Trial reportEuropean journal of orthodontics2023
Effect of an enzyme-containing mouthwash on the dental biofilm and salivary microbiome in patients with fixed orthodontic appliances: a randomized placebo-controlled pilot trial.
Trial report in European journal of orthodontics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05033015 (Effect of an Enzyme-containing Mouth Rinse on Dental Biofilm Accumulation in Patients With Fixed Orthodontic Appliances), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Effect of an Enzyme-containing Mouth Rinse on Dental Biofilm Accumulation in Patients With Fixed Orthodontic Appliances: a Randomized Placebo-controlled Clinical Trial
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Orthodontic treatment and oral microbiota changes: a systematic review of oral dysbiosis revealed by 16S rRNA gene analysis.The Angle orthodontist · 2025Pooled it
- Poor-tasting pediatric medicines: Part 1. A scoping review of their impact on patient acceptability, medication adherence, and treatment outcomes.Frontiers in drug delivery · 2025Pooled it
- The Stain Reduction and Whitening Efficacy of an Enzyme-Enhanced Mouthwash: A Comparative Study.Clinical, cosmetic and investigational dentistry · 2026Article
- The effect of multiple-enzyme treatment onBiofilm · 2025Article
- In Vitro Evaluation of Biofilm Formation by Oral Microorganisms on Clear Aligner Materials: Influence of Mouthwash Exposure.Journal of functional biomaterials · 2025Article
- Expression of mannanase and glucanases in lettuce chloroplasts and functional evaluation of enzyme cocktail against Candida albicans in oral cancer patient samples.Plant biotechnology journal · 2025Article
- Dental biofilms contain DNase I-resistant Z-DNA and G-quadruplexes but alternative DNase overcomes this resistance.NPJ biofilms and microbiomes · 2025Article
- Oral microbiome in human health and diseases.mLife · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMouthwashes containing oral antiseptics or enzymes are suggested suitable for controlling biofilm accumulation in patients with fixed appliances and thereby limiting unwanted side effects during the orthodontic treatment.
objectivesTo evaluate the effect of an enzyme-based mouthwash on the amount of dental biofilm and the composition of the salivary microbiome in patients undergoing treatment with fixed orthodontic appliances. TRIAL
designRandomized double-blind placebo-controlled trial. MATERIAL AND
methodsIn total, 35 young adolescents (14-18 years) under treatment with fixed appliances were consecutively enrolled and randomly allocated to an experimental or a placebo group by opening a computer-generated numbered envelope. The subjects were instructed to rinse twice daily during an intervention period of 8 days with experimental mouthwash or placebo without active enzymes. Unstimulated whole saliva samples were collected at baseline and after 8 days. The participants and examiner were blinded for the allocation. The primary outcome was the Orthodontic Plaque Index (OPI) and the secondary was the composition of the salivary microbiome.
resultsIn total, 28 adolescents (21 females and 7 males) completed the trial and there were no differences in age, clinical, or microbial findings between the test (n = 14) and the placebo group (n = 14) at baseline. We found a decreased OPI in the test group after 8 days and the difference was statistically significant compared with the placebo group (P < 0.05). There were no significant treatment effects on the richness and global composition of the salivary microbiome. HARMS: In total, one participant in the test group claimed nausea and abandoned the project. In total, two participants did not like the taste of the mouthwash but used it as instructed. No other adverse events or side effects were reported. LIMITATIONS: Short-term pilot trials may by nature be sensitive for selection and performance biases and are not designed to unveil persisting effects.
conclusionDaily use of enzyme-containing mouthwash reduced the amount of dental biofilm in adolescents under treatment with the fixed orthodontic appliances, without affecting the composition of the salivary microbiota. ETHICAL APPROVAL: Approved by the Regional Ethical Board, Lund, Sweden (Dnr 2020-05221). CLINICAL
trial registrationNCT05033015.
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