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
Current version only2 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 |
Open reduction and fixation (any technique) vs Closed reduction and fixation (any technique)
Population: People over 55 years of age with fractures of the atrophic (less than 20 mm vertical height) edentulous mandible (symphysis, parasymphysis, body, angle, ramus, condyle, coronoid process), resulting from trauma, implant insertion or pathological fracture
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible randomised controlled trials were identified. "A large number of studies were retrieved in our comprehensive search of the literature none of which were eligible ... and therefore no data were available for… | 0 studies | No studies |
Open reduction and fixation (any technique) vs Closed reduction and fixation (any technique)
Population: People over 55 years of age with fractures of the atrophic (less than 20 mm vertical height) edentulous mandible (symphysis, parasymphysis, body, angle, ramus, condyle, coronoid process), resulting from trauma, implant insertion or pathological fracture
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol only. The review set out to compare open versus closed management of the fractured edentulous atrophic mandible; no literature search or study inclusion had yet been undertaken. | NR | No studies |