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AzTrials

Periodontal DiseasesPhase 3NCT02982681

Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects

A Phase 3 study testing Platelet rich fibrin and Bioactive Glass in people with Periodontal Diseases and Bone Resorption, run by Dr. D. Y. Patil Dental College & Hospital.

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

Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be effective in promoting reduction in probing depth, gain in clinical attachment, and defect fill in intrabony periodontal defects. The individual role played by bioactive glass putty in combination with PRF is yet to be elucidated. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Periodontal Diseases, Bone Resorption
What is being tested?
Platelet rich fibrin and Bioactive Glass
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Apr 2015to Aug 2016
Phase
Phase 3
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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects.

Who cannot join

  • Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.

About this study

Official title: COMPARATIVE EVALUATION OF BIOACTIVE GLASS PUTTY AND PLATELET RICH FIBRIN IN THE TREATMENT OF HUMAN PERIODONTAL INTRABONY DEFECTS- A CLINICAL AND RADIOGRAPHICAL STUDY"

Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be effective in promoting reduction in probing depth, gain in clinical attachment, and defect fill in intrabony periodontal defects. The individual role played by bioactive glass putty in combination with PRF is yet to be elucidated.

AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects in humans.

Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on other side. The primary outcomes of the study included changes in probing depth, attachment level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3, 6, and 9 months. Radiographic assessment was done using standardized intra oral periapical radiographs. Comparisions were made within each group between baseline, 3 months, 6 months and 9 months using the ANOVA test followed by Bonferroni test.

Read the detailed description

INTRODUCTION

Periodontitis is an infectious disease that causes destruction of the attachment apparatus.[1].The mainstay aim of periodontal treatment is the regeneration of the lost attachment apparatus of the teeth. Variety of treatment modalities are available for periodontal regenerative therapy including bone grafts, bone substitutes, Guided Tissue Regeneration, growth factors, application of tissue engineering or the combination of two or more of the above listed approaches. [2] Alloplasts, may be an effective alternative to allograft and xenografts as there is no risk of disease transmission and the supply is unlimited.[3] The Bioactive glass promotes osteogenesis by adsorption and concentrations of protein utilized by osteoblast to form a mineralized extracellular matrix. [4] The advantage of the putty form of bioactive glass is the glycerine and polyethylene glycol which makes the glass particle coherent and thus enhancing handling characteristics and minimal migration of graft particles from the defect site. [5] Histological evaluation of material has shown that the particulate tends to retard the down growth of epithelial tissue. [6,7,8,9] Growth factors play a pivotal role in periodontal regeneration. Platelet Rich Fibrin is believed to release polypeptide growth factors, such as transforming growth factors-ß, platelet derived growth factors, vascular endothelial growth factors and matrix glycoproteins (such as thrombospondin -1) into the surgical wound in a sustained fashion for at least 7 days as shown in vitro. [10] Thus, given the unique graft with osteoconductive, osteoinductive and osteostimulative properties and properties of autologous PRF, application of combination approach was attempted for the assessment of their additional benefits to the healing mechanisms and periodontal regeneration in intrabony defects.

Materials and methods Patient Selection This randomized control trial was carried out in the Department of Periodontics and Oral Implantology, Santosh Dental College and Hospital, Santosh University, Ghaziabad. Ten patients suffering chronic localized periodontitis aged between 20 -50 years (7 males and 3 females) with 10 pairs of contalateral intraosseous defects (n=20) comprised the study population. A total of 20 bone defects (10 pairs) were decided by the statisticion to be of statistical strength. Convenient sampling design was used for the enrolment of study patients. Ethical approval was taken from the institutional ethical committee The patients were explained in detail about the procedure and a written informed consent was taken. The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects. [3] Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.

PRESURGICAL THERAPY Patients underwent phase I therapy. The selected defects were evaluated after 2 weeks, and persistent pockets > or = 5mm and patients with clinical radiographic evidence of angular osseous defects were scheduled for surgery.

Clinical Parameters :

Oral hygiene status was recorded using the gingival index of Loe \& Sillness,[11];

with score 0 indicating absence of inflammation and score 3 indicating severe

inflammation and plaque index of Silness \& Loe. [12]

Probing pocket depth and Clinical attachment level were recorded at baseline on the

day of surgery, 3, 6 and 9 months intervals using UNC-15 probe and customized

acrylic occlusal stents grooved in the area of defect to provide reproducible insertion

axis-

The following measurements were recorded with customized

acrylic stent:

  • Fixed reference point (FRP) to the base of pocket (BP)
  • Fixed reference point (FRP) to the cemento-enamel junction (CEJ)
  • Fixed reference point (FRP) to the gingival margin (GM)

PPD and CAL were calculated from these probing measurements as:

  • PPD = (FRP to BP) - (FRP to GM)
  • CAL= (FRP to BP) - (FRP to CEJ)

Radiographic measurements: Standardized intra-oral periapical radiographs of the defects were taken using a paralleling technique.[13]

Amount of defect fill: Defects were measured from the fixed reference point (distance between the cemento-enamel junction to the radiographic base of the bone defect ) with the help of 1.1 mm grid and the following radiographic features were recorded on the day of surgery, 3, 6 and 9 months intervals.

Being tested
Platelet rich fibrin, Bioactive Glass
Keywords
Periodontal disease, Platelet rich fibrin
Medical subject headings
Periodontal Diseases, Bone Resorption

What participants receive

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

  • Platelet rich fibrinDrug

    Also called PRF

    In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site

  • Bioactive GlassDrug

    Also called Novabone

    The control site were packed with the bioactive glass graft alone

Study groups in NCT02982681
Study groupRoleWhat they receive
Platelet rich FibrinExperimentalThe intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.
Receives: Drug: Platelet rich fibrin
Bioactive glassActive comparatorThe intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone
Receives: Drug: Bioactive Glass

What is being measured

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

  1. Intrabony defect fill

    change in intrabony defect fill from baseline to 9 months

    Measured: baseline to 9 months

Secondary outcomes (3)
  1. Probing depth

    change in probing depth from baseline to 9 months

    Measured: baseline to 9 months

  2. Clinical attachment level

    change in Clinical attachment level from baseline to 9 months

    Measured: baseline to 9 months

  3. Gingival Index

    change in Gingival Index from baseline to 9 months

    Measured: baseline to 9 months

Timeline

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

  1. First posted5 Dec 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982681
Sponsor's protocol ID
SUG/25/2015
Status last verified
Dec 2016
First submitted
1 Dec 2016
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Hall EE, Meffert RM, Hermann JS, Mellonig JT, Cochran DL. Comparison of bioactive glass to demineralized freeze-dried bone allograft in the treatment of intrabony defects around implants in the canine mandible. J Periodontol. 1999 May;70(5):526-35. doi: 10.1902/jop.1999.70.5.526.

    PubMed 10368057
  • Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.

    PubMed 19089687

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Platelet rich fibrin and Bioactive Glass in people with Periodontal Diseases and Bone Resorption, run by Dr. D. Y. Patil Dental College & Hospital.

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 1 inclusion and 1 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Intrabony defect fill (time frame: baseline to 9 months). 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 NCT02982681, which also lists 2 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 5 Dec 2016.

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