| Literature DB >> 31662363 |
Qi Yan1,2, Xinyu Wu1,2, Meiying Su2, Fang Hua3,4, Bin Shi5.
Abstract
OBJECTIVES: To compare the use of short implants (≤6 mm) in atrophic posterior maxilla versus longer implants (≥10 mm) with sinus floor elevation.Entities:
Keywords: short dental implant; sinus floor augmentation; systematic review
Year: 2019 PMID: 31662363 PMCID: PMC6830603 DOI: 10.1136/bmjopen-2019-029826
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1Flow diagram for study selection. RCT, randomised controlled trial.
Characteristics of the included studies
| Study | Design | Subjects | Follow-up period PL | Short implant group | Elevation group | Rehabilitation methods | Outcome measures | |||||||
| Gender | Age | RBH (mm) | Implant (n) | LEN (mm) | DIA (mm) | Implant (n) | LEN (mm) | DIA (mm) | Elevation methods | |||||
| Bolle | RCT (TAP) | INT 7/13 | 59.35 (47–73) | 4–5 | 1 year | 37 | 4 | 4 or 4.5 | 41 | 10, 11.5, 13 | 4 or 4.5 | Osteotomy approach | SG or SP | NIF, MBL, COM |
| Gastaldi | RCT (TAP) | INT 3/17 | 58.6 (39–80) | 4–6 | 3 years | 20 | 5 | 5 | 20 | 10, 11.5, 13, 15 | 5 | Lateral window technique | SG or SP | NIF, MBL, COM |
| Gastaldi | RCT (TAP) | INT 3/7 | 53.4 (43–67) | 5–7 | 3 years | 16 | 5 or 6 | 5 | 18 | 10 | 5 | Osteotomy approach | SG or SP | NIF, MBL, COM, PS |
| Guljé | RCT (TAP) | INT 7/14 | 50 (30–71) | 6–8 | 1 year | 21 | 6 | 4 | 20 | 11 | 4 | Lateral window technique | SG | NIF, MBL, COM, PS |
| Pohl | RCT (TAP) | 49/52* | 50.5 (20–75)*– | 5–7 | 3 years | 67 | 6 | 4 | 70 | 11, 13, 15 | 4 | Lateral window technique | SG | NIF, MBL, COM |
| Felice | RCT (SM) | 11/9 | 57.6 (45–80) | 5–7 | 3 years | 39 | 6 | 4 | 44 | 10, 11.5, 13, 15 | 4 | Lateral window technique | SG or SP | NIF, MBL, COM |
| Bechara | RCT (TAP) | INT 10/23 | 47.5±16.2 | ≥4 | 3 years | 45 | 6 | 4–8 | 45 | 10, 11.5, 13, 15 | 4–8 | Lateral window technique | SG or SP | NIF, MBL, COM, PS |
*Details for subject information in intervention and control group were not reported.
COM, complications; CON, control; DIA, implant diameter; INT, intervention; LEN, implant length; MBL, marginal bone loss; NIF, number of implant failures; NR, not reported; PL, postloading; PS, patient satisfaction;RBH, residual bone width under sinus floor;RCT, randomised controlled trial; SG, single crowns; SM, split mouth; SP, splinted prosthetics; TAP, two arm parallel.
Details on the risk of bias for each included study
| Study | Random sequence generation | Allocation concealment | Blinding of patients/carers | Blinding of outcome assessment | Incomplete outcome data | Selective reporting | Other |
| Bolle | Low risk—quote: ‘a computer-generated restricted randomisation list’ | Low risk-quote: ‘the information on how to treat each patient was enclosed in sequentially numbered, identical, opaque, sealed envelopes.’ | Low risk—quote: ‘treatment allocation was concealed to the investigators in charge of enrolling and treating the patients.’ | High risk—quote: ‘complications were dealt with directly and reported by the responsible clinicians, who were not blinded’; ‘augmented sites could be easily identified on radiographs due to the different implant lengths.’ | Low risk—quote: ‘one patient from the short implant group and one from elevation group dropped out.’ | Low risk—comment; All outcome measure in methods were reported in results | Unclear risk—comment: diameter of implants (4 mm or 4.5 mm) was not controlled |
| Gastaldi | Low risk—quote: ‘a computer-generated restricted randomisation list’ | Low risk—quote: ‘The randomised codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes’ | Low risk—quote: ‘treatment allocation was concealed to the investigators in charge of enrolling and treating the patients.’ | High risk—quote: ‘augmented sites could be easily identified because of the different anatomy of the two sides after the augmentation procedure’ | Low risk—omment: one patient dropped out of the short implant group (1/20), and two patients dropped out of the elevation group (2/20) | Low risk—comment; All outcome measures in methods were reported in results | Unclear risk—comment: information of short implants was not reported |
| Gastaldi | Low risk—quote: ‘a computer-generated restricted randomisation list’ | Low risk—quote: ‘The randomised codes were enclosed in sequentially numbered, identical, opaque, sealed envelopes.’ | Low risk—quote: ‘treatment allocation was concealed to the investigators in charge of enrolling and treating the patients’ | High risk—quote: ‘sinus-lifted sites could be identified on radiographs because they appeared more radio- opaque and implants were longer.’ | High risk—comment: no patients dropped out of the short implant group (0/10); two patients dropped out of the elevation group (2/10) | Low risk—comment; All outcome measures in methods were reported in results | Low risk |
| Guljé | Low risk—quote: ‘Randomisation was performed using a block randomization sequence to provide equal distribution of subjects.’ | Low risk—quote: ‘A sealed envelope’ | Low risk—quote: ‘A sealed envelope was opened by the surgical assistant at the beginning of the surgical procedure.’ | High risk—quote: ‘blinding was possible in the clinical evaluation but not during analysis of the radiographs.’ | Low risk—comment: no patient dropped out of the short implant group (0/21); one patient in the elevation group died (1/20) | Low risk—omment; All outcome measures in methods were reported in results | Low risk |
| Pohl | Low risk—quote: ‘A block randomization sequence was used to provide an equal distribution’ | Low risk—quote: ‘A sealed envelope’ | Low risk—quote: ‘After flap elevation, a sealed randomisation envelope was opened to allocate the subject to either one of the two treatment groups.’ | Unclear risk—quote: ‘an independent examiner performed all the radiographic measurements.’ Other information was not reported. | High risk—comment: The reasons for incomplete reporting of MBL were not provided. | High risk—comment: MBL at 3-year follow-up was reported at the implant level rather than at the participant level | Low risk |
| Felice | Low risk—quote: ‘a computer-generated restricted randomisation list’ | Low risk—quote: ‘The information on how to treat site number one was enclosed in sequentially numbered, identical, opaque, sealed envelopes.’ | Low risk—quote: ‘Treatment allocation was concealed to the investigators in charge of enrolling and treating the patients.’ | High risk—quote: ‘augmented sites could be easily identified because of the different anatomy’ | High risk—comment: it was a split-mouth design study, and two drop-outs (2/20) occurred | Low risk—comment: All outcome measures in methods were reported in results | Low risk |
| Bechara | Unclear risk—quote: ‘Patients were randomly assigned’ | Low risk—quote: ‘a sequentially numbered sealed envelope’ | Unclear risk—comment: not mentioned | Unclear risk—quote: ‘At each annual inspection, an experienced, calibrated, independent examiner performed a careful clinical examination’, but elevation site can be distinguished | Low risk—comment: one patient dropped out of the short implant group (1/33), and one patient dropped out of the elevation group (1/20) | High risk—comment: MBL was reported at the implant level rather than at the participant level | High risk—comment: diameter of implants was not controlled (4–8 mm) |
MBL, marginal bone loss.
Figure 4Forest plot for implant survival rate. M-H, Mantel-Haenszel; SI, short implant group; SFE, sinus floor elevation group.
Details of implant failures reported in the included studies
| Study | Short implant group | Elevation group | ||||||
| LEN (mm) | DIA (mm) | PAR/IMP (n) | Details | LEN (mm) | DIA (mm) | PAR/IMP (n) | Details | |
| Bolle | 4 | 4 or 4.5 | 2/3 | PAR1. One implant was mobile 3 months after placement, and another implant migrated into the sinus 4 months after placement. PAR2. One implant was medially tilted 2 weeks after placement | 10,11.5,13 | 4 or 4.5 | 4/6 | PAR1. One implant was mobile 2 months after placement because of a perforation of the sinus lining at its detachment. Another implant was mobile 2 months later. PAR2. One implant migrated into the sinus 3 months after placement. PAR3. Two implants were mobile 3 months after placement because the patient insisted on wearing her removable denture. PAR4. One implant was mobile, and the patient experienced discomfort when chewing 5 months postloading. |
| Gastaldi | 5 | 5 | 1/1 | PAR1. One implant failed 3 months postloading. | 10,11.5, 13,15 | 5 | 0 | None |
| Felice | 6 | 4 | 0 | None | 10,11.5, 13,15 | 4 | 1/2 | PAR1. Two implants failed due to peri-implantitis 2 years postloading. |
| Bechara | 6 | 4–8 | 0 | None | 10,11.5, 13,15 | 4–8 | 1/2 | PAR1. Two implants were lost caused due to chronic sinus infection with loss of integration/implant stability 2 months after surgery. |
DIA, implant diameter;LEN, implant length; PAR, participant; PAR/IMP, participant/implant.
Figure 5Forest plot for marginal bone loss. SI, short implant group; SFE, sinus floor elevation group.
Comparisons of complications
| Outcome or subgroup titles | No of studies | No of participants | Statistical methods | Effect size |
| Postsurgery reaction | 3 | 184 | Risk ratio (Fixed, M-H, 95% CI) | 0.11 (0.14 to 0.31)* |
| Biological complications | ||||
| Sinus perforation or infection | 3 | 125 | Risk ratio (Fixed, M-H, 95% CI) | 0.11 (0.02 to 0.63)* |
| Implant mobile | 2 | 132 | Risk ratio (Fixed, M-H, 95% CI) | 0.34 (0.06 to 2.06) |
| Peri-implant mucositis and peri-implantitis | 2 | 54 | Risk ratio (Fixed, M-H, 95% CI) | 0.91 (0.14 to 5.79) |
| Technical complications | Risk ratio (Fixed, M-H, 95% CI) | |||
| Screw loosening | 3 | 169 | Risk ratio (Fixed, M-H, 95% CI) | 2.66 (0.93 to 7.60) |
| Crown loosening, decementation or chipping | 5 | 223 | Risk ratio (Random, M-H, 95% CI) | 1.22 (0.33 to 4.49) |
*Difference between the two groups was significant.
M-H, Mantel-Haenszel.
Summary of findings
| Short implant (≤6 mm) compared with longer implant (≥10 mm) with sinus floor elevation in atrophic posterior maxilla | ||||||
|
| ||||||
| Outcomes |
| Relative effect | № of participants | Certainty of the evidence | Comments | |
| Assumed risk† (elevation group) | Corresponding risk | |||||
| Survival rate follow-up: range 1–3 years | 961 per 1000 |
|
| 321 | ⨁⨁⨁◯ | |
| Survival rate follow-up: range 3 years to longer years | 982 per 1000 |
|
| 237 | ⨁⨁⨁◯ | |
| Marginal bone loss follow-up: range 1–3 years | The mean marginal bone loss ranged from | The mean marginal bone loss in the intervention group was 0.13 mm lower (0.21 lower to 0.05 lower) | – | 249 | ⨁⨁◯◯ | |
| Marginal bone loss follow-up: range 3 years to longer years | The mean marginal bone loss ranged from | The mean marginal bone loss in the intervention group was 0.25 mm lower (0.4 lower to 0.1 lower) | – | 88 | ⨁⨁⨁◯ | |
| Postsurgery reaction | 307 per 1000 |
|
| 184 | ⨁⨁⨁◯ | |
| Biological complications: sinus perforation or infection | 197 per 1000 |
|
| 125 | ⨁⨁◯◯ | |
| Biological complications: implant mobile | 59 per 1000 |
|
| 132 | ⨁⨁◯◯ | |
| Biological complications: peri-implant mucositis or peri-implantitis | 200 per 1000 |
|
| 54 | ⨁⨁◯◯ | |
| Technical complications: screw loosening | 81 per 1000 |
|
| 169 | ⨁⨁◯◯ | |
| Technical complications: crown loosening, decementation and chipping | 27 per 1000 |
|
| 223 | ⨁⨁◯◯ | |
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
†Assumed risk is based on the overall event rate in the control groups of the included studies.
‡Downgraded one level due to serious risks of bias.
§Downgraded two levels due to serious risks of bias and serious inconsistency.
¶Downgraded two levels due to serious risks of bias and imprecision.
GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCTs, randomised controlled trials; RR, risk ratio.