Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects

Marco Esposito; Maria Gabriella Grusovin; Nikolaos Papanikolaou; Paul Coulthard; Helen V Worthington

doi:10.1002/14651858.CD003875.pub3

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Figure 1

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.1 PAL.

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Figure 2

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.6 Aesthetics (continuous data).

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Figure 3

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.7 Aesthetics (dichotomous data).

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Figure 4

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.2 PAL < 2 mm.

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Figure 5

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.3 PPD.

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Figure 6

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.4 REC.

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Figure 7

Forest plot of Comparison 1 Emdogain versus control: 1 year; Outcome 1.5 Marginal bone level.

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Figure 8

Forest plot of Comparison 2 Emdogain versus GTR: 1 year; Outcome 2.1 PAL.

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Figure 9

Forest plot of Comparison 2 Emdogain versus GTR: 1 year; Outcome 2.4 Postoperative complications.

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Figure 10

Forest plot of Comparison 2 Emdogain versus GTR: 1 year; Outcome 2.2 PPD.

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Figure 11

Forest plot of Comparison 2 Emdogain versus GTR: 1 year; Outcome 2.3 REC.

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Figure 12

Forest plot of Comparison 2 Emdogain versus GTR: 1 year; Outcome 2.5 Marginal bone level.

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Figure 13

Forest plot of Comparison 3 Emdogain versus bone graft; Outcome 3.1 PAL.

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Figure 14

Forest plot of Comparison 3 Emdogain versus bone graft; Outcome 3.2 PPD.

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Figure 15

Forest plot of Comparison 3 Emdogain versus bone graft; Outcome 3.3 REC.

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Analysis 1.1

Comparison 1 Emdogain versus control: 1 year, Outcome 1 PAL.

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Analysis 1.2

Comparison 1 Emdogain versus control: 1 year, Outcome 2 PAL < 2 mm.

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Analysis 1.3

Comparison 1 Emdogain versus control: 1 year, Outcome 3 PPD.

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Analysis 1.4

Comparison 1 Emdogain versus control: 1 year, Outcome 4 REC.

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Analysis 1.5

Comparison 1 Emdogain versus control: 1 year, Outcome 5 Marginal bone level.

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Analysis 1.6

Comparison 1 Emdogain versus control: 1 year, Outcome 6 Aesthetics (continuous data).

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Analysis 1.7

Comparison 1 Emdogain versus control: 1 year, Outcome 7 Aesthetics (dichotomous data).

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Analysis 2.1

Comparison 2 Emdogain versus GTR: 1 year, Outcome 1 PAL.

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Analysis 2.2

Comparison 2 Emdogain versus GTR: 1 year, Outcome 2 PPD.

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Analysis 2.3

Comparison 2 Emdogain versus GTR: 1 year, Outcome 3 REC.

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Analysis 2.4

Comparison 2 Emdogain versus GTR: 1 year, Outcome 4 Postoperative complications.

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Analysis 2.5

Comparison 2 Emdogain versus GTR: 1 year, Outcome 5 Marginal bone level.

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Analysis 3.1

Comparison 3 Emdogain versus bone graft, Outcome 1 PAL.

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Analysis 3.2

Comparison 3 Emdogain versus bone graft, Outcome 2 PPD.

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Analysis 3.3

Comparison 3 Emdogain versus bone graft, Outcome 3 REC.

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Emdogain compared with Control for periodontal tissue regeneration in intrabony defects
Patient or population:patients with intrabony defects Settings: practice Intervention: Emdogain Comparison: Control flap surgery
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control flap surgery	Emdogain
Tooth loss	See comment	See comment		371 [9]	See comment	too few teeth lost to undertake analysis
PAL¹ mm gain from baseline 1 year	The mean PAL gain ranged across control groups from 0.8 to 2.2	The mean PAL gain in the intervention groups was 1.1 higher (0.6 to 1.6 higher)		371 [9]	++OO low
Aesthetics	The mean VAS score for the control group was 62	The mean VAS gain in the intervention groups was 1.0 higher (‐5.4 to 7.4)		166 [1]	++OO low
PPD² mm reduction from baseline 1 year	The mean PPD reduction ranged across control groups from 1.4 to 4.5	The mean PPD reduction in the intervention groups was 0.7 higher (0.5 to 1.0 higher)		371 [9]	++OO low
REC³ mm change from baseline 1 year	The mean REC ranged across control groups from ‐1.7 to ‐0.2	The mean REC in the intervention groups was 0.02 higher (‐0.3 to 0.3 higher)(less recession)		302 [6]	++OO low
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; GRADE: GRADE Working Group grades of evidence (see explanations)
GRADE Working Group grades of evidence High quality (++++): Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality (++OO): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality (+OOO): We are very uncertain about the estimate. 1 probing attachment level 2 probing pocket depth 3 gingival recession

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Emdogain compared with GTR for periodontal tissue regeneration in intrabony defects
Patient or population:patients with intrabony defects Settings: practice Intervention: Emdogain Comparison: GTR
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	GTR⁴	Emdogain
Tooth loss	See comment	See comment		237 [5]	See comment	too few teeth lost to undertake analysis
PAL¹ mm gain from baseline 1 year	The mean PAL gain ranged across GTR groups from 2.5 to 4.9	The mean PAL gain in the intervention groups was 0.2 lower (‐0.20 to 0.55 lower)		304 [6]	++OO low
PPD² mm reduction from baseline 1 year	The mean PPD reduction ranged across GTR groups from 3.3 to 6.5	The mean PPD reduction in the intervention groups was 0.4 lower (‐0.2 to 1.1 lower)		304 [6]	++OO low
Aesthetics	See comment	See comment		0 [0]	See comment	No studies reported this
REC³ mm change from baseline 1 year	The mean REC change ranged across GTR groups from ‐1.8 to 1.0	The mean REC change in the intervention groups was 0.4 higher (0.2 to 0.7 higher)(less recession)		206 [5]	++OO low
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; GRADE: GRADE Working Group grades of evidence (see explanations)
GRADE Working Group grades of evidence High quality (++++): Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality (++OO): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality (+OOO): We are very uncertain about the estimate. 1 probing attachment level 2 probing pocket depth 3 gingival recession 4 Guided Tissue Regeneration

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Table 1. Results of quality assessment after correspondence with authors

Study	Concealment of allocation	Blinding of assessor	Reasons for drop outs	Risk of bias
Heijl 1997	Yes	Yes	Reasons given	Low
Pontoriero 1999	Unclear	Yes	No drop outs	High
Okuda 2000	Yes	Yes	No drop outs	Low
Silvestri 2000	No	No	No drop outs	High
Tonetti 2002	Yes	No	Reasons given	High
Zucchelli 2002	Unclear	Yes	No drop outs	High
Silvestri 2003	Yes	No	Reasons given	High
Francetti 2004	Yes	No	No drop outs	High
Sanz 2004	Yes	No	No reasons given	High
Rösing 2005	Yes	Yes	Reasons given	Low
Crea 2008	Yes	Yes	Reasons given	Low
Grusovin 2009	Yes	Yes	Reasons given	Low
Leknes 2009	Yes	Yes	No drop outs	Low

Table 1. Results of quality assessment after correspondence with authors

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Table 2. Control versus Emdogain: PAL at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Silvestri 2000	P	10 4.5 (1.58)	10 1.20 (1.03)	20 3.30 (0.60)
Tonetti 2002	P	83 3.1 (1.5)	83 2.5 (1.5)	166 0.60 (0.23)
Zucchelli 2002	P	30 4.2 (0.9)	30 2.6 (0.8)	60 1.6 (0.22)
Francetti 2004	P	12 4.14 (1.35)	12 2.29 (0.95)	24 1.85 (0.48)
Grusovin 2009	P	15 3.4 (1.1)	15 3.3 (1.2)	30 0.1 (0.42)
Heijl 1997	S	31 2.3 (1.6)	31 1.7 (1.2)	31 0.6 (0.22)
Pontoriero 1999	S	10 3.0	10 1.8	10 1.1 (0.43)
Okuda 2000	S	16 1.72 (1.07)	16 0.83 (0.86)	16 0.89 (0.22)
Rosing 2005	S	14 2.01 (1.76)	14 2.16 (1.87)	14 ‐0.15 (0.69) (0.90)*
*authors' value from e‐mail PAL = probing attachment level SD = standard deviation SE = standard error

Table 2. Control versus Emdogain: PAL at 1 year

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Table 3. Control versus Emdogain: PPD at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Silvestri 2000	P	10 4.9 (1.79)	10 1.40 (1.26)	20 3.5 (0.69)
Tonetti 2002	P	83 3.9 (1.7)	83 3.3 (1.7)	166 0.60 (0.26)
Zucchelli 2002	P	30 5.1 (0.7)	30 4.5 (1.0)	60 0.60 (0.22)
Francetti 2004	P	12 4.71 (1.60)	12 2.57 (1.27)	24 2.14 (0.59)
Grusovin 2009	P	15 3.9 (1.0)	15 4.2 (1.6)	30 0.3 (0.49)
Heijl 1997	S	31 3.3 (1.4)	31 2.6 (1.2)	31 0.70 (0.25)
Pontoriero 1999	S	10 4.4	10 3.5	10 0.7 (0.47)
Okuda 2000	S	16 3.0 (0.97)	16 2.22 (0.81)	16 0.78 (0.32)
Rosing 2005	S	14 4.17 (1.80)	14 4.39 (1.14)	14 ‐0.22 (0.57) (0.64)*
*authors' value from e‐mail PPD = probing pocket depth SD = standard deviation SE = standard error

Table 3. Control versus Emdogain: PPD at 1 year

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Table 4. Control versus Emdogain: REC at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Silvestri 2000	P	10 ‐0.5 (0.97)	10 ‐0.20 (0.63)	20 ‐0.30 (0.37)
Tonetti 2002	P	83 ‐0.8 (1.2)	83 ‐0.8 (1.2)	166 0 (0.19)
Zucchelli 2002	P	30 ‐1.0 (0.5)	30 ‐1.6 (1.0)	60 0.60 (0.20)
Grusovin 2009	P	15 ‐0.8 (1.0)	15 ‐0.6 (1.1)	30 ‐0.2 (0.38)
Pontoriero 1999	S	10 ‐1.7	10 ‐1.7	10 0 (0.34)
Okuda 2000	S	16 ‐1.22 (0.16)	16 ‐1.22 (0.88)	16 0 (0.27)
REC = gingival recession SD = standard deviation SE = standard error

Table 4. Control versus Emdogain: REC at 1 year

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Table 5. Random‐effects metaregression analysis of outcomes PAL, PPD, REC

Characteristic	Outcome	Studies	Slope estimate (SE)	95% CI	Slope	P value
Parallel versus split mouth	PAL	9	0.68 (0.63)	(‐0.81, 2.19)	Emdogain in parallel group trials has higher effect	0.31
Parallel versus split mouth	PPD	9	0.71 (0.66)	(‐0.87, 2.28)	Emdogain in parallel group trials has higher effect	0.32
Parallel versus split mouth	REC	6	0.28 (0.36)	(‐0.72, 1.28)	Emdogain in parallel group trials has higher effect	0.48
CI = confidence interval PAL = probing attachment level PPD = probing pocket depth REC = gingival recession

Table 5. Random‐effects metaregression analysis of outcomes PAL, PPD, REC

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Table 6. GTR versus Emdogain: PAL at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Pontoriero 1999	P	10 2.9 (1.5)	10 2.9 (1.1)	20 0 (0.59)
Silvestri 2000	P	10 4.5 (1.58)	10 4.80 (2.10)	20 ‐0.30 (0.83)
Zucchelli 2002	P	30 4.2 (0.9)	30 4.9 (1.6)	60 ‐0.70 (0.34)
Silvestri 2003	P	49 4.1 (1.8)	49 4.3 (1.9)	98 ‐0.20 (0.38)
Sanz 2004	P	35 3.1 (1.8)	32 2.5 (1.9)	67 0.60 (0.45)
Crea 2008	P	19 2.7	20 2.8	39 0.1 (0.66)
GTR = guided tissue regeneration PAL = probing attachment level SD = standard deviation SE = standard error

Table 6. GTR versus Emdogain: PAL at 1 year

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Table 7. GTR versus Emdogain: PPD at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Pontoriero 1999	P	10 4.2 (1.3)	10 4.7 (1.4)	20 ‐0.50 (0.60)
Silvestri 2000	P	10 4.9 (1.79)	10 5.7 (1.06)	20 ‐0.80 (0.66)
Zucchelli 2002	P	30 5.1 (0.7)	30 6.5 (1.6)	60 ‐1.40 (0.32)
Silvestri 2003	P	49 5.3 (1.9)	49 5.6 (1.5)	98 ‐0.30 (0.35)
Sanz 2004	P	35 3.8 (1.5)	32 3.3 (1.5)	67 0.50 (0.37)
Crea 2008	P	19 3.4	20 3.6	39 ‐0.2 (0.45)
GTR = guided tissue regeneration PPD = probing pocket depth SD = standard deviation SE = standard error

Table 7. GTR versus Emdogain: PPD at 1 year

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Table 8. GTR versus Emdogain: REC at 1 year

Study	Parallel group/Split mouth	EMD n mean (SD)	Control n mean (SD)	Difference n mean (SE)
Pontoriero 1999	P	10 ‐1.3 (0.9)	10 ‐1.8 (0.9)	20 0.50 (0.40)
Silvestri 2000	P	10 ‐0.5 (0.97)	10 ‐0.95 (1.40)	20 0.45 (0.54)
Zucchelli 2002	P	30 ‐1.0 (0.5)	30 ‐1.6 (1.0)	60 0.60 (0.20)
Sanz 2004	P	35 ‐0.6 (0.9)	32 ‐0.7 (0.9)	67 0.1 (0.22)
Crea 2008	P	19 ‐0.6	20 1.0	39 0.6 (0.478)
GTR = guided tissue regeneration REC = gingival recession SD = standard deviation SE = standard error

Table 8. GTR versus Emdogain: REC at 1 year

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Comparison 1. Emdogain versus control: 1 year

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PAL Show forest plot	9	442	mean difference (Random, 95% CI)	1.08 [0.61, 1.55]

1.1 Parallel group	5	300	mean difference (Random, 95% CI)	1.40 [0.57, 2.24]
1.2 Split mouth	4	142	mean difference (Random, 95% CI)	0.76 [0.48, 1.04]
2 PAL < 2 mm Show forest plot	6	362	risk ratio (Random, 95% CI)	0.53 [0.34, 0.82]

3 PPD Show forest plot	9	442	Mean difference (Random, 95% CI)	0.88 [0.44, 1.31]

3.1 Parallel group	5	300	Mean difference (Random, 95% CI)	1.25 [0.44, 2.05]
3.2 Split mouth	4	142	Mean difference (Random, 95% CI)	0.66 [0.31, 1.00]
4 REC Show forest plot	6	328	mean difference (Random, 95% CI)	0.09 [‐0.20, 0.37]

4.1 Parallel group	4	276	mean difference (Random, 95% CI)	0.09 [‐0.33, 0.52]
4.2 Split mouth	2	52	mean difference (Random, 95% CI)	0.0 [‐0.41, 0.41]
5 Marginal bone level Show forest plot	3	120	mean difference (Random, 95% CI)	0.69 [‐0.53, 1.92]

5.1 Parallel group	1	30	mean difference (Random, 95% CI)	0.0 [‐0.82, 0.82]
5.2 Split mouth	2	90	mean difference (Random, 95% CI)	1.08 [‐0.72, 2.89]
6 Aesthetics (continuous data) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

6.1 Parallel group	1	166	Mean Difference (IV, Random, 95% CI)	1.0 [‐5.42, 7.42]
7 Aesthetics (dichotomous data) Show forest plot	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.02, 8.07]

Comparison 1. Emdogain versus control: 1 year

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Comparison 2. Emdogain versus GTR: 1 year

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PAL Show forest plot	6	304	mean difference (Random, 95% CI)	‐0.15 [‐0.56, 0.25]

1.1 Parallel group	6	304	mean difference (Random, 95% CI)	‐0.15 [‐0.56, 0.25]
1.2 Split mouth	0	0	mean difference (Random, 95% CI)	0.0 [0.0, 0.0]
2 PPD Show forest plot	6	304	mean difference (Random, 95% CI)	‐0.44 [‐1.06, 0.18]

2.1 Parallel group	6	304	mean difference (Random, 95% CI)	‐0.44 [‐1.06, 0.18]
2.2 Split mouth	0	0	mean difference (Random, 95% CI)	0.0 [0.0, 0.0]
3 REC Show forest plot	5	206	mean difference (Random, 95% CI)	0.41 [0.15, 0.66]

3.1 Parallel group	5	206	mean difference (Random, 95% CI)	0.41 [0.15, 0.66]
3.2 Split mouth	0	0	mean difference (Random, 95% CI)	0.0 [0.0, 0.0]
4 Postoperative complications Show forest plot	3	201	Risk Ratio (M‐H, Random, 95% CI)	0.12 [0.02, 0.85]

4.1 Parallel group	3	201	Risk Ratio (M‐H, Random, 95% CI)	0.12 [0.02, 0.85]
5 Marginal bone level Show forest plot	1	39	Mean Difference (IV, Fixed, 95% CI)	‐0.60 [‐1.34, 0.14]

Comparison 2. Emdogain versus GTR: 1 year

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Comparison 3. Emdogain versus bone graft

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PAL Show forest plot	1	26	Mean Difference (Random, 95% CI)	0.6 [‐0.14, 1.34]

2 PPD Show forest plot	1	26	Mean Difference (Random, 95% CI)	0.1 [‐1.08, 1.28]

3 REC Show forest plot	1	26	Mean Difference (Random, 95% CI)	‐1.6 [‐2.74, ‐0.46]

Comparison 3. Emdogain versus bone graft

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