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Chronic PeriodontitisNCT05886699

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

A study testing PRP combined with DFDBA and DFDBA in people with Chronic Periodontitis, run by Government Dental College and Hospital, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 to 55 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
PRP combined with DFDBA and DFDBA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteIndia
Study dates
Jan 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • 212, Department of Periodontology, Government Dental college and Hospital

    Nagpur, Maharashtra, 440003

Other trials in India

About this study

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

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.

Read the 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.

Being tested
PRP combined with DFDBA, DFDBA
Keywords
platelet - rich plasma, demineralized freeze - dried bone allograft, intrabony defect, periodontitis.
Medical subject headings
Chronic Periodontitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRP combined with DFDBAOther

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

  • DFDBAOther

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

Study groups in NCT05886699
Study groupRoleWhat they receive
PRP combined with DFDBAExperimentalOpen flap debridement, followed by placement of PRP combined with DFDBA
Receives: Other: PRP combined with DFDBA
DFDBAActive comparatorOpen flap debridement, followed by placement of DFDBA
Receives: Other: DFDBA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline to 12 months

  2. 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

    Measured: baseline to 12 months

  3. 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

    Measured: baseline to 12 months

  4. 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

    Measured: baseline to 12 months

  5. 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

    Measured: baseline to 12 months

  6. 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

    Measured: baseline to 12 months

Secondary outcomes (2)

  1. Plaque Index

    Silness and Loe, 1964

    Measured: baseline to 12 months

  2. Gingival Index

    Loe and Silness, 1963

    Measured: baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study startJan 2012
  3. Primary completionDec 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886699
Sponsor's protocol ID
PMeshram
Status last verified
May 2023
First submitted
2 Mar 2015
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected Individual Participant Data

Publications

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

    PubMed 16298220

  • 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.

    PubMed 16686925

  • 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.

    PubMed 6759628

  • 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.

    PubMed 2693682

  • 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.

    PubMed 16838195

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

    PubMed 1391415

  • 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.

    PubMed 9638695

  • 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.

    PubMed 17635247

  • 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.

    PubMed 12200975

  • 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.

    PubMed 11895286

  • 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.

    PubMed 11203586

  • 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.

    PubMed 18454658

  • 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.

    PubMed 10863370

  • 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.

    PubMed 5237684

  • 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.

    PubMed 19228091

Questions about this trial

What is this clinical trial studying?

A study testing PRP combined with DFDBA and DFDBA in people with Chronic Periodontitis, run by Government Dental College and Hospital, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Probing Pocket Depth (PPD) from baseline to 12 months (time frame: baseline to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886699, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

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