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Regeneration of Human Intrabony Defects With rhFGF-2/HA

NCT02337166 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-13

No results posted yet for this study

Summary

BACKGROUND: Periodontal disease is an infection that results in progressive loss of dental support, which may lead to tooth loss.. The goal of the present study was to evaluate if recombinant human Fibroblast Growth Factor type 2 (rhFGF-2) applied in periodontal intrabony defects in a hyaluronic acid (HA) carrier would enhance the clinical paramenters of regeneration of the periodontal attachment apparatus and the long-term maintenance of the results obtained. METHODS: Thirty adult patients were evaluated. Initial treatment consisted in plaque control measures executed previously to the experimental phase. Two intra-bony defects in each patient were ramdomly allocated for each of the treatment methods employed. Control group (n=30) were treated by open debridement with the papilla preservation flaps, while the text group (n=30) also received a topical application of rhFGF-2/HA in the intrabony defect. The parameters evaluated were, probing depth (PD), gingival recession (REC), probing attachment level (PAL) and probing bone level (PBL). Clinical measurements obtained at baseline and 1, 5 and 10 years after the surgical procedure were compared.

Conditions

  • Periodontitis

Interventions

DEVICE

a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate

0.2ml of a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate MW 1.3 x 106

PROCEDURE

Periodontal flap surgery

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Ronaldo B Santana, DDS,MScD,DSc · Federal Fluminense University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02337166 on ClinicalTrials.gov