Background Accumulation of dental plaque can lead to gum problems. A fluoride toothpaste containing naturally occurring enzymes and proteins has been shown to improve gingival health and reduce supragingival plaque in European populations. The objective of the current study was to evaluate the ability of this toothpaste to improve gingival condition and reduce supragingival plaque in an alternative study population.
Methods This was a double-blind (participant, examiner, investigator, statistician), randomised, parallel group, efficacy study conducted at a Chinese university dental hospital. Participants (age 18-70) with a mean gingival index (GI) ≥ 1.0 and mean modified Quigley and Hein plaque index (MQHPI) ≥ 1.5 were randomised using sex stratification to twice-daily brushing with either test toothpaste (n=127) or control fluoride toothpaste (n=124) for 26 weeks. Assessments of GI (primary outcome) and MQHPI were conducted at baseline and after 4, 13 and 26 weeks of product use. Results were analysed using ANCOVA model for between product comparison (α= 0.05).
Results One hundred and six participants using test toothpaste and 92 using control toothpaste completed the study. The test toothpaste was more effective than control toothpaste in improving gingival condition after 4, 13 and 26 weeks of product use, with estimate product differences in GI of -0.18 at week 4 (p < 0.0001, 95% CI -0.23 to -0.12), -0.16 at week 13 (p < 0.0001, 95% CI -0.20 to -0.11) and -0.53 at week 26 (p < 0.0001, 95% CI -0.60 to -0.46). The test toothpaste was also significantly more effective than control toothpaste in reducing supragingival plaque after 4, 13 and 26 weeks of product use, with estimated product differences of -0.29 at week 4 (p < 0.0001, 95% CI -0.38 to -0.21), -0.35 at week 13 (p < 0.0001, 95% CI -0.45 to 0.25) and -0.96 at week 26 (p < 0.0001, 95% CI -1.06 to -0.85).
Conclusion The study demonstrated that a toothpaste containing naturally occurring enzymes and proteins significantly improved gingival health and reduced supragingival plaque compared to a control toothpaste, after 4, 13, and 26 weeks of use.
Competing Interest StatementLZ, JRM, SL, JNS, CD are employed by Unilever, which funded this study. AKG was Unilever employee at time of study. XH, PNZ, JT and RH are employees of Xi, an Jiaotong University Dental Hospital, which received funding from the study sponsor for this study.
Clinical TrialNCT06932211
Funding StatementThis clinical study was funded by Unilever.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee of the Hospital of Stomatology, Xi, an Jiaotong University gave ethical approval for this work.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityThe datasets generated and/or analysed during the current study are not publicly available as consent was not received from participants for this purpose.
List of AbbreviationsAEAdverse EventANCOVAAnalysis of CovarianceCIConfidence IntervalCONSORTConsolidated Standards of Reporting TrialsFFluorideGIGingival IndexMQHPIModified Quigley and Hein Plaque IndexPPercentage of sites with no bleedingppmparts per millionSDStandard DeviationUKUnited Kingdom
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