Cochrane · intervention · CD006204
Resorbable versus titanium plates for orthognathic surgery
Agnihotry, A, Fedorowicz, Z, Nasser, M, et al. · Cochrane Database of Systematic Reviews · 2017 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
19
current version
GRADE rated
5
No studies
6
Included studies
2
as reported
No studies 6 · 31.6%Ungraded 8 · 42.1%Very low 5 · 26.3%Low 0 · 0%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 | Adults (>16 years old) undergoing orthognathic surgery; fracture patients excluded | 103 participants across 2 RCTs. Cheung 2004 (Hong Kong, China): 60 adults (18 male, 42 female), 16 to 37 years (mean 22.9), with dentofacial deformities. Weidner 2005 (Germany): 43 of 60 adults (27 female, 16 male) undergoing mandibular setback/advancement. |
| Intervention | Bioresorbable (resorbable) plates or screws or both | Resorbable plates (BiosorbFX self-reinforced poly-L/DL lactic acid copolymer) (n=30); Resorbable screws (Isosorb, biodegradable lactopolymer) (n=23) |
| Comparison | Titanium plates or screws (used as lag screws) or both | Titanium plates (Compact 2.0 pure titanium plating system) (n=30); Titanium screws (Stryker-Leibinger) (n=20) |
| Outcomes | Need for retreatment or replacement of fixation; Status of occlusion (ANB/Angle's/Wits); Facial appearance and profile; Immediate postoperative swelling; Degree of function postoperatively; Satisfactory radiographic appearance; Postoperative pain (VAS); Analgesic medication used; Quality of life; Patient satisfaction; Costs; Adverse effects (insufficient fixation, re-operation/revision, plate exposure, dislocation, non-union, superficial/deep wound infection, sinus tract, wound dehiscence, blood loss, thromboembolic complications, any medical complication, persistent pain, loss of sensation/function, foreign body/inflammatory reaction, post-traumatic dystrophy) | Need for retreatment/replacement of fixation (n=60); Clinical stability of osteotomy segments (n=60); Status of occlusion/ANB (n=43); Immediate postoperative swelling (n=60); Postoperative pain immediate recovery period (n=60); Postoperative chronic or lasting pain (n=60); Patient satisfaction (n=60); Plate exposure (n=60); Superficial and deep wound infection (n=60); Occurrence of sinus tract (n=60); Wound dehiscence (n=60); Re-operation and revision rate/plate removal (n=60) |
| Study designs | Randomised controlled trials (RCTs) | 2 RCTs (Cheung 2004, Weidner 2005), both at high overall risk of bias (high risk of performance and detection bias; blinding not feasible as metal is easily distinguished from resorbable plates) |
| Timing | Follow-up up to 3 years postoperatively | Cheung 2004 followed up at 2 weeks, 6 weeks, 3, 6, 12 and 24 months; Weidner 2005 at six intervals from before orthodontic treatment to 15 months postoperatively |
Search date: 2017-01. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform
Questions and results
Show all 3 versionsResorbable (bioresorbable) plates or screws for fixation vs Titanium plates or screws for fixation
Population: Adults (>16 years old) undergoing orthognathic surgery
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Exposure of the plate (adverse effect) Up to 3 years postoperatively | Both titanium and resorbable groups experienced two plate exposures which occurred between the third and ninth month, with plate exposure rates of 1.02% for the titanium group and 1.21% for the resorbable group. All… | 1 study · 60 participants | Ungraded |
Wound dehiscence (adverse effect) Up to 3 years postoperatively | Three patients (10%) in the titanium group and two patients (6.7%) in the resorbable group presented with wound dehiscence. One patient in each group with dehisced wounds became infected; all non-infected wounds closed… | 1 study · 60 participants | Ungraded |
Clinical stability of osteotomy segments (VAS 0 to 10) 0 to 24 months (by period) | Clinical stability of osteotomy segments (Cheung 2004), self-assessed on a VAS (0=very mobile, 10=no mobility) by postoperative period, titanium vs resorbable mean (SD): 0 to 2 weeks 8.10 (1.79) vs 8.47 (2.18), P=0.48;… | 1 study · 60 participants | Ungraded |
Patient satisfaction (VAS 0 to 10) 4 to 6 months | MD 0.17 [-0.67, 1.01] | 1 study · 60 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Facial appearance and profile Up to 3 years postoperatively | No data available for this outcome. | 0 studies | No studies |
Need for retreatment or replacement of fixation due to failure of the fixation Mean 1 year | SoF row (Resorbable plates compared to titanium plates for stabilization after orthognathic surgery). Need for retreatment or replacement of fixation due to failure of the fixation (plates failed or removed in each… | 1 study · 60 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Postoperative chronic or lasting pain (wound discomfort) at 4 to 6 months (VAS 0 to 10) 4 to 6 months | MD -0.77 [-1.58, 0.04] | 1 study · 60 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Analgesic medication used (type, dose, frequency) Up to 3 years postoperatively | No data available for this outcome. | 0 studies | No studies |
Occurrence of sinus tract (adverse effect) Up to 3 years postoperatively | Five patients (three in the titanium group and two in the resorbable group) developed a non-infected sinus tract. The sinus tracts arose earlier in the titanium group (sixth week) than in the resorbable group (third… | 1 study · 60 participants | Ungraded |
Postoperative pain during the immediate recovery period (VAS 0 to 10) 2 weeks (immediate recovery period) | MD -0.77 [-1.92, 0.38] | 1 study · 60 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Costs (fixation materials, hospital bed days, retreatment) Up to 3 years postoperatively | None of the studies reported on the cost incurred in the treatment. | 0 studies | No studies |
Re-operation and revision rate / plate removal (adverse effect) Up to 3 years postoperatively | Plate removal rates were 1.53% (3/196) of the titanium plates and 3.63% (6/165) of the resorbable ones. Out of a total of nine, two in each group were removed because of plate exposure, one patient in the titanium and… | 1 study · 60 participants | Ungraded |
Status of occlusion (e.g. ANB, Angle's classification, Wits analysis) Up to 3 years postoperatively | Weidner 2005 provided analyses of mean changes in ANB from scanned radiographs. The ANB data were incomplete for many of the five time periods and were reported as 'grad' rather than the conventionally accepted… | 1 study · 43 participants | Ungraded |
Immediate postoperative swelling (assessed by photography or digital morphometry) Up to 3 years postoperatively | Though Cheung 2004 reported the presence of postoperative swelling, it was only noted in conjunction with infection and pus discharge; assessment of this outcome did not include the use of photography or digital… | 1 study · 60 participants | Ungraded |
Quality of life Up to 3 years postoperatively | None of the included studies reported this outcome. | 0 studies | No studies |
Adverse effects (composite: plate exposure, wound infection, sinus tract, wound dehiscence, plate removal) Up to 24 months postoperatively | SoF row. Adverse effects; 60 participants (1 RCT); Quality of the evidence (GRADE): VERY LOW. Exposure of the plate: both titanium and resorbable groups experienced 2 plate exposures which occurred between the third… | 1 study · 60 participants | Very low Downgraded: risk of bias, inconsistency, indirectness |
Superficial and deep wound infection (adverse effect) Up to 3 years postoperatively | The trialists did not differentiate between superficial and deep wound infection. Three (10%) of the patients in each group developed infections accounting for six plates: 3/196 (1.53%) in the titanium group and 3/165… | 1 study · 60 participants | Ungraded |
Degree of function postoperatively (mastication, swallowing, speech) Up to 3 years postoperatively | No data available for this outcome. | 0 studies | No studies |
Satisfactory radiographic appearance (cephalometric radiographs) Up to 3 years postoperatively | No data available for this outcome. | 0 studies | No studies |