Evidence map›Paper›PMID 33997959›Full record

Trial reportDevelopmental medicine and child neurology2021

Surgery versus botulinum neurotoxin A to reduce drooling and improve daily life for children with neurodevelopmental disabilities: a randomized controlled trial.

Stijn Bekkers, Ineke M J Pruijn, Jan J W van der Burg, Karen van Hulst, Saskia E Kok, Corinne P Delsing, Arthur R T Scheffer, Frank J A van den Hoogen

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Developmental medicine and child neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Management of Paediatric Sialorrhea: Outcomes of Botulinum Toxin and Surgical Procedures in a UK Tertiary Centre.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2026
    Article
  4. Review
  5. Review
  6. Staggered botulinum toxin-a injections into parotid and submandibular glands prior to four-duct ligation for pediatric sialorrhea.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Stijn BekkersDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.ORCID 0000-0002-8330-9243
Ineke M J PruijnDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.ORCID 0000-0002-9439-5626
Jan J W van der BurgDepartment of Pediatric Rehabilitation, Sint Maartenskliniek, Nijmegen, the Netherlands.
Karen van HulstDepartment of Rehabilitation, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, the Netherlands.ORCID 0000-0001-9456-3450
Saskia E KokDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.ORCID 0000-0003-4773-5461
Corinne P DelsingDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.ORCID 0000-0001-7587-9791
Arthur R T SchefferDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Frank J A van den HoogenDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the effect of bilateral submandibular duct ligation and botulinum neurotoxin A (BoNT-A) on drooling severity and its impact on daily life and care in children and adolescents with moderate-to-severe drooling.

methodThis was a randomized, interventional, controlled trial in which 53 children and adolescents (31 males, 22 females, mean age 11y, range 8-22y, SD 2y 10mo) with cerebral palsy (58.5%) or other non-progressive developmental disorders (41.5%) were randomized to BoNT-A (n=26) or bilateral submandibular duct ligation (n=27). A parent questionnaire on the severity of drooling in specific positions and daily activities and the impact of drooling on daily life and care was filled out at baseline and 8 and 32 weeks posttreatment.

resultsBoth BoNT-A and bilateral submandibular duct ligation had a positive effect on daily care, damage to electronic equipment and/or furniture, social interactions, and self-esteem. However, bilateral submandibular duct ligation had a significant greater and longer-lasting short- (8wks) and medium-term (32wks) effect on daily care, reducing damage to electronic devices, and improving social interactions and satisfaction with life in general.

interpretationThis randomized controlled trial confirms reduced drooling by both BoNT-A and bilateral submandibular duct ligation, but provides new evidence on improved well-being through a reduction in drooling. Even though there is a greater risk of complications and morbidity after bilateral submandibular duct ligation, compared to BoNT-A there was a significantly greater and longer-lasting positive effect on most outcomes. What this paper adds Bilateral botulinum neurotoxin A (BoNT-A) and submandibular duct ligation had a positive effect on the well-being of individuals with moderate-to-severe drooling. Bilateral submandibular duct ligation had a greater effect on the impact of drooling during daily care than BoNT-A. Bilateral submandibular duct ligation reduced damage to electronic devices and improved social interactions and satisfaction with life.

Indexed as

Quality of LifeAdolescentBotulinum Toxins, Type AChildDevelopmental DisabilitiesFemaleHumansMaleSalivary DuctsSialorrheaTreatment OutcomeYoung AdultBotulinum Toxins, Type A

Identifiers

PMID33997959
PMCPMC8597158

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.