NCT02692079

Brief Summary

This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

February 18, 2016

Last Update Submit

February 22, 2016

Conditions

Keywords

AngiogenesisBilateral infrabony defectFlap surgeryTitanium-prepared, platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

  • Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)

    Within the first 30 days after surgery

Secondary Outcomes (1)

  • The Volume of Gingival Crevicular Fluid (microliter)

    Within the first 30 days after surgery

Study Arms (2)

T-PRF+Allograft

EXPERIMENTAL

The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Test group sites were treated with T-PRF+allograft

Procedure: T-PRFProcedure: Allograft

Allograft

EXPERIMENTAL

The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Control group sites were treated with only allograft

Procedure: Allograft

Interventions

T-PRFPROCEDURE

Flap Surgery

T-PRF+Allograft
AllograftPROCEDURE

Flap Surgery

AllograftT-PRF+Allograft

Eligibility Criteria

Age26 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical Diagnosis of Chronic Periodontitis
  • The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy

You may not qualify if:

  • Systemic illnesses
  • Any medications known to affect the outcomes of periodontal surgery
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Corresponding author, Clinical Research

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 25, 2016

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share