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Evaluation of a mouthrinse containing guava leaf extract as part of comprehensive oral care regimen- a randomized placebo-controlled clinical trial.

  • 2019-11-21
  • BMC complementary and alternative medicine 19(1)
    • Namratha Nayak
    • Jothi Varghese
    • Seema Shetty
    • Vinutha Bhat
    • Tejal Durgekar
    • Richard Lobo
    • Usha Y Nayak
    • Vishwanath U

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 20
Population
Sixty subjects (n = 20) in compliance with the inclusion criteria
Methods
randomly assigned to one of the 3 study groups i.e. Group A- 0.15%Guava mouth rinse, Group B- 0.2% Chlorhexidine (CHX) mouth rinse, Group C- Distilled water (placebo); all received professional oral prophylaxis and used mouth rinse for 30 days
Blinding
Open-label
Duration
30 days
Funding
Unclear

Background

The control of biofilm adherence on tooth surface has always been the keystone of periodontal therapeutic systems. However, prevalence of gingivitis suggest inadequacy of self-performed oral hygiene measures and need for adjunctive aid for mechanical plaque control. Oral rinses containing chlorhexidine, has been widely used however, with certain limitations. Herbal products have been used widely reflecting its action as alternative and complementary remedy. Hence, the purpose of the present study was to evaluate the antimicrobial and antioxidant efficacy of a Guava leaf extract based mouthrinse in patients with chronic generalized gingivitis as an adjunct to oral prophylaxis.

Methods

Sixty subjects (n = 20) in compliance with the inclusion criteria were randomly assigned to one of the 3 study groups i.e. Group A- 0.15%Guava mouth rinse, Group B- 0.2% Chlorhexidine (CHX) mouth rinse, Group C- Distilled water (placebo). All the participants received professional oral prophylaxis and were dispensed with experimental mouth rinses and instructed to use for period of 30 days. Clinical parameters such as gingival index, plaque index along with microbial colony forming units using plaque samples and antioxidant levels in saliva were estimated at baseline, 30 and 90 days' time intervals.

Results

All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group. Although there was improvement in the antioxidant status in all study participants, yet there was no statistically significant difference observed.

Conclusion

Guava mouth rinse can be used as an empirical adjunct to professional oral prophylaxis owing to its multifactorial properties and favourable acceptance. However, long term studies need to be conducted to validate its use for an extended period of time.

Trial registration

The clinical trial has been prospectively registered on 17th February 2017 by the Clinical Trials Registry-India (CTRI/2017/02/007898).

Research Insights

  • guava→Improved Total Antioxidant Status

    Although there was improvement in the antioxidant status in all study participants, yet there was no statistically significant difference observed.

    Effect
    Neutral
    Effect size
    Small
    Dose
    0.15% mouth rinse
  • guava→Reduced Gingival Index

    All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    0.15% mouth rinse
  • guava→Reduced Microbial Colony Forming Unit

    All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    0.15% mouth rinse
  • guava→Reduced Plaque Index

    All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    0.15% mouth rinse
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