Cochrane · intervention · CD011559
Interventions for preventing osteoradionecrosis of the jaws in adults receiving head and neck radiotherapy
El‐Rabbany, M, Duchnay, M, Raziee, HR, et al. · Cochrane Database of Systematic Reviews · 2019 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
8
current version
GRADE rated
8
No studies
0
Included studies
4
as reported
No studies 0 · 0%Ungraded 0 · 0%Very low 8 · 100%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 | All adult head and neck cancer patients who underwent radiotherapy, either curative or adjuvant, having received radiation to the mandible or maxilla or both. Excluded: patients treated with palliative intent; re-irradiated patients; child and adolescent populations. | 342 adults with head and neck cancer treated with radiotherapy across 4 trials (Horiot 1983 randomised 220, 190 evaluated; Marx 1985 74; Schoen 2007 26; Batstone 2012 22) |
| Intervention | Any form of prophylactic intervention (local, systemic, or behavioural, or combinations). Excluded: interventions directly related to cancer therapy (modified radiotherapy or chemotherapy regimens). Examples: prophylactic/symptomatic extraction with intra-operative surgical technique; endodontic/periodontal therapy; caries prevention measures; stents/radiation guards; topical antibiotics; ultrasound; hyperbaric oxygen therapy; systemic prophylactic antibiotics; NSAIDs; corticosteroids; pentoxifylline; tocopherol; platelet-rich plasma; patient education. | PRP in cellulose foam placed in extraction socket (n=22); Fluoride gel 450 ppm (n=99); Hyperbaric oxygen therapy following extractions (n=37); Combined hyperbaric oxygen therapy and perioperative antibiotics prior to implant therapy (n=13) |
| Comparison | No limitations on control interventions were defined. | Cellulose foam only/placebo (n=22); High-content fluoride toothpaste 1350 ppm (n=91); Perioperative antibiotic prophylaxis penicillin G (n=37); Antibiotics alone (n=13) |
| Outcomes | Primary: Incidence of ORN (an area of devitalized and exposed bone that fails to heal over three to six months in the absence of local neoplastic disease). Secondary: Adverse effects of interventions (hospitalization, morbidity e.g. pain, loss of sensation, effects on taste, and mortality). | Incidence of ORN (n=4); Adverse effects (n=4) |
| Study designs | Randomised controlled trials (RCTs) or quasi-RCTs of any intervention for the prevention of ORN, as long as incidence of ORN was reported as a primary or secondary outcome. Excluded: cluster trials; cross-over trials. | Randomised controlled trials, including one split-mouth trial (n=4) |
| Timing | Not restricted with regard to time points but those with more sufficient follow-up (preferably greater than three years) given greater weight. | Follow-up: 5 years (Batstone 2012); 14 to 36 months (Horiot 1983); 6 months (Marx 1985); 1 year (Schoen 2007) |
Search date: 2019-11. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; AMED (Allied and Complementary Medicine) Ovid; Scopus; Proquest Dissertations and Theses International; Web of Science Conference Proceedings; US National Institutes of…
Questions and results
Current version onlyPRP (platelet-rich plasma) in cellulose foam placed in extraction socket vs No treatment/placebo (cellulose foam only) placed in extraction socket
Population: Adults with head and neck cancer undergoing curative or adjuvant radiotherapy (at risk of osteoradionecrosis of the jaws)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Incidence of ORN 5-year follow-up | OR 3.32 [0.58, 19.09] | 1 study · 44 participants | Very low Downgraded: risk of bias, imprecision |
Adverse effects (wound pain) 2 weeks to 12 months | This comparison was only made in 1 study: mean pain scores at 2 weeks, 2, 6, 9, and 12 months showed no 'significant' differences between the 2 groups (self-reported Likert scale 1 to 10; difference at 2 weeks P =… | 1 study · 44 participants | Very low Downgraded: risk of bias, imprecision |
Fluoride gel (450 ppm) vs High-content fluoride toothpaste (1350 ppm)
Population: Adults with head and neck cancer undergoing curative or adjuvant radiotherapy (at risk of osteoradionecrosis of the jaws)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects 14 to 36 months | Adverse effects were an outcome of interest in the study conducting this comparison, however no mention was made of the presence or absence of any adverse events | 1 study · 220 participants | Very low Downgraded: risk of bias, imprecision |
Incidence of ORN 14 to 36 months | This comparison was only made in 1 study, which showed no difference between the 2 interventions: no patients in either group developed ORN (12- to 36-month follow-up) (0/99 in the fluoride gel group and 0/91 in the… | 1 study · 220 participants | Very low Downgraded: risk of bias, imprecision |
Hyperbaric oxygen therapy (HBO) following extractions vs Perioperative antibiotic prophylaxis (penicillin G) following extractions
Population: Adults with head and neck cancer undergoing curative or adjuvant radiotherapy (at risk of osteoradionecrosis of the jaws)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects 6 months | Adverse effects were an outcome of interest in the study conducting this comparison, however no mention was made of the presence or absence of any adverse events | 1 study · 74 participants | Very low Downgraded: risk of bias, imprecision |
Incidence of ORN 6 months | RR 0.18 [0.43, 0.76] | 1 study · 74 participants | Very low Downgraded: risk of bias, imprecision |
Combined HBO and perioperative antibiotics prior to dental implant therapy vs Antibiotics alone prior to dental implant therapy
Population: Adults with head and neck cancer undergoing curative or adjuvant radiotherapy (at risk of osteoradionecrosis of the jaws)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects (including quality of life) 1 year | This comparison was only made in 1 study which reported no serious adverse events associated with HBO therapy. Quality of life measures (oral status, functioning, satisfaction) showed emotional functioning and pain… | 1 study · 26 participants | Very low Downgraded: risk of bias, imprecision |
Incidence of ORN 1 year | RR 3.00 [0.14, 65.16] | 1 study · 26 participants | Very low Downgraded: risk of bias, imprecision |
Any non-treatment-dependent prophylactic intervention (local, systemic, or behavioural, or combinations) for preventing ORN vs Placebo, standard care, no intervention, or an alternate/active prophylactic intervention
Population: Adults with head and neck cancer undergoing curative or adjuvant radiotherapy (at risk of osteoradionecrosis of the jaws)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | no estimate extracted | 0 studies | No studies |