Cochrane · intervention · CD006087
Interventions for the management of mandibular fractures
Nasser, M, Pandis, N, Fleming, PS, et al. · Cochrane Database of Systematic Reviews · 2013 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
42
current version
GRADE rated
0
No studies
1
Included studies
12
as reported
No studies 1 · 2.4%Ungraded 41 · 97.6%Very low 0 · 0%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 with mandibular fractures excluding unilateral or bilateral condylar involvement; initially subjects over 18 years, threshold reduced to 16 years (adults usually defined as over 16 within health services) | 689 participants aged 16 to 68 years with 830 fracture sites (618 males, 51 females in 11 studies); fracture sites: angle 63.3%, parasymphysis 21.0%, body 6.6%, symphysis 2.0%, other 7.1% |
| Intervention | Any form of open or closed reduction and fixation (excluding intentional fractures for orthognathic surgery or tumour resection) | 2 mm locking titanium plates (n=2); 2 mm titanium plates (n=1); two lag screws (n=1); 3D miniplates (n=2); one microplate + one miniplate (n=1); immediate mobilization (n=1); intraoperative Rapid IMF (n=1); two miniplates transbuccal (n=2); transbuccal + intraoral approach (n=1) |
| Comparison | Studies that compared any two or more methods of management of mandibular fractures | 2 mm non-locking titanium plates (n=2); 2.5 mm bioresorbable plates (n=1); one lag screw (n=1); standard Champy plates (n=2); two miniplates (n=1); 2 weeks delayed mobilization (n=1); eyelet wire ties (n=1); one miniplate + two screws (n=2); intraoral alone approach (n=1) |
| Outcomes | Patient-oriented: restoration of function (chewing, swallowing, speech, denture wearing); facial appearance (profile, symmetry, scarring); impact on well-being and quality of life. Clinical: requirement for additional (surgical/non-surgical) interventions; post-operative pain; post-operative adverse events and complications. Process (secondary): intraoperative complications; drop-out rate due to protocol deviation | Restoration of function (n=7); facial appearance (n=2); quality of life (n=0); requirement for additional interventions (n=7); post-operative pain (n=4); post-operative adverse events and complications (n=11); intraoperative complications (n=3); drop-out rate due to protocol deviation (n=1) |
| Study designs | Only randomised controlled trials (RCTs) | 12 RCTs (six high risk of bias, six unclear risk of bias) |
| Timing | Follow-up varied from 1 week to 6 months | Study end-points 1 week to 6 months: 1 week to 2 months (n=1); 6 weeks (n=1); 2 months (n=2); 3 months (n=4); 6 months (n=3); intraoperative period only (n=1) |
Search date: 2013-02. Databases: Cochrane Oral Health Group's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via OVID; EMBASE via OVID
Questions and results
Show all 3 versions2 mm locking titanium plates vs 2 mm non-locking titanium plates
Population: Adults (16 to 68 years) with mandibular fractures excluding condylar involvement
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Requirement for additional (surgical) interventions | Only Collins 2004 provided data: 6/122 participants had minor complications (three in each group); five required surgical removal of the locking plates and one post-operative malocclusion was managed with elastic… | 1 study · 122 participants | Ungraded |
Post-operative adverse events and complications (paraesthesia, swelling, segmental mobility) | Agarwal 2011: paraesthesia in one participant in the non-locking plate group (resolved by 3 months), none in the locking group; infection rates similar at 6 weeks and 3 months; post-operative swelling in 20% of both… | 1 study | Ungraded |
Post-operative pain | Agarwal 2011 reported a significant decrease in VAS pain from week 1 to the 3-month follow-up, with no difference between groups at the follow-up visits, but presented no supporting data. | 1 study | Ungraded |
Drop-out rate due to protocol deviation | Early premature removal of IMF (from hours up to 2 weeks) was reported in 13 of the 90 participants analysed (Collins 2004); participants released their own IMF or reported that "the wires fell off". | 1 study · 90 participants | Ungraded |
Restoration of function (functional occlusion; bite force as surrogate) | Functional occlusion was achieved in all participants in both intervention groups (Agarwal 2011); the measurement of this outcome was not clearly reported. Bite force was reported as a surrogate/proxy outcome. | 1 study | Ungraded |
Post-operative infection | OR 0.90 [0.1, 7] | 1 study | Ungraded |
2 mm titanium plates vs 2.5 mm bioresorbable plates
Population: Adults (16 to 68 years) with mandibular fractures excluding condylar involvement
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Chronic infection 1 month | Chronic infection per site 1/32 (3.1%) titanium vs 0/25 resorbable (RD -3.1%); higher in the titanium group. No risk ratio estimable. -3.1 percentage points (RD) | 1 study · 57 participants | Ungraded |
Wound dehiscence First few weeks (immediate) | RR 2.13 [0.56, 8.08] 10.6 [-8.0, 29.3] percentage points (RD) | 1 study · 57 participants | Ungraded |
Restoration of function (inability to chew hard food) 1 month | RR 1.0 [0.23, 4.27] | 1 study · 34 participants | Ungraded |
Post-operative neurosensory disturbance (mental nerve paraesthesia) 1 month | RR 1.77 [1.09, 2.88] 31.4 [6.9, 55.8] percentage points (RD, resorbable vs titanium) | 1 study · 57 participants | Ungraded |
Malocclusion 1 month | RR 1.1 [0.32, 3.82] 2.0 [-22.9, 26.9] percentage points (RD) | 1 study · 40 participants | Ungraded |
Requirement for additional (surgical) interventions (plate removal / re-operation) | Plate removal was statistically more likely in the titanium group (Fisher's exact P<0.05); infection led to plate removal in one titanium participant at 2 months and a further 4/21 (19%) titanium participants (six… | 1 study | Ungraded |
Moderate soft tissue deformity 1 month | RR 6.4 [0.80, 51.3] 12.5 [0.08, 33.7] percentage points (RD) | 1 study · 57 participants | Ungraded |
Post-operative pain (residual pain, any severity) 1 month | RR 1.26 [0.57, 2.82] | 1 study · 40 participants | Ungraded |
Segmental mobility 1 month | RR 3.84 [0.85, 17.4] 17.8 [-0.1, 36.5] percentage points (RD) | 1 study · 57 participants | Ungraded |
Two lag screws vs One lag screw (with arch bars and IMF)
Population: Adults (16 to 68 years) with mandibular fractures excluding condylar involvement
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Post-operative pain (average VAS score) | Average pain scores (scale 1 to 10): week 1, 6.6 (two lag screws) vs 6.4 (one lag screw); after 2 weeks, 2.5 vs 2.1. Confidence intervals were not reported. | 1 study | Ungraded |
Restoration of function (occlusion) | Restoration of the original occlusion, assessed visually, was similar in both groups (P>0.05); occlusal correction was not achieved in one participant in the two-lag-screws group. Surrogate/proxy outcome. | 1 study | Ungraded |
Post-operative adverse events and complications | Three participants in the two-lag-screws group experienced complications: malocclusion (one) and mental-nerve paraesthesia (two, resolved after 3 months). There were no post-operative complications in the one-lag-screw… | 1 study | Ungraded |
Intraoperative complications | Drill-bit fracture occurred during preparation in one participant in the two-lag-screws group. | 1 study | Ungraded |
3-dimensional (3D) miniplates vs Standard (Champy) plates
Population: Adults (16 to 68 years) with mandibular fractures excluding condylar involvement
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Requirement for additional (surgical) interventions (post-operative MMF/IMF) | RR 0.47 [0.25, 0.88] | 1 study · 50 participants | Ungraded |
Restoration of function (occlusion) | All participants in both groups in Jain 2010 had "satisfactory post-operative occlusion"; it is unclear whether a validated tool was used. | 1 study | Ungraded |
Post-operative adverse events and complications | Jain 2010 (3D group): segmental mobility (two), proximity to mental nerve or roots (two), radiologically unsatisfactory reduction (one) and unsatisfactory fixation (four) vs one (standard); only fixation differed… | 2 studies | Ungraded |
Post-operative infection | RR 1.26 [0.19, 8.13] | 2 studies · 90 participants | Ungraded |
Post-operative pain | Singh 2012 evaluated VAS pain at weeks 1, 4, 8 and month 3 and reported no significant difference between the groups, without supporting details. | 1 study | Ungraded |
Immediate mobilization vs 2 weeks delayed mobilization (IMF)
Population: Adults with mandibular fractures excluding condyles (fixed with 2 mm titanium miniplates)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Post-operative pain | Pain (scale 1 to 10) was minor in both groups with no significant differences (Table 4): 6 weeks 1.55 vs 1.20; 3 months 1.00 vs 2.64; 6 months 1.30 vs 2.71 (immediate release vs IMF). 95% confidence interval not… | 1 study | Ungraded |
Post-operative adverse events and complications | One wound separation and one infection in the immediate-mobilization group. Inferior alveolar nerve status (scale 1 to 3) showed no significant difference at 6 weeks (P=0.76), 3 months (P=0.87) or 6 months (P=0.99).… | 1 study | Ungraded |
Requirement for additional (surgical) interventions | In the IMF (delayed) group, one participant (7.7%) had a wound infection and plate exposure leading to plate removal 4 months post-operatively. | 1 study | Ungraded |
Restoration of function (return to baseline bite) | Limited data: at the conclusion of the study all participants indicated that they had returned to their "baseline bite". | 1 study | Ungraded |
Intraoperative Rapid IMF vs Eyelet wire ties
Population: Adults with mandibular fractures excluding condyles (following open reduction)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Intraoperative complications | RR 2.6 [1.0, 7.0] | NR | Ungraded |
One microplate plus one miniplate vs Two miniplates
Population: Adults with isolated mandibular fractures in the interforaminal region
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Efficacy and stability of fixation (bite force) | Only one study (Gupta 2012) compared one microplate in conjunction with one miniplate versus two miniplates in isolated interforaminal fractures; however, the data reported in the trial did not satisfy the review's… | 1 study | Ungraded |
Two miniplates (transbuccal approach) vs One miniplate plus two screws (intraoral approach at external oblique ridge)
Population: Adults with fractures of the mandibular angle
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Requirement for additional (surgical) interventions (plate removal) Angle of mandible only | RR 0.78 [0.19, 3.11] | 2 studies | Ungraded |
Post-operative adverse events and complications (lip numbness; overall) Angle of mandible only | Siddiqui 2007: 22/36 (61%) single-miniplate vs 14/26 (54%) two-miniplate had one or more complications; subjective lip numbness 15/36 (41.7%) vs 10/26 (38.5%) (P=0.82), objective 16/36 (44.4%) vs 8/26 (31.7%) (P=0.29).… | 2 studies | Ungraded |
Facial appearance (scarring) Angle of mandible only | Facial scarring, as a result of access through the transbuccal route, occurred in two participants in the two-miniplate group (Siddiqui 2007). | 1 study | Ungraded |
Post-operative infection Angle of mandible only | RR 1.32 [0.41, 4.22] | 2 studies · 93 participants | Ungraded |
Restoration of function (malocclusion) Angle of mandible only | RR 0.46 [0.05, 4.17] | 1 study | Ungraded |
Transbuccal miniplate combined with intraoral approach vs Intraoral approach alone
Population: Adults with fractures of the mandibular angle
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Non-union Angle of mandible only | RR 1.0 [0.17, 5.79] | 1 study · 140 participants | Ungraded |
Facial appearance (scar) Angle of mandible only | The investigators reported that no patients were "recorded as having an unsatisfactory scar", but it was unclear how, when and by whom the assessments were made. | 1 study | Ungraded |
Post-operative infection (persistent) 3 months · Angle of mandible only | RR 0.47 [0.20, 1.09] | 1 study · 138 participants | Ungraded |
Restoration of function (malocclusion; interincisor mouth opening) 3 months · Angle of mandible only | Persistent malocclusion was minimal, reported in one participant in each group at the 3-month follow-up. Mean interincisor mouth opening at 3 months 37.68 mm (range 17 to 50) combined approach vs 38.19 mm (range 22 to… | 1 study | Ungraded |
Requirement for additional (surgical) interventions (plate removal within 90 days) 90 days · Angle of mandible only | RR 0.57 [0.33, 0.98] | 1 study · 140 participants | Ungraded |
Wound dehiscence 3 months · Angle of mandible only | RR 0.43 [0.19, 0.98] | 1 study · 138 participants | Ungraded |
Open (surgical) reduction and fixation vs Closed (non-surgical) treatment
Population: Adults (16 to 68 years) with mandibular fractures excluding condylar involvement
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | "There were no studies comparing different types of closed interventions with one another or comparing open and closed interventions." "We found no studies that compared surgical with non-surgical treatments." | 0 studies | No studies |