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Background <p>Accumulation of dental plaque can lead to gingival 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.</p> Methods <p>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 at baseline 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).</p> Results <p>One hundred and six participants using test toothpaste and 92 using control toothpaste completed the study. The test toothpaste showed significantly greater improvements in gingival health than the control toothpaste. The estimated differences in GI between groups were –0.18 (95% CI: –0.23 to –0.12) at week 4, –0.16 (95% CI: –0.20 to –0.11) at week 13, and –0.53 (95% CI: –0.60 to –0.46) at week 26 (all <i>p</i> &lt; 0.0001). Similarly, reductions in supragingival plaque were greater in the test group, with differences in MQHPI of –0.29 (95% CI: –0.38 to –0.21) at week 4, –0.35 (95% CI: –0.45 to –0.25) at week 13, and –0.96 (95% CI: –1.06 to –0.85) at week 26 (all <i>p</i> &lt; 0.0001).</p> Conclusions <p>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.</p> Clinical trial registration <p>NCT06932211 (retrospectively registered on April 17, 2025).</p>

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The effect of enzyme and protein containing toothpaste on gingival condition: a randomised controlled study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月3日

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  • Xiao Hu,
  • PingNeng Zhang ,
  • Lu Zhang,
  • Jane R Matheson,
  • Shengnan Lin,
  • Jianing N. Sun,
  • Cristina Delfanti,
  • Jiangang Tian,
  • Ashok K Gupta,
  • Renuka Vasantharaghavan,
  • Ruizhe Huang

摘要

Background

Accumulation of dental plaque can lead to gingival 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 at baseline 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 showed significantly greater improvements in gingival health than the control toothpaste. The estimated differences in GI between groups were –0.18 (95% CI: –0.23 to –0.12) at week 4, –0.16 (95% CI: –0.20 to –0.11) at week 13, and –0.53 (95% CI: –0.60 to –0.46) at week 26 (all p < 0.0001). Similarly, reductions in supragingival plaque were greater in the test group, with differences in MQHPI of –0.29 (95% CI: –0.38 to –0.21) at week 4, –0.35 (95% CI: –0.45 to –0.25) at week 13, and –0.96 (95% CI: –1.06 to –0.85) at week 26 (all p < 0.0001).

Conclusions

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.

Clinical trial registration

NCT06932211 (retrospectively registered on April 17, 2025).