NCT02982681

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

December 1, 2016

Last Update Submit

December 1, 2016

Conditions

Periodontal DiseasesBone Resorption

Keywords

Periodontal diseasePlatelet rich fibrin

Outcome Measures

Primary Outcomes (1)

  • Intrabony defect fill

    change in intrabony defect fill from baseline to 9 months

    baseline to 9 months

Secondary Outcomes (3)

  • Probing depth

    baseline to 9 months

  • Clinical attachment level

    baseline to 9 months

  • Gingival Index

    baseline to 9 months

Study Arms (2)

Platelet rich Fibrin

EXPERIMENTAL

The 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.

Drug: Platelet rich fibrin

Bioactive glass

ACTIVE COMPARATOR

The 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

Drug: Bioactive Glass

Interventions

Platelet rich fibrinDRUG

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

Also known as: PRF
Platelet rich Fibrin
Bioactive GlassDRUG

The control site were packed with the bioactive glass graft alone

Also known as: Novabone
Bioactive glass

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10368057BACKGROUND

  • 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.

    PMID: 19089687BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesBone Resorption

Interventions

Bioglass

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12