Cochrane · intervention · CD008455
Interventions for treating bisphosphonate‐related osteonecrosis of the jaw (BRONJ)
Rollason, V, Laverrière, A, MacDonald, LCI, et al. · Cochrane Database of Systematic Reviews · 2016 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
22
current version
GRADE rated
2
No studies
10
Included studies
1
as reported
No studies 10 · 45.5%Ungraded 10 · 45.5%Very low 2 · 9.1%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 | People of any age and either sex, in any setting, with BRONJ; bisphosphonate exposure past or current; people with cancer (receiving chemotherapy, corticosteroids or hormonal therapies) and people with osteoporosis; diagnosis of BRONJ could be clinical but preferably confirmed with radiological and histological data | 49 participants randomised (45 contributed data for the first analysis at three months and 18 at 18 months' follow-up); mean age 66.3 years (control) and 66.1 years (hyperbaric oxygen therapy group); treated with bisphosphonates for multiple myeloma (39.6%), breast cancer (25%), osteoporosis (14.6%) or another indication (20.4%) |
| Intervention | Surgical or non-surgical management of BRONJ. Non-surgical: use of topical or systemic interventions. Surgical: debridement, necrotic bone resection, sequestrum removal or dental extraction within osteonecrotic bone, more extensive resection of affected bone and reconstructive surgery (including allografts or xenografts) | Hyperbaric oxygen therapy plus standard care (n=22) |
| Comparison | Any experimental intervention (surgical or non-surgical) versus none (placebo; no treatment); any experimental intervention versus an active control (surgical or non-surgical); any combined intervention versus none (placebo; no treatment); any combined intervention versus an active control (surgical, non-surgical or a combined intervention) | Standard care alone: surgery, antibiotics and oral rinses at discretion of oral-maxillofacial surgeon (n=27) |
| Outcomes | Primary: Healing of the osteonecrosis (improvement in clinical grade, wound healing, improvement in exposed bone quality, halt in bone disease progression, healing of sinus tract or deep periodontal pockets). Secondary: Mortality rate and cause of death; pain; improvement of pre-existing accompanying symptoms other than pain; improvement in nutritional intake; quality of life; health economic measures. Adverse events: any effect reported as an adverse effect; new or worsening signs of infection, intraoperative bleeding, medication adverse effects | Healing of the osteonecrosis (n=45); Pain (n=42); Quality of life (n=49) |
| Study designs | RCTs (published or unpublished); split-mouth studies of treatments that could contaminate other sites in the mouth were excluded | RCT (n=1) |
| Timing | Any length of treatment; all administration routes for drug therapy; time points classified as immediate (<24 h), early (1-8 days) and long-term (>8 days) | Healing measured at baseline, 3, 6, 12 and 18 months and last contact; pain measured weekly; quality of life measured at baseline and 6 months |
Search date: 2015-12. Databases: Cochrane Oral Health Group Trials Register; Cochrane Breast Cancer Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; EMBASE via Ovid; CancerLit via PubMed; CINAHL via EBSCO; AMED via Ovid; Database of Randomised Controlled Trials in Hyperbaric…
Questions and results
Show all 2 versionsAny experimental intervention (surgical or non-surgical) vs None (placebo or no treatment)
Population: People of any age and either sex, in any setting, with BRONJ; bisphosphonate exposure past or current; includes people with cancer and with osteoporosis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Quality of life | no estimate extracted | 0 studies | No studies |
Improvement of pre-existing accompanying symptoms other than pain | no estimate extracted | 0 studies | No studies |
Health economic measures | no estimate extracted | 0 studies | No studies |
Improvement in nutritional intake | no estimate extracted | 0 studies | No studies |
Adverse events | no estimate extracted | 0 studies | No studies |
Pain | no estimate extracted | 0 studies | No studies |
Mortality rate and cause of death | no estimate extracted | 0 studies | No studies |
Healing of the osteonecrosis | no estimate extracted | 0 studies | No studies |
Any experimental intervention (surgical or non-surgical) vs Active control (surgical or non-surgical)
Population: People of any age and either sex, in any setting, with BRONJ; bisphosphonate exposure past or current; includes people with cancer and with osteoporosis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Healing of the osteonecrosis | no estimate extracted | 0 studies | No studies |
Hyperbaric oxygen therapy plus standard care (surgery, antibiotics, oral rinse) vs Standard care alone (surgery, antibiotics, oral rinse)
Population: People with BRONJ (mean age ~66 years; most treated with bisphosphonates for cancer (multiple myeloma, breast cancer) or osteoporosis)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Healing of osteonecrosis - improvement ('healed' or 'improved' vs 'unchanged' or 'worse') 18 months | RR 1.75 [0.51, 5.98] | 1 study · 18 participants | Ungraded |
Healing of osteonecrosis - improvement ('healed' or 'improved' vs 'unchanged' or 'worse') Last contact | RR 1.78 [0.97, 3.28] | 1 study · 46 participants | Ungraded |
Healing of osteonecrosis - improvement ('healed' or 'improved' vs 'unchanged' or 'worse') 3 months | RR 1.94 [1.01, 3.74] 350 vs 680 | 1 study · 45 participants | Very low Downgraded: risk of bias, imprecision |
Healing of osteonecrosis - healed ('healed' vs 'improved', 'unchanged' or 'worse') 12 months | RR 1.20 [0.39, 3.65] | 1 study · 24 participants | Ungraded |
Adverse effects | no estimate extracted | 0 studies | No studies |
Healing of osteonecrosis - healed ('healed' vs 'improved', 'unchanged' or 'worse') Last contact | RR 1.56 [0.77, 3.18] | 1 study · 46 participants | Ungraded |
Healing of osteonecrosis - healed ('healed' vs 'improved', 'unchanged' or 'worse') 18 months | RR 1.00 [0.25, 4.00] | 1 study · 18 participants | Ungraded |
Healing of osteonecrosis - healed ('healed' vs 'improved', 'unchanged' or 'worse') 6 months | RR 0.95 [0.44, 2.04] | 1 study · 40 participants | Ungraded |
Healing of osteonecrosis - healed ('healed' vs 'improved', 'unchanged' or 'worse') 3 months | RR 3.60 [0.87, 14.82] 100 vs 360 | 1 study · 45 participants | Very low Downgraded: risk of bias, imprecision |
Pain Weekly (to 16 weeks) | no estimate extracted | 1 study · 42 participants | Ungraded |
Healing of osteonecrosis - improvement ('healed' or 'improved' vs 'unchanged' or 'worse') 6 months | RR 1.31 [0.78, 2.22] | 1 study · 40 participants | Ungraded |
Healing of osteonecrosis - improvement ('healed' or 'improved' vs 'unchanged' or 'worse') 12 months | RR 1.65 [0.75, 3.64] | 1 study · 24 participants | Ungraded |
Quality of life Baseline and 6 months | no estimate extracted | 1 study · 49 participants | Ungraded |