NCT04650685

Anti-Plaque and Anti-Gingivitis Effectiveness of the Newly Invented Salvadora Persica Toothbrush Compared to Salvadora Persica Chewing Stick: A Randomised Controlled Trial

Status unknown NA Last updated 4 January 2021

What this trial tests

NA trial testing The novel Salvadora persica toothbrush in Gingivitis in 105 participants. Status unknown.

Timeline

22 December 2020

Primary endpoint
1 August 2021

1 October 2021

Quick facts

Lead sponsor	National University of Malaysia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	105
Start date	22 December 2020
Primary completion	1 August 2021
Estimated completion	1 October 2021
Sites	1 location across Malaysia

Drugs / interventions tested

• The novel Salvadora persica toothbrush
• The Salvadora persica (miswak) chewing stick
• Standard toothbrush and toothpaste (control)

Conditions studied

• Gingivitis — all drugs for Gingivitis →
• Dental Plaque — all drugs for Dental Plaque →

Sponsor

National University of Malaysia

Who can join

18 and older, any sex, with Gingivitis or Dental Plaque. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Probing attachment level
  Time frame: 5 weeks
  Firstly, the periodontal pocket depth (PPD) will be assessed at six points per tooth. The measurement will be performed using a University of North Carolina probe (PCP-UNC 15) probe, which has a clear black coding of every millimetre demarcation that is up to 15 mm length. Then, probing attachment level will be assessed to the nearest millimetre by the same probe and expressed as the distance in
• Gingival Index
  Time frame: 5 weeks
  This implies the gingival status by the examination of the severity of gingival inflammation. In addition, the initiation of bleeding will be noted by gently stroking the entrance to the gingival sulcus with a blunt periodontal probe. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of plaque adhering to the free gingival mar
• Plaque Index
  Time frame: 5 weeks
  Before the presence of dental plaque level is examined, the disclosing solution will be applied on the small cotton swab and then gently dabbed on the tooth surface. The participants will be instructed not to rinse their mouth with water until the examination is completed. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of p

Sponsor's own description

Dental plaque is a main etiologic agent in periodontal disease. Global of Burden Disease Study 2016 ranked periodontal disease as the 11th most prevalent disease affecting 10.5% population worldwide. Tooth brushing is a reliable mechanical means to control dental plaque accumulation in order to maintain oral health. For decades, studies have demonstrated the efficiency of unprocessed Salvadora persica (miswak) chewing stick practice as an alternative to a standard toothbrush. Recently, a local Malaysian company has invented and successfully mass manufactured a world-first Salvadora persica toothbrush where its nylon bristles are primarily mixed with miswak powder and natural silica. With the benefits of Salvadora persica properties intact, it is also claimed to be effective without the application of toothpaste. However, the claim remains to be fully elucidated. There is also no randomized controlled trial available evaluating the efficacy of Salvadora persica toothbrush to date. Therefore, the aim of this study is to evaluate the effectiveness of the newly invented Salvadora persica toothbrush on oral health, particularly on anti-plaque and anti-gingivitis effects. The patient related-outcomes of Salvadora persica on a short-term use will also be assessed. The hypotheses of this study are that Salvadora persica toothbrush does not contribute to the significant effects on oral health and there is no difference in the use of Salvadora persica chewing stick, Salvadora persica toothbrush as well as the standard toothbrush on anti-plaque and anti-gingivitis in a standardized manner. Additionally, a hypothesis that there is no patient-related outcome of Salvadora persica on a short-term use has also been devised. A randomized, single blind, and parallel clinical study will be conducted over a five-week period involving the healthy non-dental students of the National University of Malaysia. This study consists of three groups of different oral hygiene tools: (i) Salvadora persica toothbrush; (ii) Salvadora persica chewing stick; and (iii) Standard toothbrush and toothpaste as control. The primary outcomes of this study are the clinical parameters that will be recorded at four different appointments. Salvadora persica toothbrush is expected to show positive effects to that of standard toothbrush with respect to plaque and gingivitis control. This study is thus designed to provide an insight on Salvadora persica toothbrush as a good preventive home care therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of Salvadora persica toothbrush and Salvadora persica chewing stick in plaque and gingivitis control: a randomized control trial.
   Azizan NF, Mohd N, Nik Azis NM, Baharin B. · · 2023 · cited 7× · PMID 38098022 · DOI 10.1186/s12906-023-04295-z