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Intrabony Periodontal DefectNCT03900013

Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

A study testing Injectable platelet rich fibrin combined with DFDBA and Demineralized Freeze Dried Bone Allograft in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients. Read more about this study

Who is it for?
Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Intrabony Periodontal Defect
What is being tested?
Injectable platelet rich fibrin combined with DFDBA and Demineralized Freeze Dried Bone Allograft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
20 Sep 2019to 20 Dec 2021
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 25 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Type III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level ≥ 5 mm and pocket depth ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Vital teeth
  • Non-smokers.
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • No periodontal therapy carried out in the past 6 months.
Show all 10Show fewer
  • Able to sign an informed consent form.
  • Patients age between 25 and 50 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index

Who cannot join

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry Cairo University

    Cairo, 12613

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.

Read the detailed description

Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Being tested
Injectable platelet rich fibrin combined with DFDBA, Demineralized Freeze Dried Bone Allograft
Keywords
Injectable platelet rich fibrin, I-PRF, Demineralized Freeze-Dried Bone Allograft, DFDBA, Stage 3 periodontitis, 3 wall intraosseous defect, 2 wall intraosseous defect
Medical subject headings
Periodontitis

What participants receive

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

  • Injectable platelet rich fibrin combined with DFDBAProcedure or surgery

    The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect

  • Demineralized Freeze Dried Bone AllograftProcedure or surgery

    Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect

Study groups in NCT03900013
Study groupRoleWhat they receive
Injectable Platelet Rich Fibrin (i-PRF) with DFDBAExperimentalIn i-PRF assigned group, 10 cc of blood per intraosseous defect will be collected right after administering the anaesthesia and will be processed according to the technique proposed by Choukroun et al., 2017 (centrifuged at 700 rpm, for 2-3 minutes). The yellow part will be collected using a syringe and added to a cup that contains the bone grafting material. The i-PRF consolidated bone graft will placed into the intraosseous defect.
Receives: Procedure: Injectable platelet rich fibrin combined with DFDBA
Demineralized Freeze-Dried Bone Allograft (DFDBA) aloneActive comparatorAfter debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling.
Receives: Procedure: Demineralized Freeze Dried Bone Allograft

What is being measured

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

  1. Clinical attachment level gain (CAL)

    CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

    Measured: CAL will be measured at base line, 3, 6, and 9 months postoperative

Secondary outcomes (4)

  1. Probing Depth (PD)

    PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

    Measured: PD will be measured at base line, 3, 6, and 9 months postoperative

  2. Radiographic defect fill (IBD)

    The depth of intrabony defect will be measured from the alveolar bone crest to the base of the defect at baseline, six months and after nine months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiograph. Radiographs will be scanned and the radiographic defect fill depth will be measured by a computer-aided software program

    Measured: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

  3. Gingival Recession Depth (RD)

    RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.

    Measured: RD will be measured at base line, 3, 6, and 9 months postoperative

  4. Post-surgical patient satisfaction

    A 3-item questionnaire will be asked to the patients and shall use a 7-points answer scale. These items will be:

    Would you experience the same surgery another time? Would you advice others with the surgery? To what extent are you satisfied with the results? 7 points mean the best

    1 means the worst

    Measured: After 9 months postoperative

Timeline

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

  1. First posted2 Apr 2019
  2. Study start20 Sep 2019
  3. Primary completion20 Oct 2021 (estimated)
  4. Study completion20 Dec 2021 (estimated)

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
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900013
Sponsor's protocol ID
MASH2019
Status last verified
Feb 2021
First submitted
31 Mar 2019
Last updated
4 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.

    PubMed 27783851

  • Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

    PubMed 1058834

  • Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug;91(8):987-96. doi: 10.1302/0301-620X.91B8.22546.

    PubMed 19651823

  • Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, Stevens M, Romberg E. Histologic evaluation of new attachment apparatus formation in humans. Part III. J Periodontol. 1989 Dec;60(12):683-93. doi: 10.1902/jop.1989.60.12.683.

    PubMed 2614633

  • BRODMAN K, ERDMANN AJ Jr, LORGE I, GERSHENSON CP, WOLFF HG. The Cornell Medical Index-health questionnaire. IV. The recognition of emotional disturbances in a general hospital. J Clin Psychol. 1952 May;8(3):289-93. doi: 10.1002/1097-4679(195207)8:33.0.co;2-b. No abstract available.

    PubMed 12981181

  • Chang YC, Zhao JH. Effects of platelet-rich fibrin on human periodontal ligament fibroblasts and application for periodontal infrabony defects. Aust Dent J. 2011 Dec;56(4):365-71. doi: 10.1111/j.1834-7819.2011.01362.x. Epub 2011 Oct 13.

    PubMed 22126345

  • Chenchev IL, Ivanova VV, Neychev DZ, Cholakova RB. Application of Platelet-Rich Fibrin and Injectable Platelet-Rich Fibrin in Combination of Bone Substitute Material for Alveolar Ridge Augmentation - a Case Report. Folia Med (Plovdiv). 2017 Sep 1;59(3):362-366. doi: 10.1515/folmed-2017-0044.

    PubMed 28976904

  • Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.

    PubMed 21740371

Questions about this trial

What is this clinical trial studying?

A study testing Injectable platelet rich fibrin combined with DFDBA and Demineralized Freeze Dried Bone Allograft in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.

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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. 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 Egypt. 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?

Results are not available in the source record.

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?

Clinical attachment level gain (CAL) (time frame: CAL will be measured at base line, 3, 6, and 9 months postoperative). 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 NCT03900013, which also lists 8 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 4 Feb 2021.

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