalcified freeze-dried bone allografts in combination with ePTFE membranes (I). Clinical and scanning electron microscope analysis. J Clin Periodontol. 1993 Aug;20(7):528-36. doi: 10.1111/j.1600-051x.1993.tb00402.x.

Results Reference

background

PubMed Identifier

11453248

Citation

Committee on Research, Science and Therapy of the American Academy of Periodontology.. Tissue banking of bone allografts used in periodontal regeneration. J Periodontol. 2001 Jun;72(6):834-8. doi: 10.1902/jop.2001.72.6.834.

Results Reference

background

PubMed Identifier

11922217

Citation

Froum SJ, Wallace SS, Tarnow DP, Cho SC. Effect of platelet-rich plasma on bone growth and osseointegration in human maxillary sinus grafts: three bilateral case reports. Int J Periodontics Restorative Dent. 2002 Feb;22(1):45-53.

Results Reference

background

PubMed Identifier

15008930

Citation

Wiltfang J, Kloss FR, Kessler P, Nkenke E, Schultze-Mosgau S, Zimmermann R, Schlegel KA. Effects of platelet-rich plasma on bone healing in combination with autogenous bone and bone substitutes in critical-size defects. An animal experiment. Clin Oral Implants Res. 2004 Apr;15(2):187-93. doi: 10.1111/j.1600-0501.2004.00980.x.

Results Reference

background

PubMed Identifier

15777336

Citation

Aghaloo TL, Moy PK, Freymiller EG. Evaluation of platelet-rich plasma in combination with freeze-dried bone in the rabbit cranium. A pilot study. Clin Oral Implants Res. 2005 Apr;16(2):250-7. doi: 10.1111/j.1600-0501.2004.01075.x.

Results Reference

background

PubMed Identifier

16253084

Citation

Sanchez AR, Sheridan PJ, Eckert SE, Weaver AL. Regenerative potential of platelet-rich plasma added to xenogenic bone grafts in peri-implant defects: a histomorphometric analysis in dogs. J Periodontol. 2005 Oct;76(10):1637-44. doi: 10.1902/jop.2005.76.10.1637.

Results Reference

background

PubMed Identifier

16053853

Citation

Choi BH, Zhu SJ, Kim BY, Huh JY, Lee SH, Jung JH. Effect of platelet-rich plasma (PRP) concentration on the viability and proliferation of alveolar bone cells: an in vitro study. Int J Oral Maxillofac Surg. 2005 Jun;34(4):420-4. doi: 10.1016/j.ijom.2004.10.018. Epub 2005 Jan 27.

Results Reference

background

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

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