Non-Cochrane · intervention · PM33340083
Oral health effects of botulinum toxin treatment for drooling: a systematic review.
Corrêa L-B, Basso M-B, Sousa-Pinto B, et al. · Medicina oral, patologia oral y cirugia bucal · 2021 · PubMed · doi:10.4317/medoral.24101
Full textEvery question was extracted from the full text, figures and supplements by two independent LLM extractors, disagreements adjudicated. Rows cite where in the review the value comes from.
Questions
8
current version
GRADE rated
0
No studies
1
Included studies
8
linked below
No studies 1 · 12.5%Ungraded 7 · 87.5%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 | Patients with drooling treated with intraglandular BoNT injections into salivary glands, irrespective of underlying disease | 5 studies of patients with neurological disease-related drooling (cerebral palsy, Parkinson disease, adults with sialorrhea) |
| Intervention | Intraglandular botulinum neurotoxin (BoNT) injection into salivary glands | Intraglandular BoNT-A or BoNT-B injection (n=5) |
| Comparison | No BoNT / placebo / pre-treatment baseline (comparisons within experimental and observational studies) | Placebo (2 RCTs) or pre-treatment baseline (3 quasi-experimental studies) |
| Outcomes | (i) dental caries development; (ii) salivary composition (oral pH, buffering capacity, osmolality); (iii) cariogenic bacterial counts (S. mutans and Lactobacilli) | Caries (n=2 studies), oral pH (n=3), buffering capacity (n=2), S. mutans counts (n=3), Lactobacilli counts (n=3); osmolality (n=0) |
| Study designs | Experimental (RCTs) and observational studies; no language, publication-status or date restrictions | 2 randomized controlled trials and 3 quasi-experimental studies (n=5) |
| Timing | Not specified | Follow-up varied; several outcomes assessed about 1 month after injection |
Search date: 2019-05. Databases: PubMed; CENTRAL; Web of Science; Scopus; manual search of books and conference abstracts; reference lists of included studies
Questions and results
Intraglandular botulinum neurotoxin (BoNT) injection vs No BoNT (placebo or pre-treatment baseline)
Population: Patients with drooling (sialorrhea) due to neurological disease
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Salivary osmolality (hydration level) No included study reported salivary osmolality; this pre-planned outcome remains unassessed (no studies). Source: Material and Methods (planned outcomes); Discussion (limited evidence for salivary osmolarity) · same question in other reviews | no estimate extracted | 0 studies | No studies |
New dental caries development BoNT-B 2500 U vs placebo (Isaacson RCT) In one RCT, BoNT-B 2500 U was not associated with a statistically significant increase in new caries versus placebo (RR 2.4, 95% CI 0.48 to 11.80; not significant). Source: Results (Carious lesions); RR calculated by the review authors · same question in other reviews | RR 2.4 [0.48, 11.80] | 1 study | Ungraded |
Salivary Lactobacilli counts Before vs after BoNT injection (2018 study: significant Lactobacilli increase at 1 month; Wu 2011 and 2017 study no change) Salivary Lactobacilli counts were unchanged in two studies but significantly increased in one study one month after BoNT (ungraded; no effect estimate reported). Source: Results (S. mutans and Lactobacilli salivary counts) · same question in other reviews | No statistically significant changes in Lactobacilli CFU counts were reported by Wu et al. or by Tiigimae-Saar 2017. However, the 2018 study found that Lactobacilli CFU counts were significantly increased one month… | 3 studies | Ungraded |
New dental caries development BoNT-B 3500 U vs placebo (Isaacson RCT) In one RCT, BoNT-B 3500 U was not associated with a statistically significant increase in new caries versus placebo (RR 1.4, 95% CI 0.24 to 8.12; not significant). Source: Results (Carious lesions); RR calculated by the review authors · same question in other reviews | RR 1.4 [0.24, 8.12] | 1 study | Ungraded |
Oral/salivary pH Before vs after BoNT injection BoNT injections were not associated with significant changes in oral/salivary pH across three studies (ungraded; no effect estimate reported). Source: Results (Oral pH) · same question in other reviews | Wu et al. did not observe significant differences in participants' oral pH before and after BoNT-A injections between the active and control groups. There were also no statistically significant differences regarding… | 3 studies | Ungraded |
Salivary Streptococcus mutans counts Before vs after BoNT injection BoNT injections were not associated with significant changes in salivary S. mutans counts across three studies (ungraded; no effect estimate reported). Source: Results (S. mutans and Lactobacilli salivary counts) · same question in other reviews | The RCT by Wu et al. reported no statistically significant changes in S. mutans CFU counts (p-values only). The studies of Tiigimae-Saar did not find statistically significant differences in S. mutans CFU counts either. | 3 studies | Ungraded |
Salivary buffering capacity Before vs after BoNT injection (2018 study: significant buffering increase at 1 month; 2017 study no change) Salivary buffering capacity did not decrease after BoNT; one of two quasi-experimental studies reported a significant increase (ungraded; no effect estimate reported). Source: Results (Salivary buffering capacity) · same question in other reviews | The quasi-experimental studies of Tiigimae-Saar found different results concerning the changes in buffering capacity. For the analysis carried out in 2017, no statistically significant change was observed. By contrast,… | 2 studies | Ungraded |
Comparison
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
New dental caries development Onabotulinumtoxin A open-label, no control (Møller 2015) | Event count (narrative; no estimate) No cases of tooth decay (0 caries events) | 1 study | Ungraded |
AMSTAR 2 appraisal
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | No | no |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | No | Yes | no |
| 4Comprehensive literature searchcritical | Yes | Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Yes | Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: Yes | NRSI: Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: N/A · NRSI: N/A | NRSI: N/A · RCT: N/A | no |
| 12Impact of risk of bias on the pooled results | N/A | N/A | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | N/A | N/A | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Low | Low | yes |
Included primary studies 8
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| Tiigimae-Saar 2018 Saliva changes in Parkinson’s disease patients after injection of Botulinum neurotoxin type A DOI:10.1007/s10072-018-3279-4 | 1 other review | not stated | not extracted yet | not extracted yet |
| Isaacson 2020 Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial. PMID:31930364 | this review only | New dental caries development | not extracted yet | not extracted yet |
| Moller 2015 Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study. PMID:26134257 | this review only | New dental caries development | not extracted yet | not extracted yet |
| Tiigimae-Saar 2017 Does Botulinum neurotoxin type A treatment for sialorrhea change oral health? DOI:10.1007/s00784-016-1826-z | this review only | not stated | not extracted yet | not extracted yet |
| Tiigimäe-Saar 2017 Does Botulinum neurotoxin type A treatment for sialorrhea change oral health? PMID:27114092 | this review only | not stated | not extracted yet | not extracted yet |
| Tiigimäe-Saar 2018 Saliva changes in Parkinson's disease patients after injection of Botulinum neurotoxin type A. PMID:29460161 | this review only | not stated | not extracted yet | not extracted yet |
| Wu 2011 Botulinum Toxin Type A on Oral Health in Treating Sialorrhea in Children With Cerebral Palsy: A Randomized, Double-Blind,… DOI:10.1177/0883073810395391 | this review only | not stated | not extracted yet | not extracted yet |
| Wu 2011 Botulinum toxin type A on oral health in treating sialorrhea in children with cerebral palsy: a randomized, double-blind,… PMID:21551374 | this review only | not stated | not extracted yet | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).
| Review | Shared studies | Jaccard |
|---|---|---|
| The effectiveness and safety of botulinum toxin injections for the treatment of sialorrhea with Parkinson's disease: a systematic review… (2023) | 1 | 0.07 |