Clinical Trial: Regeneration of Human Intrabony Defects With rhFGF-2/HA
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Study Population and Experimental Design The study was designed as a randomized, prospective, split-mouth, controlled clinical trial. It was conducted in accordance with the guidelines of the World Medical Association Declaration of Helsinki (version VI, 2002), after approval of the study design and consent by the Faculty of Medicine, Ethical Committee of Medical Research, Federal Fluminense University (Approval protocol CEP-HUAM/CCM 21/03). Written informed consent was obtained from all subjects. Systemically healthy patients with moderate to advanced chronic periodontitis referred to the Department of Periodontology, Faculty of Dentistry, Federal Fluminense University for periodontal treatment of advanced periodontitis were recruited for and treated in the study.
Inclusion criteria of the study were: (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. Subjects who have quit the habit of smoking for at least one year before the beginning of the study were considered as non-smokers and, if the other included criteria were met, were included in the present sample. Exclusion criteria for the study were: (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.
Two defects were selected
Sponsor: Universidade Federal Fluminense
Current Primary Outcome:
- Probing attachment level gain [ Time Frame: up to 10 years ]
- Bone level gain [ Time Frame: up to 10 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Universidade Federal Fluminense
Dates:
Date Received: January 8, 2015
Date Started: December 2002
Date Completion:
Last Updated: January 12, 2015
Last Verified: January 2015
