Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis.
Gingivitis
Plaque
Sodium bicarbonate
Sodium hyaluronate
Toothpaste
Journal
BMC oral health
ISSN: 1472-6831
Titre abrégé: BMC Oral Health
Pays: England
ID NLM: 101088684
Informations de publication
Date de publication:
09 Feb 2024
09 Feb 2024
Historique:
received:
10
02
2023
accepted:
04
02
2024
medline:
10
2
2024
pubmed:
10
2
2024
entrez:
9
2
2024
Statut:
epublish
Résumé
Gingivitis is driven by plaque accumulation and, if left untreated, can progress to irreversible periodontitis. For many, the mechanical action of toothbrushing does not achieve adequate plaque control. The aim of this study was to investigate whether twice-daily use of a toothpaste containing 0.2% high molecular weight (HMW) sodium hyaluronate with 67% sodium bicarbonate and 0.221% sodium fluoride (experimental toothpaste) could improve gingival health compared with a regular fluoride toothpaste (negative control). The study also assessed whether the experimental toothpaste could provide additive gingival health benefit over a toothpaste containing only 67% sodium bicarbonate and 0.221% sodium fluoride (positive control). This was a single-center, examiner-blinded, randomized, clinical study in healthy adults with mild-to-moderate gingivitis. At baseline, after abstaining from toothbrushing for 12 h, prospective participants underwent oral soft tissue (OST) and oral hard tissue examination followed by assessments for gingival inflammation (Modified Gingival Index [MGI]), gingival bleeding (Bleeding Index [BI]), and supra-gingival plaque (Turesky Plaque Index [TPI]). Eligible participants were stratified by gender and baseline number of bleeding sites (low: <45; high: ≥45 bleeding sites). Following randomization, participants underwent prophylactic dental treatment. Participants received a full OST examination, MGI, BI and TPI assessments after 3 days, 1, 2 and 6 weeks of product use. In total, 110 participants were screened for study entry and all were randomized to receive one of three toothpastes (experimental: sodium hyaluronate, sodium bicarbonate, sodium fluoride; positive control: sodium bicarbonate, sodium fluoride; negative control: regular fluoride toothpaste). For all measures, significant improvements were observed in participants receiving either sodium bicarbonate-containing toothpaste (experimental or positive control) compared with the regular fluoride toothpaste (negative control) at week 6. No significant difference was observed in any assessment or visit comparing the experimental toothpaste with the positive control. Both the experimental and the positive control toothpastes demonstrated clinically relevant improvements in gingival health compared with a regular fluoride toothpaste (negative control). However, no additional gingival health improvement was observed for the experimental toothpaste compared with the positive control, therefore, no additional gingival health benefit can be attributed to the inclusion of sodium hyaluronate in this formulation. ClinicalTrials.gov Identifier: NCT04737538 (04/02/2021).
Sections du résumé
BACKGROUND
BACKGROUND
Gingivitis is driven by plaque accumulation and, if left untreated, can progress to irreversible periodontitis. For many, the mechanical action of toothbrushing does not achieve adequate plaque control. The aim of this study was to investigate whether twice-daily use of a toothpaste containing 0.2% high molecular weight (HMW) sodium hyaluronate with 67% sodium bicarbonate and 0.221% sodium fluoride (experimental toothpaste) could improve gingival health compared with a regular fluoride toothpaste (negative control). The study also assessed whether the experimental toothpaste could provide additive gingival health benefit over a toothpaste containing only 67% sodium bicarbonate and 0.221% sodium fluoride (positive control).
METHODS
METHODS
This was a single-center, examiner-blinded, randomized, clinical study in healthy adults with mild-to-moderate gingivitis. At baseline, after abstaining from toothbrushing for 12 h, prospective participants underwent oral soft tissue (OST) and oral hard tissue examination followed by assessments for gingival inflammation (Modified Gingival Index [MGI]), gingival bleeding (Bleeding Index [BI]), and supra-gingival plaque (Turesky Plaque Index [TPI]). Eligible participants were stratified by gender and baseline number of bleeding sites (low: <45; high: ≥45 bleeding sites). Following randomization, participants underwent prophylactic dental treatment. Participants received a full OST examination, MGI, BI and TPI assessments after 3 days, 1, 2 and 6 weeks of product use.
RESULTS
RESULTS
In total, 110 participants were screened for study entry and all were randomized to receive one of three toothpastes (experimental: sodium hyaluronate, sodium bicarbonate, sodium fluoride; positive control: sodium bicarbonate, sodium fluoride; negative control: regular fluoride toothpaste). For all measures, significant improvements were observed in participants receiving either sodium bicarbonate-containing toothpaste (experimental or positive control) compared with the regular fluoride toothpaste (negative control) at week 6. No significant difference was observed in any assessment or visit comparing the experimental toothpaste with the positive control.
CONCLUSIONS
CONCLUSIONS
Both the experimental and the positive control toothpastes demonstrated clinically relevant improvements in gingival health compared with a regular fluoride toothpaste (negative control). However, no additional gingival health improvement was observed for the experimental toothpaste compared with the positive control, therefore, no additional gingival health benefit can be attributed to the inclusion of sodium hyaluronate in this formulation.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT04737538 (04/02/2021).
Identifiants
pubmed: 38336635
doi: 10.1186/s12903-024-03981-9
pii: 10.1186/s12903-024-03981-9
doi:
Banques de données
ClinicalTrials.gov
['NCT04737538']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
209Informations de copyright
© 2024. The Author(s).
Références
Oral Disorders GBD, Collaborators, Bernabe E, Marcenes W, Hernandez CR, et al. Global, regional, and national levels and trends in burden of oral conditions from 1990 to 2017: a systematic analysis for the global burden of Disease 2017 study. J Dent Res. 2020;S99(4):362–73.
Kinane DF, Hodge PJ. Periodontal disease in children and adolescents: introduction and classification. Periodontol. 2000. 2001;26:7–15.
Davies RM. Toothpaste in the control of plaque/gingivitis and periodontitis. Periodontol 2000. 2008;48:23–30.
doi: 10.1111/j.1600-0757.2008.00261.x
pubmed: 18715353
Chapple IL, Van der Weijden F, Doerfer C, et al. Primary prevention of periodontitis: managing gingivitis. J Clin Periodontol. 2015;42(Suppl 16):71–6.
Brook I. Microbiology and management of periodontal infections. Gen Dent. 2003;51(5):424–8.
pubmed: 15055631
Ower P. The role of self-administered plaque control in the management of periodontal diseases: I. A review of the evidence. Dent Update. 2003;30(2):60–4. 66, 68.
doi: 10.12968/denu.2003.30.2.60
pubmed: 12705026
Petersen PE, Ogawa H. The global burden of periodontal disease: towards integration with chronic disease prevention and control. Periodontol 2000. 2012;60(1):15–39.
doi: 10.1111/j.1600-0757.2011.00425.x
pubmed: 22909104
Worthington HV, MacDonald L, Poklepovic Pericic T, et al. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019;4(4):CD012018.
pubmed: 30968949
Shamsoddin E. Dental floss as an adjuvant of the toothbrush helps gingival health. Evid Based Dent. 2022;23(3):94–6.
doi: 10.1038/s41432-022-0818-x
pubmed: 36151277
Saxer U, Jaschouz V, Ley F. The effect of parodontax dentifrice on gingival bleeding. J Clin Dent. 1994;5(2):63–4.
pubmed: 7999291
Saxer UP, Menghini G, Bohnert KJ, Ley F. The effect of two toothpastes on plaque and gingival inflamation. J Clin Dent. 1995;6(2):154–6.
pubmed: 8624228
Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-month evaluation of a sodium bicarbonate-containing toothpaste for reduction of established gingivitis: a randomized USA-based clinical trial. J Clin Dent. 2018;29(1):33–9.
pubmed: 29758155
Akwagyiram I, Amini P, Bosma ML, Wang N, Gallob J. Efficacy and tolerability of sodium bicarbonate toothpaste in subjects with gingivitis: a 6-month randomized controlled study. Oral Health Prev Dent. 2018;16(5):401–7.
pubmed: 30460353
Parkinson CR, Butler A, Ling MR. Antigingivitis efficacy of a sodium bicarbonate toothpaste: pooled analysis. Int J Dent Hyg. 2023;21(1):106–15.
doi: 10.1111/idh.12626
pubmed: 36106361
Putt MS, Milleman KR, Ghassemi A, et al. Enhancement of plaque removal efficacy by tooth brushing with baking soda dentifrices: results of five clinical studies. J Clin Dent. 2008;19(4):111–9.
pubmed: 19278079
Bosma ML, Milleman KR, Akwagyiram I, Targett D, Milleman JL. A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model. BDJ Open. 2018;4:17037.
doi: 10.1038/s41405-018-0003-7
pubmed: 29971158
pmcid: 5986814
Mason S, Karwal R, Bosma ML. Two randomized clinical studies to confirm differential plaque removal by sodium bicarbonate dentifrices in a single timed brushing model. J Clin Dent. 2017;28(3):44–8.
pubmed: 29211950
Valkenburg C, Kashmour Y, Dao A, Van der Fridus GA, Slot DE. The efficacy of baking soda dentifrice in controlling plaque and gingivitis: a systematic review. Int J Dent Hyg. 2019;17(2):99–116.
doi: 10.1111/idh.12390
pubmed: 30734996
pmcid: 6850485
Taschieri S, Tumedei M, Francetti L, Corbella S, Del Fabbro M. Efficacy of 67% sodium bicarbonate toothpaste for plaque and gingivitis control: a systematic review and meta-analysis. J Evidence-Based Dent Pract. 2022;22(2):101709.
doi: 10.1016/j.jebdp.2022.101709
Pratten J, Wiecek J, Mordan N, et al. Physical disruption of oral biofilms by sodium bicarbonate: an in vitro study. Int J Dent Hyg. 2016;14(3):209–14.
doi: 10.1111/idh.12162
pubmed: 26198308
Al-Khateeb R, Olszewska-Czyz I. Biological molecules in dental applications: hyaluronic acid as a companion biomaterial for diverse dental applications. Heliyon. 2020;6(4):e03722.
doi: 10.1016/j.heliyon.2020.e03722
pubmed: 32280803
pmcid: 7139111
Dahiya P, Kamal R. Hyaluronic acid: a boon in periodontal therapy. N Am J Med Sci. 2013;5(5):309–15.
doi: 10.4103/1947-2714.112473
pubmed: 23814761
pmcid: 3690787
Dovedytis M, Liu ZJ, Bartlett S. Hyaluronic acid and its biomedical applications: a review. Eng Regeneration. 2020;1:102–13.
doi: 10.1016/j.engreg.2020.10.001
Rajan P, Baramappa R, Rao NM, Pavaluri AK, Indeevar I, Rahaman SM. Hyaluronic acid as an adjunct to scaling and root planing in chronic periodontitis. A randomized clinical trail. J Clin Diagn Res. 2014;8(12):ZC11–14.
pubmed: 25654021
pmcid: 4316327
Dechert TA, Ducale AE, Ward SI, Yager DR. Hyaluronan in human acute and chronic dermal wounds. Wound Repair Regen. 2006;14(3):252–8.
doi: 10.1111/j.1743-6109.2006.00119.x
pubmed: 16808803
Romano CL, De Vecchi E, Bortolin M, Morelli I, Drago L. Hyaluronic acid and its composites as a local antimicrobial/antiadhesive barrier. J Bone Jt Infect. 2017;2(1):63–72.
doi: 10.7150/jbji.17705
pubmed: 28529865
pmcid: 5423572
Drago L, Cappelletti L, De Vecchi E, Pignataro L, Torretta S, Mattina R. Antiadhesive and antibiofilm activity of hyaluronic acid against bacteria responsible for respiratory tract infections. APMIS. 2014;122(10):1013–9.
doi: 10.1111/apm.12254
pubmed: 24698341
Jain Y. Clinical evaluation of 0.2% hyaluronic acid containing gel in the treatment of gingivitis. Med J DY Patil Vidyapeeth. 2016;6(4):416–20.
doi: 10.4103/0975-2870.118296
Jentsch H, Pomowski R, Kundt G, Gocke R. Treatment of gingivitis with hyaluronan. J Clin Periodontol. 2003;30(2):159–64.
doi: 10.1034/j.1600-051X.2003.300203.x
pubmed: 12622859
Sapna N, Vandana KL. Evaluation of hyaluronan gel (Gengigel(®) as a topical applicant in the treatment of gingivitis. J Investig Clin Dent. 2011;2(3):162–70.
doi: 10.1111/j.2041-1626.2011.00064.x
pubmed: 25426786
Sahayata VN, Bhavsar NV, Brahmbhatt NA. An evaluation of 0.2% hyaluronic acid gel (Gengigel (®) in the treatment of gingivitis: a clinical & microbiological study. Oral Health Dent Manag. 2014;13(3):779–85.
pubmed: 25284557
Hussien AK, Mohammed A-SAN, Al-Fatlawi ZM, Jawad QAM. Clinical evaluation of 0.2% hyaluronic acid and its effect on periodontal parameters before and after treatment of plaque induced gingivitis. J Pharm Sci Res. 2019;11(2):450–2.
Al-Shabeeb AKH, Mohammed AN. Clinical evaluation of 0.2% hyaluronic acid and its effect on the level of interleukine-1β in gingival crevicular fluid before and after treatment of plaque induced gingivitis. IJPHRD. 2019;10(2):659–64.
doi: 10.5958/0976-5506.2019.00368.1
Mesa FL, Aneiros J, Cabrera A, et al. Antiproliferative effect of topic hyaluronic acid gel. Study in gingival biopsies of patients with periodontal disease. Histol Histopathol. 2002;17(3):747–53.
pubmed: 12168783
Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970;41(1):41–3.
doi: 10.1902/jop.1970.41.1.41
pubmed: 5264376
Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989;24(1):75–80.
doi: 10.1111/j.1600-0765.1989.tb00860.x
pubmed: 2524573
Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dentistry. 1986;8(1):3–6.
Gallagher A, Sowinski J, Bowman J, et al. The effect of brushing time and dentifrice on dental plaque removal in vivo. J Dent Hyg. 2009;83(3):111–6.
pubmed: 19723429
Centers for Disease Control and Prevention Periodontal Disease. 2013: Available at: https://www.cdc.gov/oralhealth/conditions/periodontal-disease.html (Accessed May 2023).
Imrey PB, Chilton NW, Pihlstrom BL, et al. Reccomended revisions to American Dental Association guidelines for acceptance of chemotherapeutic products for gingivitis control. J Periodontal Res. 1994;29:299–304.
doi: 10.1111/j.1600-0765.1994.tb01225.x
pubmed: 7932024