Table 1.
Author(s) | Species (initial n/final n) | Teeth (initial n/final n) | Study design | Follow-up | Assessment | Regenerative technique (n sites) | Successful outcome | Comments | Strengths of study | Weaknesses of study |
---|---|---|---|---|---|---|---|---|---|---|
Stassen et al. (1994) | Humans (89/78) | 112/101 | Randomized clinical trial | 27 months | Clinical and radiographic healing | Test: IBBMa (Bio-Oss®) (45); Control (56) | Test: 89%, Control: 64% (p = 0.057) | Randomization of treatment; large sample size per group | No standardization of radiographic evaluation | |
Pecora et al. (1995) | Humans (20/20) | 20/20 | Randomized clinical trial | 6 and 12 months | Clinical and radiographic healing | Test: ePTFEa membrane (Gore-tex®) (10); Control (10) | Test 6 ma: 80%, Test 12 m: 90%, Control 6 m: 20%, Control 12 m: 90% | Randomization of treatment; standardization of radiographic evaluation | Small sample size per group; three different root-end filling materials were used, but not specified | |
Tobon et al. (2002) | Humans (28/25) | 30/26 | Randomized clinical trial | 12 months | Radiographic healing; histology | Test 1: ePTFE membrane (Gore-Tex®) (9); Test 2: resorbable hydroxyapatite (OsteoGen®) and ePTFE membrane (Gore-Text®) (8); Control (9) | Test 1: 77.8%, Test 2: 100%, Control: 88.9% | Histology: Test 1: 62.5% bone, 12.5% scar tissue, 25% granuloma; Test 2: 100% bone; Control: 25% bone, 25% scar tissue, 50% granuloma | Randomization of treatment; study included histology | Small sample size per group; two patients each had two surgical sites; no standardization of radiographic evaluation |
Garrett et al. (2002) | Humans (25/13) | 25/13 | Randomized clinical trial | 3, 6, and 12 months | Radiographic change of densitometric ratio | Test: polylactide membrane (Guidor®) (9); Control (4) | Test 3 m: 0.89, Test 6 m: 0.94, Test 12 m: 0.97, Control 3 m: 0.82, Control 6 m: 0.97, Control 12 m: 0.91 (p > 0.05) | Ratio = density of apical area (region of interest) divided by density of normal bone (region of reference) | Randomization of treatment; standardization of radiographic evaluation | Small sample size per group; root-end filling was not always placed; large drop-out rate (48%) |
Taschieri et al. (2007) | Humans (NAa/NA) | NA/38 | Randomized clinical trial | 12 months | Clinical and radiographic healing | Test: IBBM (Bio-Oss®) and collagen membrane (Bio-Gide®) (16); Control (22) | Test: 87.5%; Control: 81.8% (p N/A) | Data extracted from pooled results of apical and through-and-through lesions | Randomization of treatment | Initial sample size per group not specified; two centers involved; no standardization of radiographic evaluation |
Pantchev et al. (2009) | Humans (131/NA) | 186/147 | Retrospective clinical study | >33 months | Clinical and radiographic healing | Test: Alloplastic glass particulate (PerioGlas®) (68); Control (79) | Test: 73.5%, Control: 83.5% (p > 0.05) | Definition of “uncertain” healing: incomplete but some bone regeneration and presence of some radiolucency | Large study sample | Retrospective study; in many patients, more than one tooth was treated; no standardization of radiographic evaluation; drop-out rate 21% |
Maguire et al. (1998) | Cats (12/12) | 24/24 (maxillary cuspids) | Experimental | 12 weeks | Histology, histomorphometry | Test 1: polylactide membrane (Guidor®) (8); Test 2: osteogenic protein (hOP-1) (8); Control (8) | Test 1: 14.4%, Test 2: 18.4%, Control: 16.6% (percentages = osseous healing within region of interest 1.6 mm apical to resected root end) (p > 0.05) | Root-canal treatments and apical surgeries were performed in same session | Control group; experimental pulpal infection; standardization of defects | Short study period; small sample size per group |
Murashima et al. (2002) | Dogs (11/11) | 22/22 (mandibular premolars #4) | Experimental split-mouth (randomized) | Two subgroups of healing: 8 weeks and 16 weeks | Histology, histomorphometry | Test: Calcium sulfate (Surgiplaster®) (11); Control (11) | Histology at 16 weeks: cortical bone in test sites with little concavity; control sites with obvious concavity. Histomorphometry: bone volume per tissue volume at 16 weeks: Test: 73.0%, Control: 55.6% (p < 0.001) | Root-canal treatment, creation of periapical defects, and apical surgery with root-end filling were all carried out in the same session (this study also assessed through-and-through defects, see Table 2, and apico-marginal defects, see Table 3) | Control group; standardization of defects | Short study period; surgically created defects; different types of lesions tested within same study |
Yoshikawa et al. (2002) | Dogs (12/12) | 48/48 (mandibular premolars #3 and premolars #4) | Experimental, randomized | 4, 8 and 16 weeks (each with four dogs) | Histology, histomorphometry | Test 1: ePTFE membrane (Gore-Tex®) (n N/A); Test 2: PLGAa membrane (product and n N/A); Test 3: collagen membrane (product and n N/A); Test 4: calcium sulfate (Surgiplaster®) (n N/A); Control (n N/A) | Results after 16 weeks: Test 1: 54.8%, Test 2: 21.2%, Test 3: 34.0%, Test 4: 48.9%, Control: 37.4% (percentages = osseous healing of access window) Test 1 better than Test 2 (p < 0.01), Test 3 (p < 0.05) and control (p < 0.05); Test 4 better than Test 2 (p < 0.01) and control (p < 0.05) | Root-canal treatments and apical surgeries were performed in same session | Control group; standardization of defects | Short study period; surgically created defects; sample size per group not specified |
Apaydin and Torabinejad (2004) | Dogs (4/4) | 24/24 (mandibular premolars #2–4) | Experimental, randomized | 16 weeks | Histology, histomorphometry (region of interest 1.6 × 2.2 mm apical of resected root end) | Test: calcium sulfate (Capset®) (12); Control (12) | Test: 54.6%, Control: 53.1% (percentages = bone density in region of interest) | Apical surgeries were performed 2 weeks after root-canal treatment | Control group; split-mouth design; standardization of defects | Short study period; surgically created defects |
Bergenholtz et al. (2006) | Monkeys (6/6) | 48/46 (maxillary and mandibular central and lateral incisors) | Experimental, randomized | 1 month (mandibular incisors); 4.5 months (maxillary incisors) | Radiographs, histology, histometry | Test: rhBMPa-2 (23); Control (23) | No difference in the extent of bone fill or extent and quality of cementum regeneration was observed when comparing test with control | Root-canal treatments and apical surgeries were performed in same session | Control group; split-mouth design; sample size per group; experimental pulpal infection | Short study period; defect size not mentioned; no information about root-end filling material |
Bernabé et al. (2010) | Dogs (6/6) | 48/43 (roots) (mandibular premolars #2–3) | Experimental, comparative (no randomization) | 6 months | Histology Histomorphometry | Test 1: bovine cortical membrane (Gen-Derm®) (n N/A), Test 2: IBBM (Gen-Ox®) (n N/A), Test 3: IBBM (Gen-Ox®) and bovine cortical membrane (Gen-Derm®) (n N/A) Control (n N/A) | No statistically significant differences were noted for inflammatory cell infiltrate and periapical healing when comparing test and control sites | Root-canal treatments and apical surgeries were performed in same session | Control group; experimental pulpal infection; standardization of defects | No randomization of treatment; sample size per group not specified |
IBBM, inorganic bovine bone mineral; ePTFE, expanded polytetrafluoroethylene; NA, not available; PLGA, polylactic-co-glycolic-acid; rhBMP, recombinant human bone morphogenetic protein; m, months; N/A, not available.