Int Poster J Dent Oral Med 2005, Vol 7 No 03, Poster 286
Non-surgical periodontal therapy using a novel chlorhexidine-based xanthan-gel: a split-mouth study
Language: English
Authors:
Dr. Darian Rusu1, Assist. Prof. Dr. Dr. Stefan-Ioan Stratul1, Dr. Alin Necker1, Dr. Anca Benta2
1Victor Babes University of Medicine and Pharmacy Timisoara, Romania
2Johannes Gutenberg University, Mainz, Germany
Date/Event/Venue:
Joint Meeting of the Continental European Division (CED),
Scandinavian Division (NOF) and Israeli Division (ID) of IADR
25-28 August 2004
Istanbul, Turkey
Introduction
Topical subgingival antimicrobials have been successfully evaluated in split-mouth clinical trials (Stelzel & Flores-de-Jacoby 1992, Berglundh et al. 1998, Eickholz et al. 2002). The adjunctive use of antimicrobial agents to non-surgical therapy seems to provide additional effects. Existing antimicrobials do not maintain a sufficient subgingival concentration for a period longer than 24h. A mucoadhesive biodegradable xanthan-based gel containing a mixture of chlorhexidine digluconate and chlorhexidine dihydrochloride (ratio 1:2) combines the the rapid release action of the first with the long-lasting release of the latter.
Objectives
Aim of the present study was to evaluate the clinical effects of topical subgingival application of a new biodegradable xanthan-based chlorhexidine-gel adjunctive to initial periodontal therapy when compared with a regular chlorhexidine-gel in a controlled randomized split-mouth clinical study.
Material and Methods
Eight patients (four male and for female, aged between 28-52), light- or non-smokers, suffering of chronic periodontitis and displaying each periodontal pockets deeper than 5 mm underwent a periodontal examination at baseline and after four weeks. This included the assessment of PI, BOP, PD, and CAL. PD and CAL were recorded at six sites per tooth. A total of 188 teeth (1128 sites) were examined. The maximal values of PD and CAL per quadrant were taken into account in this study. Each patient received SRP during initial therapy according to the one-stage Full Mouth Disinfection (Quirinen, 1995). In addition, each quadrant of the same arch was assigned to randomly receive a single subgingival application of either a novel xanthane-based gel containing a mixture of chlorhexidine digluconate and chlorhexidine dihydrochloride (Chlosite®, Ghimas s.p.a., Casalecchio di Reno, Italy) or the chlorhexidine-gel PlakOut®, Santa Balanos, Greece). Chlosite® was delivered from a syringe with a thin rounded tip needle into the debrided periodontal pockets after careful drying of the latter. Subsequently, patients were advised to use 0,2% chlorhexidine mouthwashes (PlakOut®, Santa Balanos, Greece), twice a day, for the following four weeks, and OHI were reinforced. The Wilcoxon test was used to compare the differences between the baseline and four weeks after and for the differences between the groups.
|
| Fig 1: Application of the xanthane-based chlorhexidine gel Chlosite® (Ghimas s.p.a., Italy) |
Results
The healing phase progressed uneventful. No signs of inflammation, infection, allergy or severe pain were present. Pre- and post-treatment maximal values per quadrant of the PD, CAL, PI and BOP in the two treated groups are displayed in the table No.1 and table No.2., and the mean differences between the groups are presented in the table No.3.
|
Nr.
|
mean maximal
PD/quadrant
at baseline
|
mean maximal
PD/quadrant
at one month
|
Δ mean maximal
PD/quadrant
|
mean maximal
CAL/quadrant baseline
|
mean maximal
CAL at one month
|
Δ mean maximal
CAL
|
PI
baseline
|
PI one
month
|
Δ PI
|
BOP
baseline (%)
|
BOP at one
month (%)
|
Δ BOP (%)
|
|
1
|
9
|
6
|
3
|
9
|
6
|
3
|
.43
|
.15
|
0.28
|
34
|
15
|
19.00
|
|
2
|
12
|
4
|
8
|
12
|
4
|
8
|
1.00
|
1.13
|
-0.13
|
44
|
30
|
14.00
|
|
3
|
12
|
6
|
6
|
12
|
8
|
4
|
2.27
|
.08
|
2.19
|
42
|
24
|
18.00
|
|
4
|
8
|
6
|
2
|
8
|
6
|
2
|
.67
|
.85
|
-0.18
|
57
|
29
|
28.00
|
|
5
|
9
|
5
|
4
|
9
|
5
|
4
|
1.50
|
.00
|
1.50
|
94
|
18
|
76.00
|
|
6
|
8
|
2
|
6
|
8
|
9
|
-1
|
1.40
|
1.50
|
-0.10
|
63
|
15
|
48.00
|
|
7
|
5
|
3
|
2
|
5
|
5
|
0
|
.65
|
.43
|
0.22
|
84
|
8
|
75.70
|
|
8
|
8
|
7
|
1
|
9
|
7
|
2
|
.95
|
.48
|
0.47
|
66
|
57
|
9.00
|
|
MEAN ± SD
|
8.88 ± 2.30
|
4.88 ± 1.73
|
4.00 ± 2.45
|
9.00 ± 2.27
|
6.25 ± 1.67
|
2.75 ± 2.76
|
1.1 ± 0.59
|
0.57 ± 0.53
|
0.53 ± 0.86
|
60.50 ± 20.83
|
24.54 ± 15.08
|
35.96 ± 27.28
|
| |
|
|
p=0.012
|
|
|
p=0.027
|
|
|
|
|
|
|
| Tab. 1: One month clinical results of treatment of periodontal pockets with Chlosite®
|
|
Nr.
|
mean maximal PD/quadrant at baseline
|
mean maximal PD/quadrant at one month
|
Δ mean maximal PD/quadrant
|
mean maximal CAL/quadrant baseline
|
mean maximal CAL at one month
|
Δ mean maximal CAL
|
PI baseline
|
PI one month
|
Δ PI
|
BOP baseline (%)
|
BOP at one month (%)
|
Δ BOP (%)
|
|
1
|
10
|
6
|
4
|
10
|
7
|
3
|
0.43
|
0.15
|
0.28
|
34.00
|
15.00
|
19.00
|
|
2
|
10
|
7
|
3
|
10
|
7
|
3
|
1
|
1.13
|
-0.13
|
44.00
|
30.00
|
14.00
|
|
3
|
10
|
10
|
0
|
10
|
16
|
-6
|
2.27
|
0.08
|
2.19
|
42.00
|
24.00
|
18.00
|
|
4
|
7
|
7
|
0
|
7
|
7
|
0
|
0.67
|
0.85
|
-0.18
|
57.00
|
29.00
|
28.00
|
|
5
|
8
|
4
|
4
|
8
|
4
|
4
|
1.5
|
0
|
1.50
|
94.00
|
18.00
|
76.00
|
|
6
|
10
|
9
|
1
|
10
|
9
|
1
|
1.4
|
1.5
|
-0.10
|
63.00
|
15.00
|
48.00
|
|
7
|
6
|
3
|
3
|
6
|
3
|
3
|
0.65
|
0.43
|
0.22
|
84.00
|
8.30
|
75.70
|
|
8
|
10
|
6
|
4
|
10
|
6
|
4
|
0.95
|
0.48
|
0.47
|
66.00
|
57.00
|
9.00
|
|
MEAN ± SD
|
8.88 ± 1.64
|
6.50 ± 2.33
|
2.38 ± 1.77
|
8.88 ± 1.64
|
7.38 ± 3.96
|
1.50 ± 3.34
|
1.1 ± 0.59
|
0.57 ± 0.53
|
0.53 ± 0.86
|
60.50 ± 20.83
|
24.54 ± 15.08
|
35.96 ± 27.28
|
| |
|
|
p=0.026
|
|
|
p=0.233
|
|
|
|
|
|
|
| Tab. 2: One month clinical results of treatment of periodontal pockets with PlakOut®
|
|
|
| Fig. 2 left: Probing reveals periodontal pockets |
Fig. 2 right: Chlosite® in situ with marginal overflow |
|
| Fig 3: Split-mouth application of Chlosite® (left side of picture) and PlakOut® (right side of picture) |
Both therapies resulted in significant improvements in all clinical indices. At four weeks after application, in the Chlosite group the mean PD changed from 8.88±2.30 to 4.88±1.73 (p=0.012) and the CAL changed from 9.00±2.27 to 6.25±1.67 (p=0.027), while in the PlakOut group the PD changed from 8.88±1.64 to 6.50±2.33 (p=0.026) and the CAL changed from 8.88±1.64 to 7.38±3.96 (p=0.233). The Chlosite group resulted in slightly higher CAL gains (mean D=1.25 mm) and PD reductions (mean D=1.62 mm) than the PlakOut group, but these differences were not statistically significant due to the low number of cases
|
Parameter
|
No. sites
|
Mean Δ Chlosite ®
|
Mean Δ PlakOut ®
|
Mean Δ between groups
|
p
|
|
|
|
Mean
|
SD
|
Mean
|
SD
|
|
|
|
PD
|
32
|
4.00
|
2.45
|
2.38
|
1.77
|
1.62
|
n.s.
|
|
CAL
|
32
|
2.75
|
2.76
|
1.50
|
3.34
|
1.25
|
n.s.
|
| Tab. 3: One month clinical results of treatment of periodontal pockets with PlakOut®
|
Conclusion
Following both initial therapy approaches, there were marked clinical improvements at four weeks from baseline. Additional topical subgingival application of Chlosite is safe and provided more favorable CAL gain and PD reduction than PlakOut. The use of Chlosite® may further increase the non-surgical indication of treatment for periodontal patients.
Abbreviations
PD - probing depth
CAL - clinical attachment level
PI-plaque index (Silness, Loe, 1963)
BOP-bleeding on probing
This Poster was submitted by Assist. Prof. Dr. Dr. Stefan-Ioan Stratul.
Correspondence address:
Dr. Darian Rusu
c/o Assist. Prof. Dr. Dr. Stefan-Ioan Stratul
str.Em.Gojdu, no.5
300176 Timisoara
Romania
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