Background
Materials and methods
Protocol and eligibility criteria
Information sources and literature search
Data collection and extraction
Risk of bias assessment
Synthesis of results
Results
Study selection
Study (year) | Study no. | Study design | No. of patients (m/f, age) | Test group | Control group | Treatment indication | Follow up period (months) | Loss to follow-up/training purpose (n) | |||
---|---|---|---|---|---|---|---|---|---|---|---|
Smoking status | Product (no. of sites) | Graft widtha
Graft lengthb
| No. of layers (no. of patients) | Type of graft (no. of sites) | Graft widtha
Graft lengthb (no. of patients) | ||||||
Acellular matrices | |||||||||||
Wei et al. (2000) [17] | I | (R)CT | 12 (7/5, range 25–79) NS | AD (6) | 8.4–9.67 mm NR | 1 | FGG (6) | 5.67–8.00 mm NR | Insufficient zone of AG (≤1 mm) | 6 | 0/0 |
Harris (2001) [10] | II | (R)CT | 45 (18/27, range 14–67) NR | AD (15) | NR | 1 | Control 1: FGG (15) Control 2: CTG (15) | NR NR | Insufficient zone of KT | 3 | 0/0 |
Nevins et al. (2010) [15] | III | (R)CT, SM | 6 (1/5, mean 41) NR | DM (6) | NR | 1 (5) 2 (1) | FGG (6) | NR | Insufficient zone of AG (≤2 mm) | 3 | 0/0 |
Nevins et al. (2011) [16] | IV | (R)CT, SM | 5 (NR, range 20–70) NR | MG (5) | NR | 1 | FGG (5) | NR | Insufficient zone of AG (≤2 mm) | 12 | 0/0 |
McGuire & Scheyer (2014) [14] | V | RCT, SM | 30 (6/24, range 28.1–70.6) NS and FS (since at least 6 months) | MG (30) | “As widely as possible” NR | 1 | FGG (30) | 4 mm NR | Insufficient zone of KT (<2 mm) | 6 | 0/0 |
Tissue-engineered STSs | |||||||||||
McGuire & Nunn (2005) [11] | VI | RCT, SM | 25 (9/16, range 27–56.5) 16 NS, 9 FS | DG (25) | 5 mm NR | 1 (5) 3 (15) 4 (2) | FGG (25) | 5 NR | Insufficient zone of AG | 12 | 0/3 |
McGuire et al. (2008) [12] | VII | RCT, SM | 25 (8/17, range 31.1–69.7) 14 NS, 11 FS | CT (25) | 5 mm NR | 3 | FGG (25) | 5 NR | Insufficient zone of AG (≤1 mm) | 6 | 0/0 |
McGuire et al. (2011) [13] | VIII | RCT, SM | 96 (39/46, range 18.0–70.8) NS and FS (since at least 3 months) | CT (96) | 5–20 mm 10–30 mm | 3 | FGG (96) | 4 mm (94) 5 mm (2) 8–30 mm | Insufficient zone of AG (≤1 mm) | 6 | 0/11 |
Study characteristics
Study populations
Type of intervention
Type of autogenous soft tissue grafts and STSs
Product name | Origin of the material | Company | Product sold in | Adverse events |
---|---|---|---|---|
Acellular matrices | ||||
AlloDerm® | Human freeze-dried, cell-free, dermal matrix | LifeCell Corp., Branchburg, NJ, USA | USA, distributed in the EU via HTA | None |
DynaMatrix® | Porcine small intestinal submucosa (collagens, glycosaminoglycans, glycoproteins, proteoglycans, growth factors) | Keystone Dental, Turnpike Burlington, MA, USA | USA and Europe since 2008 | None |
Mucograft® | Porcine bilayer collagen matrix | Geistlich Pharma, Wolhusen, Switzerland | USA and EMEA since 2010 | None |
Tissue engineered | ||||
CelTx™ (Apligraf®) | Living cellular construct composed of human fibroblasts, keratinocytes, and extracellular matrix proteins on type I bovine collagen | Organogenesis, Canton, MA, USA | FDA approved, but not distributed for dental use | 24 patients reported >1 adverse event (total of 43 events, no event reported by >2 patients); 3 patients reported adverse events at LCC site (McGuire et al. 2011) [13] |
Dermagraft® | Living human fibroblast-derived dermal substitute | Advanced Tissue Sciences, Inc., La Jolla, CA, USA | Withdrawn from the market | None |
Type of reported outcome variables
Study (year) | Group | Baseline (mm) | Final evaluation | Graft contraction (%) | Frequency of postintervention KT width ≥2 mm (range or 95% CI of postintervention KT width) | |||
---|---|---|---|---|---|---|---|---|
Values (mm) | Gain (mm) | Mean difference in gain (mm) | Comparison based on | |||||
Acellular matrices | ||||||||
Wei et al. (2000) [17] | Test | 0.68 ± 0.26a
|
3.25 ± 0.89
a
|
2.59 ± 0.92
a
| 2.98c
|
A, B, C
|
71 ± 10
a
| NR |
Control | 0.57 ± 0.41a
|
6.15 ± 0.49
a
|
5.57 ± 0.44
a
|
16 ± 12
a
| NR | |||
Harris (2001) [10] | Test | 0.6 ± 0.87a
|
4.7 ± 1.92
a
| 4.1 ± 1.79a
|
A, C | NR | <100% (range 1.5–8.5 mm) | |
Control (FGG) | 0.8 ± 0.59a
|
4.8 ± 1.16
a
| 4.1 ± 1.25a
| 0.00c
| 100% (range 3.0–6.5 mm) | |||
Control (CTG) | 0.4 ± 0.47a
|
4.0 ± 0.99
a
| 3.6 ± 0.82a
| 0.50c
| 100% (range 2.5–5.5 mm) | |||
Nevins et al. (2010) [15] | Test | 0.8 ± 0.7a
|
3.4 ± 0.8
a
|
2.6 ± 1.1
a
| 2.7c
|
A, C
| NR | 100% (range 2.5–5.0 mm) |
Control | 1.1 ± 1.1a
|
6.4 ± 0.9
a
|
5.3 ± 1.3
a
| 100% (range 5.0–8.0 mm) | ||||
Nevins et al. (2011) [16] | Test | NR |
NR
| 2.3 ± 1.1a
| 0.80c
|
A, C | NR | NR |
Control | NR |
NR
| 3.1 ± 0.6a
| NR | ||||
McGuire & Scheyer (2014) [14] | Test | 0.88 ± 0.61a
|
2.92 ± 0.88
a
|
2.04
c
| 1.61c
|
B, C
| NR | 96.67% (95% CI 2.59–3.25 mm) |
Control | 0.77 ± 0.68a
|
4.42 ± 0.64
a
|
3.65
c
| NR (95% CI 4.18–4.66 mm) | ||||
Tissue engineered | ||||||||
McGuire & Nunn (2005) [11] | Test | 1.46 ± 0.91a
|
2.72 (2.42–3.03)b
| 1.26c
| 1.31c
|
B
|
45.5 (39.5–51.4)b
| NR (95% CI 2.42–3.03 mm) |
Control | 1.34 ± 0.97a
|
3.91 (3.61–4.22)b
| 2.57c
|
21.8 (15.9–27.7)b
| NR (95% CI 3.61–4.22 mm) | |||
McGuire et al. (2008) [12] | Test | 1.07 (0.89–1.25)b
|
2.40 (2.08–2.72)b
|
1.33 (0.95–1.71)b
| 1.96c
|
A, B, C
| NR | 76% (95% CI 2.08–2.72 mm) |
Control | 1.17 (0.99–1.35)b
|
4.46 (4.14–4.78)b
|
3.29 (2.91–3.68)b
| 100% (95% CI 4.14–4.78 mm) | ||||
McGuire et al. (2011) [13] | Test | 1.41 ± 0.72a
|
3.21 ± 1.14
a
| 1.80c
| 1.34c
|
B
| NR | 95.3% (NR) |
Control | 1.43 ± 0.69a
|
4.57 ± 1.00
a
| 3.14c
| NR |
Study (year) | Group | Tissue color | Tissue texture | ||||
---|---|---|---|---|---|---|---|
Less | Equally | More | Less | Equally | More | ||
Red (%) | Firm (%) | ||||||
McGuire & Nunn (2005)a [11] | STS |
9.1
|
90.9
|
0.0
|
9.1
|
90.9
|
0.0
|
FGG |
68.2
|
27.3
|
4.6
|
77.3
|
22.7
|
0.0
| |
McGuire et al. (2011)b [13] | STS |
2.4
|
92.9
|
4.7
|
0.0
|
95.3
|
4.7
|
FGG |
72.9
|
27.1
|
0.0
|
45.9
|
54.1
|
0.0
| |
Match to neighboring tissue (%) | |||||||
McGuire & Scheyer (2014) [14] | STS |
87
|
97
| ||||
FGG |
10
|
0
| |||||
Authors’ description of the STS groupc
| |||||||
Wei et al. (2000) [17] | “Appears similar to the alveolar mucosa” | “Appears similar to the alveolar mucosa” | |||||
Harris et al. (2001) [10] | NR | “CTG and AD seemed to produce a more aesthetic result in most cases; however, both produced a result that was as ‘patch like’ in appearance as a FGG” | |||||
McGuire et al. (2008) [12] | “Significant better matching” | “Significant better matching” | |||||
Nevins et al. (2010) [15] | “Excellent color blend” | “Excellent texture blend” | |||||
Nevins et al. (2011) [16] | “Excellent color blend” | “Excellent texture blend” |
Study (year) | Group | Pain level | Patient preference/satisfaction | |||
---|---|---|---|---|---|---|
None (%) | Mild (%) | Moderate (%) | Severe (%) | |||
McGuire & Nunn (2005)a [11] | STS | 13.6 | 50.0 | 31.8 | 4.6 | 9.91 ± 1.54b
|
FGG | 13.6 | 54.6 | 27.3 | 4.6 | 10.20 ± 1.13b
| |
After 3 days (%) | After 7 days (%) | |||||
McGuire et al. (2011)c [13] | STS | 70.6 | 45.9 |
76.5%
| ||
FGG | 62.3 | 37.7 |
23.5%
| |||
Authors’ descriptiond
| ||||||
Harris (2001) [10] | STS | “Higher pain levels in the FGG group from the donor site... These patients tended to take more pain medication and for a longer period of time.” | NR | |||
FGG | ||||||
CTG | ||||||
McGuire et al. (2008) [12] | STS | “Subject perception of the duration of pain was reduced in the STS sites.” |
60%
| |||
FGG |
20% (no preference 20%) | |||||
Nevins et al. (2010) [15] | STS | “Patients reported less discomfort related to the palatal harvest with the DynaMatrix when compared to the autogenous sites.” | NR | |||
FGG | ||||||
McGuire & Scheyer (2014) [14] | STS | NR |
70%
| |||
FGG |
30%
| |||||
Nevins et al. (2011) [16] | STS | NR | Authors’ descriptiond
| |||
FGG | “Significant bias toward avoiding palatal harvesting, in favor of the STS group” | |||||
Wei et al. (2000) [17] | STS | NR | NR | |||
FGG |
Results on KT width
Results on PROMs
Synthesis of results
KT width
Graft contraction
Tissue color and texture match (Fig. 2a, b)
Patient preference (Fig. 2c)
RoB assessment
Discussion
-
No preclinical in vivo studies comparing autogenous soft tissue grafts with a STS material are available.
-
Use of STSs (acellular matrix or tissue engineered) in combination with APF resulted in a significantly less gain of KT width compared to what achieved with FGG and APF.
-
Use of a tissue-engineered STS was apparently not superior to the use of an acellular matrix.
-
Use of STS does not predictably result in a KT width ≥2 mm after treatment, while use of FGG does.
-
Significantly better aesthetic outcomes and larger patient preference in favor of STS were observed.
-
STS materials appeared to be safe.