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Title: Managing severe periodontal disease patients displaying deep
angular bony defects: Periodontal surgery with or without use of Emdogain?
Hiroshi Miyashita
(Cochrane Oral Health Reviewer Group)
Clinical scenario: Mrs. K (aged 31) was referred for the treatment of localized severe periodontal disease. The referring dentist has been treating her problems thoroughly, non-surgically, for years. Although
her compliance and oral hygiene appeared almost perfect, there were several
sites with deep periodontal pockets (~ 8mm) and radiographs showed angular bony defects at those sites. As a specialist in periodontology you know that you usually obtain reasonably good
results from your conventional surgical technique.
However, you have been impressed by recent information reporting the successful
results of EmdogainⓇ (A new
technique for periodontal regeneration) when combined with periodontal
surgery for the treatment of deep periodontal
defects. You wonder: ‘Does EmdogainⓇ treatment combined with
periodontal surgery produce better clinical
outcomes than conventional periodontal surgery alone?’
Step 1: Formulating an answerable
question
My specific question was made using following four parts.
Patients: Adult periodontal patients (aged 20 or more)
Intervention: Periodontal surgery accompanied by EmdogainⓇ
Comparison: Periodontal surgery alone
Outcome: Probing pocket depth and probing attachment level and also
quality of life for my patient
Step 2:
Searching relevant information
To solve my question I need to identify keywords in each of the
parts of the question created in Step 1, in order to search the electronic
databases. Having some time, I searched Medline and the Cochrane Library and
also hand searched the Journal of
Clinical Periodontology for 2002. The search used was as follows:
Periodont* AND ((enamel NEAR matrix) OR (enamel NEAR protein) OR (enamel
NEXT matrix NEXT derivative) OR (EMDOGAINⓇ OR EmdogainⓇ))
Hits: There were 15 articles from Medline, 15 from Cochrane and
2 from my hand search. After duplicates were removed,
and also studies that did not compare EmdogainⓇ and surgery with surgery alone, this resulted in 8 articles (Table 1).
Step 3: Critical appraisal of papers
Next step is to critically appraise the relevant papers. In
this case study, I selected only one paper from the listed articles. Those
articles are all randomized controlled study that compare the clinical
differences between the conventional surgical technique and that with an
additional use of EmdogainⓇ. The
selection was done by reading a title and abstract of all the papers and
collected some information from those and listed them (Table 2). According to
the information from the table, I realized there are three types of studies
published at present. These studies can be classified as the investigations of
clinical effectiveness of EmdogainⓇ use applied to
the recession type defects, angular bony defect treated by non-surgical means
and angular bony defect treated by surgical means. Mrs. K, my patient,
displayed the deep pockets with angular bony defects and I planned to perform
surgery for such sites. This made me the decision to read a paper published by
Heijl et al. (1997), because this study included largest samples with
split-mouth design, placebo use and longest follow-up, meaning a very well
designed study among the others.
Critical
appraisal:
In order to
critically appraise the paper, a check list for therapy published in the User’s
Guide to the medical literature (9) was used. The points to be checked are
described in Table 3. Selected article was very well designed and that all the
check points were written in the article how they performed and were proper.
The follow-up rate after 36 months is 79% (3 patients drop out and other 4
patients did not complete final examinations) and this may be acceptable for
clinical study. I made a decision that the bias from this study seemed very
limited and continue to read results from this study guided by the check list
again.
In the
periodontal literature, many types of surrogate endopoints are usually
measured. The most interesting outcome for the operator is clinical attachment
gain after the treatment. The results showed 0.5mm difference between 2 types
of treatments that applied to the periodontal sites with initial attachment
level and probing depth of around 9.4mm and 7.8mm, respectively. This 0.5mm
difference is statistically significant (p<0.01). It may be pointed out that
it could be a real effect from the EmdogainⓇ treatment
itself. However, this could be interpreted as clinically insignificant due to
the fact that measurement error inherent in the probing assessment which
usually have +-1mm difference even for the measurements of the same sites at
different time points by the same assessor. The results must be interpreted
with care not only from the point estimate (mean value) but also from the
distribution of the raw data. The confidence interval of the difference of
clinical attachment gain was not reported.
Other
interesting outcome reported in this study is the adverse effect after
treatments. The occurrence of the adverse effects was seen in 12% of the
subjects (4 subjects), however, all cases were regarded as minor problems.
This study
calculated a sample size beforehand by assuming the difference of clinical
attachment gain between two techniques for 1mm and power of the statistics for
90%. The statistics showed significant outcome, however, the power to detect
the significance between two techniques may not be enough after the study was
completed.
Summary and
points for practice/implementation:
The study by
Heijl et al. (1997) shows very good validity and bias seems very limited. The
periodontal surgery combined with EmdogainⓇ did show
statistically significant clinical attachment gain. However, such a difference
was very small (0.5mm) and that the clinical significance may not be established
strongly. It should be bare in mind that this study selected one-wall and
two-wall defects for the experiments. Those sites were believed to be very
difficult sites to resolve periodontal problems by conventional therapy. These results must be applied to the similar type of defect
of our own patients. Actually, the type of the defect at the site to be treated
is difficult to assume from clinical findings. This means that the decision
whether or not to use EmdogainⓇ can only be
made after opening the flap during surgery. And if one-wall defect or 2-wall
defect can be found during surgery, then the chance of gaining clinical
effectiveness of the EmdogainⓇ use is similar
than that be gained by conventional surgery alone. On the other hand, the utility
of EmdogainⓇ to the three-wall defect should be
interpreted from other studies. In order to generalize the clinical
effectiveness of EmdogainⓇ use might be
further analysed by including more studies treating different types of
periodontal problems.
This study was
selected for critical appraisal because of the largest sample size among
randomized controlled trials of EmdogainⓇ comparing a
conventional surgery as control treatment. Actually the sample size was
calculated beforehand in this study. However, the power of the statistics was
not enough in the end. In reality, it could be very difficult to draw any
general conclusion from one study. In this sense combining more studies
together could be one solution to lead more appropriate conclusion. Probably, a
systematic review accompanied by a meta-analysis may be the next step.
Table 1.
|
No. |
Author |
Year |
Comparison |
|
|
|
Excluded |
Included |
|
|
|
|
|
Control |
Test |
|
|
|
|
|
|
|
|
|
Surg |
Test A |
Test B |
Test C |
Test D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Camargo |
2001 |
OFD |
BPBM+EMD |
|
|
|
* |
|
|
2 |
Bratthall |
2001 |
|
EMD 2 |
EMD 1 |
|
|
* |
|
|
5 |
Lekovic |
2001 |
OFD |
BPBM+EMD |
GTR |
|
|
* |
|
|
6 |
Sculean |
2001 |
CRF |
EMD+GTR |
EMD |
|
|
|
* |
|
7 |
Sculean |
2001 |
|
EMD+anti |
EMD |
|
|
* |
|
|
8 |
Froum |
2001 |
OFD |
EMD |
|
|
|
|
* |
|
9 |
Okuda |
2000 |
OFD+p |
EMD |
|
|
|
|
* |
|
10 |
Modica |
2000 |
CRF |
EMD |
|
|
|
|
* |
|
11 |
Lekovic |
2000 |
|
BPBM+EMD |
EMD |
|
|
* |
|
|
12 |
Silvestri |
2000 |
MWF |
EMD |
GTR |
|
|
|
* |
|
13 |
Sculean |
1999 |
|
EMD |
GTR |
|
|
* |
|
|
14 |
Pontoriero |
1999 |
|
EMD |
GTR 1 |
GTR 2 |
GTR 3 |
* |
|
|
15 |
Sculean |
1999 |
|
EMD |
GTR |
|
|
* |
|
|
16 |
Heijl |
1997 |
MWF+p |
EMD |
|
|
|
|
* |
|
18 |
Zetterstrom |
1997 |
OFD |
EMD |
|
|
|
* |
|
|
19 |
Wennstrom |
2002 |
SRP+p |
EMD |
|
|
|
|
* |
|
20 |
Hagewald |
2002 |
CRF+p |
EMD |
|
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
OFD … Open flap debridement
BPBM … Bovine porous bone mineral
EMD … Enamel matrix protein/
derivative/ EmdogainⓇ
CRF … Coronally repositioned (advanced) flap
MWF … modified Widman flap
p … placebo
Table 2.
|
Author |
Year |
Comparison |
Patients |
Groups |
Conceal |
Random |
Design |
|
Follow-Up |
|
|
|
Control |
|
|
|
|
Split-mouth |
Pararell |
|
|
Infrabony defect (surgical) |
|
|
|
|
|
|
|||
|
Silvestri 1) |
2000 |
MWF |
30 |
3 groups |
--- |
--- |
x |
10vs10 |
1 year |
|
Sculean 2) |
2001 |
---- |
56 |
4 groups |
Yes |
Yes |
x |
14vs14 |
1 year |
|
Froum 3) |
2001 |
OFD |
23 |
2 groups |
-- |
--- |
x |
31vs53 |
1 year |
|
Okuda 4) |
2000 |
OFD+p |
16 |
2 groups |
Yes |
Yes |
18vs18 |
x |
1 year |
|
Heijl 5) |
1997 |
MWF+p |
33 |
2 groups |
Yes |
Yes |
34vs34 |
x |
3 year |
|
|
|
|
|
|
|
|
|
|
|
|
Infrabony defect (non-surgical) |
|
|
|
|
|
||||
|
Wennstrom 6) |
2002 |
SRP+p |
28 |
2 groups |
Yes |
Yes |
84vs84 |
x |
3 weeks |
|
|
|
|
|
|
|
|
|
|
|
|
Recession type defect (surgical) |
|
|
|
|
|
||||
|
Modica 7) |
2000 |
CRF |
12 |
2 groups |
--- |
Yes |
14vs14 |
x |
6 months |
|
Hagewald 8) |
2002 |
CRF+p |
37 |
2 groups |
Yes |
Yes |
36vs36 |
x |
1 year |
|
|
|
|
|
|
|
|
|
|
|
--- … Data not
described in the abstract
Tabel 3.
Are the
results valid?
1. Were
patients randomized?
2. Was
randomization concealed?
3. Were patients
analyzed in the groups to which they were randomized?
4. Were
patients in the treatment and control groups similar with respect to known
prognostic variables?
5. Were
patients aware of group allocation?
6. Were
clinicians aware of group allocation?
7. Were
outcome assessors aware of group allocation?
8. Was
follow-up complete?
What are the
results?
9. How large
was the treatment effect?
10. How
precise was the estimate of the treatment effect?
11. When
authors do not report the condidence interval?
How can I
apply the results to patient care?
12. Were the
study patients similar to the patients in my practice?
13. Were all
clinically important outcomes considered?
14. Are the
likely treatment benefits worth the potential harm and costs?
Reference
1.
Silvestri M, Ricci
G, Rasperini G, Sartori S, Cattaneo V. Comparison of treatments of
infrabony defects with enamel matrix derivative, guided tissue regeneration
with a nonresorbable membrane and Widman modified flap. A pilot study. J
Clin Periodontol. 2000;27(8):603-10.
2.
Sculean A,
Windisch P, Chiantella GC, Donos N, Brecx M, Reich E. Treatment of intrabony defects
with enamel matrix proteins and guided tissue regeneration. A prospective
controlled clinical study. J Clin Periodontol. 2001;28(5):397-403.
3.
Froum SJ, Weinberg
MA, Rosenberg E, Tarnow D. A comparative study utilizing open flap debridement with and without
enamel matrix derivative in the treatment of periodontal intrabony defects: a
12-month re-entry study. J Periodontol.
2001;72(1):25-34.
4. Okuda K,
Momose M, Miyazaki A, et al. Enamel matrix derivative in the treatment of human intrabony osseous
defects. J Periodontol. 2000;71(12):1821-8.
5.
Heijl L, Heden G,
Svardstrom G, Ostgren A. Enamel matrix derivative (EMDOGAIN) in the treatment of intrabony
periodontal defects. J Clin Periodontol. 1997;24(9 Pt 2):705-14.
6.
Wennstrom JL,
Lindhe J. Some effects of
enamel matrix proteins on wound healing in the dento-gingival region. J Clin
Periodontol. 2002;29(1):9-14.
7.
Modica F, Del
Pizzo M, Roccuzzo M, Romagnoli R. Coronally advanced flap for the treatment of buccal gingival recessions
with and without enamel matrix derivative. A split-mouth study. J
Periodontol. 2000;71(11):1693-8.
8.
Hagewald S, Spahr
A, Rompola E, Haller B, Heijl L, Bernimoulin JP. Comparative study of Emdogain and
coronally advanced flap technique in the treatment of human gingival
recessions. A prospective controlled clinical study. J Clin Periodontol.
2002;29(1):35-41.
9.
Guyatt G, Cook D, Devereaux PD, Maede M, Straus S. Users’ guides to the medical literature. JAMA. 2002;81-82.
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Copyrights(c) 2001 Hiroshi Miyashita DDS.