Cochrane · intervention · CD003875
Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects
Esposito, M, Grusovin, MG, Papanikolaou, N, et al. · Cochrane Database of Systematic Reviews · 2009 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
22
current version
GRADE rated
7
No studies
3
Included studies
13
as reported
No studies 3 · 13.6%Ungraded 12 · 54.5%Very low 0 · 0%Low 7 · 31.8%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm; depths could be assessed on intraoral radiographs but intrasurgical measurements preferred; trials with shallower defects excluded | 653 patients treated in the 13 included trials |
| Intervention | Enamel matrix derivative (EMD; Emdogain) for the treatment of intrabony defects | Emdogain (n=9 vs control; n=6 vs GTR; n=1 vs bone graft) |
| Comparison | Placebo or no EMD (same surgical or non-surgical intervention); Guided tissue regeneration (GTR) with barriers; Various types of bone grafting (BG), including animal-derived and synthetic bone | Control/placebo (n=9); Guided tissue regeneration (n=6); Bone graft / bioactive ceramic filler (n=1) |
| Outcomes | Primary: Tooth loss; Change in PAL; Aesthetics; Postoperative complications and other adverse events. Secondary: PAL gain < 2 mm (dichotomous, EMD vs control only); Change in PPD; Change in REC; Change in bone level from the bottom of the defect (BD) relative to the cemento-enamel junction (CEJ) on intraoral radiographs | Tooth loss (n=9); Change in PAL (n=9); Change in PPD (n=9); Change in REC (n=6); Change in marginal bone level (n=3 control, n=1 GTR); Postoperative complications (n=9 control, n=3 GTR); Aesthetics (n=2 control); PAL gain < 2 mm (n=6) |
| Study designs | Randomised controlled clinical trials (RCTs) with at least 1 year follow up | NR |
| Timing | At least 1 year follow up; time-points to be evaluated: 1, 5 and 10 years | One year data (no trial with 5-year follow up) |
Search date: 2009-02. Databases: The Cochrane Oral Health Group Trials Register; The Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE
Questions and results
Current version onlyEnamel matrix derivative (EMD; Emdogain) vs Placebo or control (same surgical or non-surgical intervention without EMD)
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in gingival recession (REC) 1 year (time-points 1, 5 and 10 years planned) | MD 0.02 [-0.3, 0.3] Control flap surgery: mean REC -1.7 to -0.2 mm vs Emdogain 0.02 higher (0.3 lower to 0.3 higher) (less recession) | 6 studies · 302 participants | Low Downgraded: risk of bias, inconsistency |
Change in marginal (radiographic) bone level 1 year (time-points 1, 5 and 10 years planned) | No statistically significant difference between EMD and control for radiographic bone gain (three trials; P effect = 0.27, I2 = 78%). | 3 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (time-points 1, 5 and 10 years planned) | MD 1.08 [0.61, 1.55] Control flap surgery: mean PAL gain 0.8 to 2.2 mm vs Emdogain 1.1 mm higher (0.6 to 1.6 higher) | 9 studies · 371 participants | Low Downgraded: risk of bias, inconsistency |
Change in probing pocket depth (PPD) 1 year (time-points 1, 5 and 10 years planned) | MD 0.88 [0.44, 1.31] Control flap surgery: mean PPD reduction 1.4 to 4.5 mm vs Emdogain 0.7 mm higher (0.5 to 1.0 higher) | 9 studies · 371 participants | Low Downgraded: risk of bias, inconsistency |
Aesthetics 1 year (time-points 1, 5 and 10 years planned) | MD 1.0 [-5.4, 7.4] Control group: mean VAS score 62 vs Emdogain 1.0 higher (5.4 lower to 7.4 higher) | 1 study · 166 participants | Low Downgraded: risk of bias, imprecision |
Tooth loss 1 year (time-points 1, 5 and 10 years planned) | SoF (Emdogain vs Control): Tooth loss - See comment / See comment; too few teeth lost to undertake analysis. 371 participants (9 studies). No GRADE rating given. | 9 studies · 371 participants | Ungraded |
PAL gain < 2 mm (dichotomous) 1 year (time-points 1, 5 and 10 years planned) | RR 0.53 [0.34, 0.82] | 6 studies | Ungraded |
Postoperative complications (infection) / adverse events 1 year (time-points 1, 5 and 10 years planned) | No particular adverse events or infection attributable to EMD in any trial; no differences in pain, edema, hematoma, wound dehiscence or root sensitivity (Tonetti 2002). | 9 studies | Ungraded |
Enamel matrix derivative (EMD; Emdogain) vs Guided tissue regeneration (GTR) with barriers
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in gingival recession (REC) 1 year (time-points 1, 5 and 10 years planned) | MD 0.41 [0.15, 0.66] GTR: mean REC change -1.8 to 1.0 mm vs Emdogain 0.4 mm higher (0.2 to 0.7 higher) (less recession) | 5 studies · 206 participants | Low Downgraded: risk of bias, imprecision |
Tooth loss 1 year (time-points 1, 5 and 10 years planned) | SoF (Emdogain vs GTR): Tooth loss - See comment; too few teeth lost to undertake analysis. 237 participants (5 studies). No GRADE rating given. | 5 studies · 237 participants | Ungraded |
Change in probing pocket depth (PPD) 1 year (time-points 1, 5 and 10 years planned) | MD -0.4 [-1.1, 0.2] GTR: mean PPD reduction 3.3 to 6.5 mm vs Emdogain 0.4 mm lower (0.2 higher to 1.1 lower) | 6 studies · 304 participants | Low Downgraded: risk of bias, imprecision |
Postoperative complications (infection) / adverse events 1 year (time-points 1, 5 and 10 years planned) | RR 0.12 [0.02, 0.85] | 3 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (time-points 1, 5 and 10 years planned) | MD -0.2 [-0.55, 0.20] GTR: mean PAL gain 2.5 to 4.9 mm vs Emdogain 0.2 mm lower (0.2 higher to 0.55 lower) | 6 studies · 304 participants | Low Downgraded: risk of bias, imprecision |
Aesthetics 1 year (time-points 1, 5 and 10 years planned) | SoF (Emdogain vs GTR): Aesthetics - See comment; 0 [0]; No studies reported this. | 0 studies | No studies |
Change in marginal (radiographic) bone level 1 year (time-points 1, 5 and 10 years planned) | No statistically significant differences (one trial). | 1 study | Ungraded |
Enamel matrix derivative (EMD; Emdogain) vs Various bone grafting (BG) procedures (animal-derived or synthetic bone / bioactive ceramic filler)
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in probing attachment level (PAL) 1 year (time-points 1, 5 and 10 years planned) | No statistically significant differences (one trial, Leknes 2009). | 1 study | Ungraded |
Aesthetics 1 year (time-points 1, 5 and 10 years planned) | Aesthetics: no trial evaluated this. | 0 studies | No studies |
Postoperative complications (infection) / adverse events 1 year (time-points 1, 5 and 10 years planned) | Complications and other adverse events: none occurred. | 1 study | Ungraded |
Change in gingival recession (REC) 1 year (time-points 1, 5 and 10 years planned) | MD -1.60 [-2.74, -0.46] | 1 study | Ungraded |
Change in marginal (radiographic) bone level 1 year (time-points 1, 5 and 10 years planned) | Radiographic bone level: no trial evaluated this. | 0 studies | No studies |
Change in probing pocket depth (PPD) 1 year (time-points 1, 5 and 10 years planned) | No statistically significant differences (one trial, Leknes 2009). | 1 study | Ungraded |
Tooth loss 1 year (time-points 1, 5 and 10 years planned) | No teeth were lost in either group. | 1 study | Ungraded |
Enamel matrix derivative (EMD; Emdogain) vs Placebo or control (same surgical or non-surgical intervention without EMD)
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in gingival recession (REC) 1 year (time-points 1, 5 and 10 years planned) | There was no statistically significant difference between EMD and control in REC (five trials; I2 = 60%). | 5 studies | Ungraded |
Tooth loss 1 year (time-points 1, 5 and 10 years planned) | Insufficient numbers of teeth lost to undertake an analysis; all teeth extracted for prosthetic reasons (four test: two Heijl 1997, two Rosing 2005; two control: Heijl 1997). | 8 studies | Ungraded |
Aesthetics 1 year (time-points 1, 5 and 10 years planned) | One trial reported this (Tonetti 2002); no statistically significant difference between EMD and control was found. | 1 study | Ungraded |
Postoperative complications (infection) / adverse events 1 year (time-points 1, 5 and 10 years planned) | No particular adverse events or infection attributable to EMD; no differences in pain, edema, hematoma, wound dehiscence or root sensitivity (Tonetti 2002). | 8 studies | Ungraded |
PAL gain < 2 mm (dichotomous) 1 year (time-points 1, 5 and 10 years planned) | RR 0.48 [0.29, 0.80] | 5 studies | Ungraded |
Change in probing pocket depth (PPD) 1 year (time-points 1, 5 and 10 years planned) | MD 0.77 [0.54, 1.00] | 8 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (time-points 1, 5 and 10 years planned) | MD 1.20 [0.71, 1.69] | 8 studies | Ungraded |
Change in marginal (radiographic) bone level 1 year (time-points 1, 5 and 10 years planned) | There was no statistically significant difference between EMD and control for radiographic bone gain (two trials). | 2 studies | Ungraded |
Enamel matrix derivative (EMD; Emdogain) vs Guided tissue regeneration (GTR) with barriers
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in gingival recession (REC) 1 year (time-points 1, 5 and 10 years planned) | MD 0.39 [0.13, 0.66] | 5 studies | Ungraded |
Tooth loss 1 year (time-points 1, 5 and 10 years planned) | There were no teeth lost in either group in any of these trials. | 5 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (time-points 1, 5 and 10 years planned) | There were no statistically significant differences for PAL (five trials). | 5 studies | Ungraded |
Change in marginal (radiographic) bone level 1 year (time-points 1, 5 and 10 years planned) | Radiographic bone level: there were no trials evaluating this. | 0 studies | No studies |
Change in probing pocket depth (PPD) 1 year (time-points 1, 5 and 10 years planned) | Five trials for this outcome; no statistically significant difference was found. | 5 studies | Ungraded |
Postoperative complications (infection) / adverse events 1 year (time-points 1, 5 and 10 years planned) | RR 0.06 [0.02, 0.24] | 5 studies | Ungraded |
Aesthetics 1 year (time-points 1, 5 and 10 years planned) | No trial evaluated aesthetics. | 0 studies | No studies |
Enamel matrix derivative (EMD; Emdogain) vs Various bone grafting (BG) procedures (animal-derived or synthetic bone / bioactive ceramic filler)
Population: Patients affected by chronic, aggressive, or early onset periodontitis, with intrabony defects having an intrabony component of at least 3 mm
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR 1 year (time-points 1, 5 and 10 years planned) | No trial comparing the use of EMD alone to BG alone was identified. | 0 studies | No studies |
Enamel matrix derivative (EMD; Emdogain) vs Open flap debridement / control flap surgery (placebo vehicle gel in three trials)
Population: Patients affected by periodontitis, with intrabony defects to be treated
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Change in marginal (radiographic) bone level 1 year (18-month data used for one trial) | MD 0.20 [0.88, 3.12] | 1 study | Ungraded |
Tooth loss 1 year (18-month data used for one trial) | There were insufficient numbers of teeth lost to undertake an analysis; all four teeth removed (two control, two test) were extracted for prosthetic reasons (Heijl 1997). | 8 studies | Ungraded |
Postoperative complications (infection) / adverse events 1 year (18-month data used for one trial) | No postoperative infections or other adverse events were reported for either group. | 8 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (18-month data used for one trial) | MD 1.31 [0.84, 1.78] | 8 studies | Ungraded |
Change in gingival recession (REC) 1 year (18-month data used for one trial) | There was no statistically significant difference in gingival recession (REC) between Emdogain and control (six trials). | 6 studies | Ungraded |
Change in probing pocket depth (PPD) 1 year (18-month data used for one trial) | MD 0.96 [0.50, 1.41] | 8 studies | Ungraded |
Aesthetics 1 year (18-month data used for one trial) | In no trials were aesthetic parameters measured. | 0 studies | No studies |
Enamel matrix derivative (EMD; Emdogain) vs Guided tissue regeneration (GTR) with barriers
Population: Patients affected by periodontitis, with intrabony defects to be treated
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Tooth loss 1 year (18-month data used for one trial) | There were no teeth lost in either group in any of these trials. | 6 studies | Ungraded |
Change in gingival recession (REC) 1 year (18-month data used for one trial) | MD 0.47 [0.17, 0.76] | 5 studies | Ungraded |
Change in probing attachment level (PAL) 1 year (18-month data used for one trial) | There were no statistically significant differences for PAL (six trials). | 6 studies | Ungraded |
Postoperative complications (infection) / adverse events 1 year (18-month data used for one trial) | No statistically significant difference in postoperative infections (one trial); the only two postoperative infections occurred in the GTR group. | 1 study | Ungraded |
Change in probing pocket depth (PPD) 1 year (18-month data used for one trial) | MD 0.58 [0.08, 1.07] | 6 studies | Ungraded |
Enamel matrix derivative (EMD; Emdogain) vs Various bone grafting (BG) procedures (animal-derived or synthetic bone / bioactive ceramic filler)
Population: Patients affected by periodontitis, with intrabony defects to be treated
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR 1 year (18-month data used for one trial) | No trial comparing the use of EMD alone to bone grafting procedures alone was identified. | 0 studies | No studies |