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A single-centre investigator-blinded randomised parallel group clinical trial to investigate the effect of probiotic strains Streptococcus salivarius M18 and Lactobacillus acidophilus on gingival health of paediatric patients undergoing treatment with fixed orthodontic appliances: study protocol
  1. Eleftherios G Kaklamanos1,
  2. Rania Nassar2,
  3. Sotirios Kalfas3,
  4. Manal Al Halabi1,
  5. Mawlood Kowash1,
  6. Haifa Hannawi1,
  7. Iyad Hussein1,
  8. Anas Salami1,
  9. Ammar Hassan1,
  10. Abiola C Senok2
  1. 1 Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates
  2. 2 College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates
  3. 3 School of Dentistry, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece
  1. Correspondence to Professor Abiola C Senok; abiola.senok{at}mbru.ac.ae

Abstract

Background There is limited data on the beneficial effects of probiotics on the gingival health of patients undergoing treatment with fixed orthodontic appliances. This study aims to compare the effect of probiotic tablets combined with regular oral hygiene versus regular oral hygiene alone on gingival status in these patients. The effect of probiotic intake on plaque formation and salivary microbiome composition will be also assessed.

Methods and analysis This is a 3 month single-centre, single blind (clinical and laboratory examiners), parallel group randomised controlled two arm superiority trial. Fifty paediatric patients attending the Postgraduate Orthodontic Clinic at the Hamdan Bin Mohammed College of Dental Medicine (HBMCDM), Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, United Arab Emirates, who meet the eligibility criteria will be recruited. Block randomisation with 1:1 allocation and concealment of allocation will be carried out. The treatment group will receive probiotic tablets containing Streptococcus salivarius M18 and Lactobacillus acidophilus together with regular oral hygiene versus the control group on regular oral hygiene alone. Clinical examination and collection of saliva for microbiome assay will be carried out at baseline and end of study. Self-reporting by patients will be used to document acceptability and adverse effects. Statistically significant decrease in gingival bleeding on probing in the treatment group will be classified as primary outcome of treatment success. Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.

Ethics and dissemination Ethical approval for the study has been granted by the HBMCDM, MBRU, Institutional Review Board (Reference #: MBRU-IRB-2018–015). Study findings will be disseminated via publication in peer-reviewed journal.

Trial registration number ISRCTN95085398

  • oral medicine
  • complementary Medicine
  • Clinical trial therapeutics

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors EGK, RN, ACS conceived the study and initiated the study design. EGK, RN, MAH, MK, HH, IH, AS, ACS will be involved in study implementation. AH provided statistical expertise in clinical trial design and will conduct the statistical analysis. SK will provide expertise with data interpretation. EGK, RN, SK, MAH, AH, ACS are grant holders. All authors contributed to finalising the study protocol and approved the final manuscript.

  • Funding The study is fully funded by internal research grant from the Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences (Grant #: MBRU-HBMCDM-RG2017-03). The probiotic product used is locally available and will be bought from the pharmacy independent of the manufacturers.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval for the study has been granted by the Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Institutional Review Board (Reference #: MBRU-IRB-2018–015).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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