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Int Poster J Dent Oral Med 7 (2005), No. 3     15. Sep. 2005

Int Poster J Dent Oral Med 2005, Vol 7 No 03, Poster 284

Evaluation of the Polylactide-Polyglycolide Copolymer Fisiograft® in Treatment of Deep Intrabony Defects

Language: English

Authors:
Assist. Prof. Dr. Dr. Stefan-Ioan Stratul1, Dr. Darian Rusu1, Prof. Dr. Dr. Anton Sculean2
1Victor Babes University of Medicine and Pharmacy Timisoara, Romania
2Johannes Gutenberg University, Mainz, Germany

Date/Event/Venue:
DGP Jubilaeumstagung 2004 Dresden
9-11 September 2004
ICC Dresden
Germany

Introduction

Resorbable synthetic polymers have been developed by the biomedical research over the last decades. Among them, the Polylactic and the Polyglycolic acids and their copolymers under various proportions, were extensively used in manufacturing surgical devices destined to the oral, maxillo-facial and orthopaedic surgery (Pihlajamaki et al. 1998, Waris et al. 2003). Experimental studies have demonstrated that the degradation period of the commonly used polymeric surgical devices (osteosynthesis plates, screws, sutures or membranes) is correlated with local factors and with the specific density, which further depends on the polymerization degree/the molecular weight of the material (Heidemann et al. 2003). A low-density polylactide-polyglycolide copolymer (Fisiograft®, Ghimas S.p.A., Casalecchio di Reno, Italy) was recently used as a space filler in dentistry to treat closed bone defects and in implantology for sinus floor augmentations. The material is currently manufactured as gel, granules or sponge, displays a good handling during the surgery; degradation occurs through "bulk erosion" by hydrolysis in a period between 3-6 months, depending on the tissular conditions, leaving instead a high percentage of bone (Piatelli 2003). So far, there are no clinical studies to evaluate the effect of the polylactide-polyglycolide copolymer Fisograft® in the treatment of deep periodontal intrabony defects.


Objectives

Objective of this clinical controlled study was to compare clinically the treatment of deep intrabony defects using the combination of flap surgery (FS)+ polylactide-polyglycolide Fisiograft® to the FS alone.


Material and Methods

Thirteen patients (10 male and 3 female), between 33-57 years old, with moderate to severe periodontitis, light- or non-smokers, and displaying a total of 24 deep intrabony defects, were treated either with the combination of FS + Fisiograft® (test) or with FS alone (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. 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, without any grafting procedure. 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.


Results

The healing phase progressed uneventful. 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 GR (mm) GR CAL (mm) CAL gain (mm) CEJ BD BC BD CEJ BC
      Pre-operative After 6 months Diff. Pre-operative After 6 months Diff. Pre-operative After 6 months        
1 43 2 5 3 2 1 1 0 6 4 2 8 4 4
2 46 3 7 6 1 1 0 -1 8 6 2 10 4 6
3 33 2 7 3 4 0 0 0 7 3 4 8 6 2
4 36 1 7 4 3 0 0 0 7 4 3 8 5 3
5 48 2 10 5 5 0 1 1 10 6 4 11 8 3
6 46 2 9 3 6 1 3 2 10 6 4 11 8 3
7 17 1 9 4 5 1 2 1 10 6 4 11 6 5
8 14 1 8 3 5 0 1 1 8 4 4 9 7 2
9 17 1 7 4 3 0 0 0 7 4 3 8 6 2
10 11 1 6 2 4 2 6 4 8 8 0 9 4 5
11 17 c 12 6 6 0 3 3 12 9 3 16 9 7
12 46 1 8 3 5 2 3 1 10 6 4 10 6 4
Mean     7.92 3.83 4.08 0.67 1.67 1.00 8.58 5.50 3.08 9.92 6.08 3.83
SD     1.88 1.27 1.56 0.78 1.83 1.41 1.78 1.78 1.24 2.27 1.68 1.64
Tab. 1: Six months clinical results of treatment of intrabony defects with FS + Fisiograft®


Patient Nr. Tooth Type Defect Type (walls) PPD (mm) PPD GR (mm) GR CAL (mm) CAL gain (mm) CEJ BD BC BD CEJ BC
      Pre-operative After 6 months Diff. Pre-operative After 6 months Diff. Pre-operative After 6 months        
1 27 2 6 5 1 0 0 0 6 5 1 7 5 2
2 34 2 7 3 4 0 1 1 7 4 3 8 4 4
3 24 1 7 4 3 0 4 4 7 8 -1 8 5 3
4 16 1 6 3 3 2 6 4 8 9 -1 9 4 5
5 21 2 6 4 2 3 5 2 9 9 0 12 3 9
6 23 2 6 3 3 1 1 0 7 4 3 9 4 5
7 24 2 8 4 4 0 1 1 8 5 3 9 3 6
8 16 2 7 4 3 1 3 2 8 6 2 9 4 5
9 46 1 9 8 1 1 2 1 10 10 0 12 4 8
10 33 1 9 5 4 1 3 2 10 8 2 12 4 8
11 23 2 7 4 3 2 3 1 9 7 2 10 5 5
12 34 1 7 6 1 2 3 1 7 9 -2 8 4 4
Mean     7.08 4.42 2.67 1.08 2.67 1.58 8.00 7.00 1.00 9.42 4.08 5.33
SD     1.08 1.44 1.15 1.00 1.78 1.31 1.28 2.13 1.76 1.73 0.67 2.10
Tab. 2: Six months clinical results of treatment of intrabony defects with flap surgery (FS) alone

No differences in any of the investigated parameters were observed at baseline between groups. The clinical measurements six months after treatment revealed in the group of defects treated with the combination of FS + Fisiograft® (Table 1) a reduction of the probing pocket depth (PD) from 7.92 ± 1.88 mm to 3.83 ± 1.27 mm (p=0.002), and a change of the mean clinical attachment level (CAL) from 8.58 ± 1.78 mm to 5.50 ± 1.78 mm (p=0.003). In the control group, the mean PD was reduced from 7.08 ± 1.08 mm to 4.42 ± 1.44 (p=0.002) and the mean CAL changed from 8.00 ± 1.28 mm to 7.00 ± 2.13 (ns) (Table 2). The test treatment resulted in statistically higher PD reductions (p=0.024) and CAL gains (p=0.02) than the control group (Table 3). In both groups, a minute or no radiographic defect fill was observed at six months after treatment.


Treatment Baseline 6 months Difference Significance
Probing depth        
Fisiograft 7.92±1.88 3.83±1.27 4.08±1.56 p=0.002
Acces flap 7.08±1.08 4.42±1.44 2.67±1.15 p=0.002
    p<0.024  
Gingival recession        
Fisiograft 0.67±0.78 1.67±1.83 1.00±1.41 p=0.031
Acces flap 1.08±1.00 2.67±1.78 1.58±1.31 p=0.004
    n.s.  
Clinical
attachment level
       
Fisiograft 8.58±1.78 5.50±1.78 3.08±1.24 p=0.030
Acces flap 8.00±1.28 7.00±2.13 1.00±1.76 p=0.063
    p=0.002  
Tab. 3: Clinical parameters at baseline and 6 months for the Fisiograft
and the flap surgery groups (n=12 for each group)


Case A

Fig. 1a: The bone defect exposed Fig. 1b: Fisiograft® in place

Fig. 1c: Rx image before treatment Fig. 1d: Rx image at six months


Case B

Fig. 2a: The bone defect exposed Fig. 2b: Fisiograft® in place

Fig. 2c: Rx image before treatment Fig. 2d: Rx image at six months

Conclusion

  1. At six months after the surgery both therapies resulted in PD reductions and CAL gains.
  2. Treatment with flap surgery + Fisiograft® resulted in significantly higher CAL gains and PD reductions than treatment with FS alone.
  3. More controlled clinical studies are needed in order to evaluate the regenerative potential of the polylactide-polyglycolides, the most suitable delivery form of Fisiograft®, and its most effective combinations with other regenerative materials.

Abbreviations

PD - probing depth
CAL - clinical attachment level
GR - gingival recession


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
Romania