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Record W4410214727 · doi:10.1186/s12874-025-02547-9

Spin Bias in randomized controlled trials of botulinum toxin for bruxism management: a meta-epidemiologic study

2025· article· en· W4410214727 on OpenAlexaff
Graziela De Luca Canto, Patrícia Pauletto, Cristine Miron Stefani, Thaís Marques Simek Vega Gonçalves, Nelson Carvas, Carlos Flores‐Mir, Ana Carolina Pereira Nunes Pinto, Virgínia Fernandes Moça Trevisani

Bibliographic record

VenueBMC Medical Research Methodology · 2025
Typearticle
Languageen
FieldHealth Professions
TopicTemporomandibular Joint Disorders
Canadian institutionsUniversity of Alberta
FundersConselho Nacional de Desenvolvimento Científico e Tecnológico
KeywordsRandomized controlled trialMeta-analysisBotulinum toxinMedicineMEDLINEPhysical therapyInternal medicineSurgeryBiology

Abstract

fetched live from OpenAlex

OBJECTIVE: To perform a quantitative and qualitative analysis of spin bias in randomized clinical trials (RCTs) focusing on botulinum toxin (BTX-A) for managing bruxism. STUDY DESIGN AND PROTOCOL: This is a meta-epidemiologic study. The protocol was registered on the Open Science Framework. STUDY SELECTION: We included RCTs that evaluated the effectiveness of BTX-A for managing bruxism, associated or not with signs and symptoms of temporomandibular disorders. The outcomes were changes in pain and bruxism events. Spin bias was investigated in abstract and main text. The frequency of spin bias was assessed, and a qualitative analysis was conducted. The study was classified as effective if the outcome analyzed was statistically significant (p-value 0.05) and reached the minimum important difference of 20% and ineffective if the reported outcome was statistically nonsignificant or the study did not report the p-value or the results did not reach the minimum important difference of 20%. RESULTS: An overall frequency of 59.4% spin bias was identified in eight included RCTs. The conclusion in the main text (87.5%) was the section with the highest frequency of spin bias. In the qualitative analysis, the most common strategies identified were inadequate extrapolation to a large population (30.61%), inadequate implication for clinical practice (20.41%), and misleading reporting (12.25%). CONCLUSION: There is a high frequency of spin bias in RCTs that evaluated BTX-A for bruxism management. Close to 90% of the selected RCTs presented spin bias in the main text's conclusion. The most common spin was the inadequate extrapolation of the results. CLINICAL SIGNIFICANCE: Applying BTX into the temporalis did not reduce muscle activity and the results for masseter injections remain controversial. It seems that BTX-A injections can reduce pain from two weeks to one year. It is not possible to have certainty about the efficacy and safety of using BTX-A to reduce pain and bruxism events.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.782
metaresearch head score (Gemma)0.922
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (broad), Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.222
Threshold uncertainty score0.998

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.7820.922
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0180.002
Bibliometrics0.0020.001
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.001
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0030.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.880
GPT teacher head0.719
Teacher spread0.160 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; both teacher heads agree on what is shown here.

Study designRandomized trial
DomainMethods
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2025
Admission routes1
Has abstractyes

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