Periodontal Diseases Clinical Trial
Official title:
Treatment of Periodontal Intrabony Defects With Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone. A Non-Inferiority Trial
The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the periodontium including a functional periodontal ligament, alveolar bone and cementum. A number of treatment modalities including the use of bone grafts, guided tissue regeneration (GTR), and the addition of biological agents have been used with large heterogeneity in the clinical and histological outcomes. The rationale of using a filling material when treating unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists of sustaining the overlying soft tissues in the presence of a non-contained defect's architecture, at the same time enhancing the stability of coagulum; and facilitating the proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years, the increasing understanding of the role of growth factors (GFs) in the wound healing process suggested the use of these biological agents in the regenerative treatment of periodontal bony defects. Noninferiority trials are designed to demonstrate that the effect of a new treatment is adequately similar to an active control by more than a specified margin The aim of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the management of IBDs may be a treatment modality that is clinically "not inferior" compared to the membrane + ABB one, since the combined periodontal regenerative technique has been already tested in literature as a "gold standard" periodontal regenerative technique.
Experimental Design This is a prospective, randomized and controlled clinical trial designed
to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities
of IBDs: test sites ( TS) will be treated by a combination of PRF and ABB; control sites (CS)
will receive the combined treatment of collagen membrane + ABB. The patients enrolled will
exhibit unfavorable IBDs and all experimental sites will be accessed with a simplified
papilla preservation flap (SPPF) procedure. The filling material (ABB) will be common to both
treatments: therefore, the investigation focused on the addictive effect of PRF used instead
of COLLAGEN MEMBRANE. Collagen membrane is chosen as the active control (AC) as it is
currently considered as the "gold standard" among the biological agents for the treatment of
IBDs.
A non-inferiority trial (NIT) is designed to verify whether to use PRF instead of collagen
membrane in association with ABB can lead to not inferior therapeutic results, reducing the
treatment's cost and allowing the clinicians to use autogenous materials only.
Study Population 62 patients (33 males and 29 females) aged 42 to 64 years (mean: 53±12)
seeking treatment at the Unit of Periodontology of the "G. D'Annunzio" University of Chieti-
Pescara, Italy, and affected by moderate-to-severe chronic periodontitis, will be selected
for the study. The inclusion criteria are: 1) no systemic diseases; 2) no medications
affecting periodontal status during the previous 6 months; 3) not pregnant or lactating; 4)
non-smoker; and 5) the following dental and periodontal factors: a full-mouth plaque score
(FMPS)25 and a full-mouth bleeding score (FMBS)26 < 20% at the time of surgery, no
periodontal therapy in the 2 previous years, no inadequate endodontic treatment at the
experimental sites, no dental mobility, ≥ 20 teeth, exhibit vertical bone loss detected by
radiographic examination ( ACL (alveolar crest level) - (BD bottom of the defect) distance =
BDD (Bone defect depth ) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12
weeks after non- surgical therapy [ scaling and root planing ( SRP)]. Only predominantly 1-,
combined 1- and 2-, 2-walls defects or teeth with a defect angle ≥ 36° were considered in
this study (unfavorable IBDs). To be included in this category, the IBDs should not have a
3-wall component >20% of the total defect depth. The architecture of the defect had to be
confirmed by observation during the surgical intervention. Each patient will participate in
the study with a single experimental site. In the case that a patient will have more than one
IBD with clinical features that could be eligible for study, the most severe defect will be
chosen. The participants volunteered for the study after they will receive verbal and written
information and signed a consent form approved by the Ethical Committee of the G. D'Annunzio
University of Chieti - medical faculty. The study protocol is in accordance with the
Declaration of Helsinki of 1975, revised in Tokyo in 2004. The study was performed from
February 2013 to December 2016. Four months before the surgical treatment, all 44 patients
will undergo SRP by ultrasonic instruments II and hand curettes¶ and motivational
instructions on oral home care.
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