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International Poster Journal of Dentistry and Oral Medicine



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Int Poster J Dent Oral Med 9 (2007), No. 1     15. Mar. 2007

Int Poster J Dent Oral Med 2007, Vol 9 No 01, Poster 347

Clinical Comparison Between a Polylactide-polyglicolide Copolymer (Fisiograft®) and an Enamel Matrix Protein Derivative (Emdogain®) for the Treatment of Intrabony Periodontal Defects in Humans

Language: English

Assist. Prof. Dr. Dr. Stefan-Ioan Stratul, Victor Babes University of Medicine, Romania,
Dr. Darian Rusu, Dr. Adrian Bacila, Periodontal Clinic Dr. Stratul, Timisoara, Romania,
Dr. Anca Benta, Johannes Gutenberg University Mainz, Germany

14-15 May 2005
10th Congress of the Balkanic Society of Stomatology BaSS
Belgrade, Republic of Serbia


Polylactides and polyglicolides are known from their pharmaceutical (retard medication supports), surgical (resorbable sutures, screws, microplates, membranes, sinus lift procedures etc.) and TE (bioresorbable supports for cultured cells) applications A polylactide-polyglicolide copolymer (PLA-PGL) has been documented clinically to enhance bone regeneration in closed bone defects (Bucci et al.1999, Piatelli et al. 2000, Piatelli 2003, Serino et al. 2003, Rimondini et al.2005) and to sustain periodontal healing in intrabony defects (Stratul et al. 2004). So far, there are no controlled clinical studies to compare the effect of the PLA-PGL with the effect of other "biological agents" in treating deep intrabony defects.


Aim of this clinical controlled study was to compare the treatment of deep intrabony defects with the PLA-PGL copolymer Fisiograft® (Ghimas s.p.a., Casalecchio di Reno, Italy) to the enamel-matrix-protein-derivative EMD Emdogain® (Straumann AG, Waldenburg, Switzerland).

Material and Methods

Nineteen patients (11 male and 8 female), between 32-61 years old, with moderate to severe periodontitis, light- or non-smokers, and displaying a total of 26 deep intrabony defects, were treated either with the combination of flap surgery + Fisiograft® (test) or with FS + EMD (control). All patients underwent initial therapy one month prior to surgery. All patients were instructed and motivated to maintain a good oral hygiene level, verified by a reduction of the PI (Silness and Löe) < 1. Before surgery and six months after, the following clinical parameters were registrated: the periodontal pocket depth (PD), the gingival recession (GR) and the clinical attachment level (CAL). All measurements were performed with a rigid periodontal probe (PCP 12, Hu-Friedy), at six sites per tooth (buccal: mesiobuccal, central, distobuccal; oral: mesiooral, central, distooral). Radiographic examination was performed using the conventional RIO technique. For each patient, the highest measured value was taken into account and the mean PD, GR and CAL were calculated. The Wilcoxon paired-samples test was used to compare the differences between baseline values and the values measured six months after and the Mann-Whitney U independent-samples test was used for comparison between the groups. The alpha-error was set 0.05, and the power of the study 0.57. Surgery was performed under local anesthesia. A full thickness flap was raised after intrasulcular incision, without using release incisions. After removal of the granulation tissue, the exposed roots underwent thorough S/RP, using ultrasonic devices and curettes. No resective surgery was performed, nor any root conditioning. Fisiograft® was placed into the defects of the test group. Application form of the product (gel, granules, sponge, gel+granules) was randomly assigned to each defect.The amount of material did not exceed the margins of the defect. The defects of the control group underwent the same surgical protocol, except they were filled with Emdogain® gel. Post surgical care included antibiotherapy for one week (3x500 mg Amoxycilin daily) and 0.2% Chlorhexidin (Dentaton®, Ghimas s.p.a., Casalecchio di Reno, Italy) mouth rinses, twice a day, for the following two weeks, as gentle debridement of the operated area every second week, during two months.


No adverse healing response was observed. No signs of inflammation, infection, allergy or severe pain were present. Pre- and postoperative mean values of the PD, GR and CAL in the two treated groups are displayed in the table No.1 and table No.2.

Patient Nr. Tooth Type Defect Type(walls) PPD (mm) PPD CAL (mm) CAL gain(mm) GR (mm) GR CEJ BD BC BD CEJ BC
   Pre-operativeAfter 6 monthsDiff.Pre-operativeAfter 6 months Pre-operativeAfter 6 monthsDiff.   
Mean  7,773,384,389,084,774,311,311,380,0810,086,233,85
SD  1,480,771,393,571,093,612,721,262,813,302,201,95
Table 1. Six months clinical results of treatment of intrabony defects with Fisiograft®

Patient Nr. Tooth Type Defect Type(walls) PPD (mm) PPD CAL (mm) CAL gain(mm) GR (mm) GR CEJ BD BC BD CEJ BC
   Pre-operativeAfter 6 monthsDiff.Pre-operativeAfter 6 months Pre-operativeAfter 6 monthsDiff.   
Mean  7,543,853,698,155,852,310,622,001,389,926,083,85
SD  1,201,281,551,141,281,320,771,411,661,121,711,34
Table 2. Six months clinical results of treatment of intrabony defects with Emdogain®

No differences in any of the investigated parameters were observed at baseline between groups (Table 3). Six months after the treatment, the sites treated with PLA-PGL showed a reduction in probing pocket depth(PPD) from 7.77±1.48mm to 3.38±0.77mm (p=0.001) and a change in clinical attachment level(CAL) from 9.08±3.57mm to 4.77±1.09mm (n.s.). In the group treated with EMD, PPD was reduced from 7.54±1.20mm to 3.85±1.28mm (p=0.001), CAL changed from 8.15±1.14mm to 5.85±1.28mm (p=0.016) (Table 4). No or little hard tissue fill was observed radiographically in the defects treated with PLA-PGL.

Treatment CAL (mm) CEJ-BD (mm) CEJ-BC (mm) INTRA (mm)
EMD (n=13)5,85±1,289,92±1,123,85±1,346,08±1,71
Fisio (n=13)4,77±1,0910,08±3,303,85±1,956,23±2,20
Table 3 Intraoperative measurements for the Fisiograft(R) and Emdogain(R) groups

TreatmentBaseline6 monthsDifferenceSignificance
Probing depth
Gingival recession
Clinical attachment level
Table 4. Clinical parameters at baseline and 6 months for the EMD (n=13) and the fisio surgery groups (n=13)

Fig.1 Case A a) The bone defect exposed Fig.1 Case A b) Fisiograft® in place
Fig.1 Case A c) Rx image before treatment Fig.1 Case A d) Rx image at six months

Fig.2 Case B a) The bone defect exposed Fig.2 Case B b) Emdogain ® in place
Fig.2 Case B c) Rx image before treatment Fig.2 Case B d) Rx image at six months


Both treatments resulted in improvements of PPD and CAL. A statistically significant difference between the groups in favor of Fisiograft® group was observed with respect to CAL gain(p=0.029), no statistically significant PPD reduction difference between groups in favor of Fisiograft® was observed. At six months, both therapies seemed to lead to significant improvements of the investigated clinical parameters.


PLA-PGL: polylactide-polyglicolide
EMD: enamel-matrix-protein-derivative
PPD: probing pocket depth
CAL: clinical attachment level
GR: gingival recession
TE: tissue engineering
PlI: plaque index
GI: gingival index
BOP: bleeding on probing

This Poster was submitted by Assist. Prof. Dr. Dr. Stefan-Ioan Stratul.

Correspondence address:
Assist. Prof. Dr. Dr. Stefan-Ioan Stratul
Str.Em.Gojdu, no.5
300176 Timisoara