Trial reportBMC oral health2021
Biofilm formation following chitosan-based varnish or chlorhexidine-fluoride varnish application in patients undergoing fixed orthodontic treatment: a double blinded randomised controlled trial.
Trial report in BMC oral health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Changes in the Color and Brightness of White Spots Associated with Orthodontic Treatment 6 Months after the Application of Infiltrative Resins: Systematic Review and Meta-Analysis.International journal of environmental research and public health · 2022Pooled it
- pH-responsive ion release kinetics of a chitosan-based hydrogel incorporating nanohydroxyapatite and sodium fluoride for enamel remineralization.BMC oral health · 2026Article
- Applications of chitosan in oral health and diseases.Frontiers in oral health · 2025Review
- Mouthwashes: Alternatives and Future Directions.International dental journal · 2023Review
- Article
- Xylitol Fluoride Varnish: In Vitro Effect Analysis on Enamel by Atomic Force Microscopy.Biomedicines · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOrthodontic treatment poses an increased risk of plaque accumulation and demineralisation of enamel leading to white spot lesion around the brackets. This parallel arm trial aims to assess the degree of bacterial plaque formation adjacent to orthodontic brackets, following the application of a chitosan-based varnish or chlorhexidene-fluoride varnish.
methodsA total of 200 teeth from 20 patients undergoing fixed orthodontic therapy were assessed and biofilm formation around the brackets were recorded using the Bonded Bracket Index (Plaque index) at baseline and weekly for 6 weeks. The bacterial count and plaque pH at corresponding weekly intervals were also recorded. Following bracket bonding, the patients were cluster randomised to receive chitosan-based varnish-CHS (UNO Gel Bioschell, Germiphene corp., Brantford, Canada) or chlorhexidine-fluoride varnish-CFV (Cervitec F, Ivoclar Vivadent, Schaan, Liechtenstein) every week on the representative teeth respectively. BBI proportions were compared between groups at all time intervals using Chi square test. Mean plaque bacterial count and plaque pH were compared using Mann Whitney U test and Tukey's HSD test respectively.
resultsBaseline characteristics were similar between the groups: Mean age was CHS = 23 and CFV = 21; male to female ratio was CHS = 5/5, CFV = 7/3. At the end of 6 weeks, chitosan-based varnish performed equal to chlorhexidine-fluoride varnish (P > 0.05) with 98% and 95% of teeth with acceptable scores respectively. The plaque bacterial count significantly reduced at 6 weeks for both varnish compared to the baseline; The value for CHS was 0.43 ± 0.4 × 10
conclusionThis trial showed that both chitosan-based varnish and chlorhexidine-fluoride varnish reduced bacterial count, while the plaque pH remained neutral over a period of six weeks in patients undergoing fixed orthodontic therapy. The anti-plaque effects of the natural biopolymeric chitosan-based varnish was similar to that of chlorhexidine-fluoride varnish, a known chemotherapeutic agent. Registration: This trial protocol was registered with https://www.ctri.nic.in (CTRI/2019/05/018896). (Date of registration 02/05/2019). PROTOCOL: The protocol was not published before trial commencement.
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Registered trials
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.