Antiplaque Efficacy of Two Novel Commercially Available Herbal Toothpastes.
Condition: Gingivitis; Plaque, Dental
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      Maintaining proper oral hygiene is essential in the prevention of oral as well as general
      illness. The use of herbal medicine in dentistry is growing exponentially over the years.
      Today, herbal medicine is considered an effective alternative to manufactured medication.

      The objective of this current randomized control study is to assess the anti-plaque
      efficiency of Miswak (Salvadora Persica) and Eucalyptus toothpaste in the treatment of
      gingivitis.

      Materials and Methods: This randomized experimental study enrolled 30 healthy individuals as
      controls and 30 individuals with mild to moderate gingivitis. The study lasted 20 days and
      included a two-week washout period between Miswak and Eucalyptus toothpaste. The gingival and
      plaque index were measured at specific time intervals during the research period.
    

Detailed description: 
      The Ajman University Ethical Committee accepted the current randomized trial; the reference
      number is (D-H-S-2021-NOV-24-19). The research was conducted from January 1, 2022, to March
      1, 2022. The current study was carried out following CONSORT standards and the Helsinki
      Declaration as updated in 2013. The following kinds of toothpaste were used in this
      randomized crossover clinical study: Miswak toothpaste (Dabur, India) contains contains
      primarily miswak, with traces of other elements; Eucalyptus toothpaste (Eucalyptus-Bio
      (Argiletz, France)) contains primarily eucalyptus, with traces of other elements Patient
      Selection The PS program online version 3.16 (power and sample size calculations) was used to
      calculate the sample size. The inclusion criteria included subjects who are medically fit,
      subjects with gingival inflammation not progressed into periodontitis, and subjects between
      the age of 20-and 60 years. The exclusion criteria included subjects who are medically
      compromised, subjects on active treatment of antibiotics and corticosteroids, subjects with
      periodontitis (according to the AAP 2017 classification), subjects who have undergone a
      periodontal therapy for the past 3 months, and subjects who are healthy but have been using
      herbal dentifrices. A total of 120 subjects were examined However, only Thirty gingivitis
      patients and thirty healthy patients to be used as a control met the inclusion criteria.

      Study Design This crossover randomized single-blinded study was conducted with a 20-day total
      examination period. The individuals were informed in great detail about the necessity for
      clinical evaluation for research objectives, and a signed agreement was acquired. A sample
      size of 30 patients with gingivitis was selected and the other 30 patients without gingivitis
      were used as a control. Randomization to which study group participants will belong was done
      by drawing lots into either the test 1 (Dabur Miswak, India), test 2(Eucalyptus-Bio,
      Argiletz, France), or the Active control group. To achieve blinding, serial opaque cardboard
      boxes with pre-assigned numbers corresponding to the Lot randomization code will be utilized
      to assign participants to their appropriate groups. After being assigned to their respective
      groups, the participants were blinded. On the first (baseline) day of the trial, all
      individuals were subjected to an oral examination. The baseline score was obtained for
      patients who met the inclusion criteria at the beginning of the study and followed up
      throughout the study.

      The participants were given a dentifrice that had been labeled and tagged with a number. All
      participants were asked to brush their teeth twice daily with a 1cm line of paste in their
      respective brushes for two minutes, once in the morning and the other at night, using the
      modified bass technique. The technique will be demonstrated to the patient and an image of
      the technique provided to the participants. The Oral hygiene index(Plaque index) of the
      facial surface of three maxillary teeth, the lingual surface of the two posterior mandibular
      teeth, and the labial surface of one anterior mandibular tooth were calculated (OHIS, Greene
      & Vermillion, 1962) and the Gingival index of all teeth (Loe and Silness 1963) were recorded
      at the initial appointment (baseline) in the morning. All examinations were performed in the
      morning and by the same examiner at all recall visits, as this helps in reducing the risk of
      bias and quantifying the results.

      Following that, subjects were instructed to use miswak toothpaste twice a day for three days.
      Plaque and gingival bleeding scores were evaluated again after 72 hours. The 3 days study
      design was developed by Marchetti et al study the 3-day plaque accumulation model to compare
      the efficiency of essential oil mouthwash with and without alcohol instead of kinds of
      toothpaste. (Marchetti, E. et al., 2011) Another study was performed by Duarte, K. et al. in
      2022 and followed the 3 days plaque accumulation model to compare the efficiency of two
      herbal kinds of toothpaste with closely resembles our study.
    

Intervention name(s): salvadora; Eucalyptus Oil
Intervention type(s): Drug; Drug
Intervention description(s): The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique.; The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique.
Other intervention name(s): Miswak
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The participants were given a dentifrice that had been labeled and tagged with a number. All participants were asked to brush their teeth twice daily with a 1cm line of paste in their respective brushes for two minutes, once in the morning and the other at night, using the modified bass technique. The technique will be demonstrated to the patient and an image of the technique provided to the participants.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: gingivitis; dental plaque; herbal; dentifrice; miswak; eucalyptol