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Regeneration of Human Intrabony Defects With rhFGF-2/HA

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ClinicalTrials.gov Identifier: NCT02337166
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Universidade Federal Fluminense

Brief 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.

Condition or disease Intervention/treatment Phase
Periodontitis Device: a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate Procedure: Periodontal flap surgery Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regeneration of Human Intrabony Defects With Recombinant Human Fibroblast Growth Factor 2 in a Hyaluronic Acid Gel Carrier - a Longitudinal, Prospective, Randomized Controlled Clinical Trial
Study Start Date : December 2002
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arm Intervention/treatment
Active Comparator: Control
open instrumentation of the root surfaces and bone defects via flap modified papilla preservation flap
Procedure: Periodontal flap surgery
Experimental: Test
open instrumentation of the root surfaces and bone defects via flap modified papilla preservation flap and application of a rhFGF-2/HA in the intrabony defect
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




Primary Outcome Measures :
  1. Probing attachment level gain [ Time Frame: up to 10 years ]
  2. Bone level gain [ Time Frame: up to 10 years ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(a) adult subjects with chronic periodontitis presenting (b) radiographic evidence alveolar bone loss at the proximal aspect of the tooth, (c) intrabony defect deeper than 4mm, (d) probing pocket depth >6 mm at the site, (e) unremarkable general health according to medical history and clinical judgment, (f) no medications taken for at least six months and no antibiotics taken for twelve months before the beginning of the study.

Exclusion Criteria:

(a) subjects with "early onset" or aggressive forms of periodontitis, (b) current smokers, (c) presence of significant systemic diseases (i.e., cancer, AIDS, diabetes), (d) clinical evidence of furcation defects, (e) presence of apical radioleucency and (f) previous lack of cooperation with the maintenance program.


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337166


Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
Principal Investigator: Ronaldo B Santana, DDS,MScD,DSc Federal Fluminense University

Responsible Party: Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT02337166     History of Changes
Other Study ID Numbers: CEP-HUAM/CCM 21/03
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by Universidade Federal Fluminense:
alveolar bone loss
periodontal attachment loss

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents