Dataset Information

A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model.

ABSTRACT:

Objective

To evaluate plaque removal efficacy of dentifrices containing sodium bicarbonate (NaHCO₃) compared with a non-NaHCO₃ dentifrice after a single-timed brushing.

Materials and methods

A randomised, controlled, examiner-blinded, four-period, crossover study in 56 adults with a mean whole-mouth plaque index of ≥2.00 (six site modification of Turesky modification of Quigley-Hein Plaque Index [TPI]). Subjects brushed once for one timed minute with a 67% NaHCO₃ dentifrice with herbs; a 67% NaHCO₃ dentifrice without herbs; a 62% NaHCO₃ dentifrice with herbs; or a non-NaHCO₃ dentifrice without herbs. All contained 923 p.p.m. fluoride as sodium fluoride. Pre- and post-brushing plaque assessments were performed.

Results

Mean TPI score decreased from pre- to post-brushing with all treatments. There were statistically significantly greater reductions in plaque for NaHCO₃ dentifrices compared to non-NaHCO₃ (p < 0.0001 for all) with no significant differences between NaHCO₃-containing dentifrices. A post hoc analysis of plaque removal from different oral areas showed statistically significant differences in favour of the NaHCO₃ dentifrices over the non-NaHCO₃ dentifrice for almost all surfaces. No adverse events were reported.

Discussion and conclusion

Plaque removal was significantly greater with NaHCO₃-containing dentifrices compared with a non-NaHCO₃ dentifrice after a single, timed brushing. There was no effect of herbal tinctures. This study was registered at ClincalTrials.org: NCT03285984.

SUBMITTER: Bosma ML

PROVIDER: S-EPMC5986814 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model.

Bosma Mary-Lynn ML Milleman Kimberly R KR Akwagyiram Ivy I Targett Darren D Milleman Jeffery L JL

BDJ open 20180604

<h4>Objective</h4>To evaluate plaque removal efficacy of dentifrices containing sodium bicarbonate (NaHCO<sub>3</sub>) compared with a non-NaHCO<sub>3</sub> dentifrice after a single-timed brushing.<h4>Materials and methods</h4>A randomised, controlled, examiner-blinded, four-period, crossover study in 56 adults with a mean whole-mouth plaque index of ≥2.00 (six site modification of Turesky modification of Quigley-Hein Plaque Index [TPI]). Subjects brushed once for one timed minute with a 67% Na ...[more]

PMID: 29971158

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Project description:ObjectiveThe objective of this study was to investigate the antigingivitis and antiplaque treatment effect of a toothpaste containing 67% w/w sodium bicarbonate, at the individual tooth site, tooth region and whole mouth (overall) level, by way of a pooled analysis of data from similarly designed clinical trials.MethodsSix randomized controlled GSKCH clinical trials, 12-24 weeks in duration, were selected based on pre-specified criteria which included access to patient level data, pre-treatment dental prophylaxis, >20 bleeding sites and mild-moderate gingivitis at screening and use of 67% sodium bicarbonate toothpaste and non-sodium bicarbonate (regular) toothpaste (negative control) for ≥4 weeks. Efficacy outcomes comprised plaque index (TPI), modified gingival index (MGI) and gingival bleeding (bleeding index (BI), number of bleeding sites (BS)). Treatment comparisons were made using ANCOVA for whole mouth (overall) scores and by tooth site region (facial overall, lingual overall; margin/body overall, facial margin/body, lingual margin/body; papillae/interproximal overall, facial papillae/interproximal, lingual papillae/interproximal). Pooled data for BI, MGI, and TPI at individual tooth sites was plotted as a mouthmap to summarize treatment response (change from baseline) by tooth site, at the 24-week timepoint.ResultsFor all measures, whole mouth and for all tooth regions at all post-treatment timepoints, significant (p < 0.001) differences in favour of the 67% sodium bicarbonate toothpaste compared with control were observed. At the 24-week timepoint, facial regions demonstrated greater improvements than lingual regions, with the greatest between treatment improvement seen for the facial-papillae regions for bleeding (BS/BI), facial-margin regions for MGI and facial-body regions for TPI. All individual tooth sites demonstrated numerically greater reductions from baseline for the 67% sodium bicarbonate toothpaste than the control toothpaste following 24 weeks use, with the greatest improvements (change from baseline) seen for posterior and papillae tooth sites for bleeding, margin tooth sites for MGI and body tooth sites for TPI.ConclusionThis pooled analysis of patient level-data, limited to GSKCH long-term gingivitis clinical studies, demonstrates that twice daily use of a 67% sodium bicarbonate toothpaste effectively removes plaque from all tooth sites, and results in clinically significant improvements in measures of gingival health, overall and for all the tooth regions investigated, compared with a non-sodium bicarbonate (regular) toothpaste following 24 weeks twice daily use.

Project description:BackgroundGingivitis 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).MethodsThis 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.ResultsIn 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.ConclusionsBoth 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 registrationClinicalTrials.gov Identifier: NCT04737538 (04/02/2021).

Project description:RationaleSalt sensitivity of blood pressure affects >30% of the hypertensive and >15% of the normotensive population. Variants of the electrogenic sodium bicarbonate cotransporter NBCe2 gene, SLC4A5, are associated with increased blood pressure in several ethnic groups. SLC4A5 variants are also highly associated with salt sensitivity, independent of hypertension. However, little is known about how NBCe2 contributes to salt sensitivity, although NBCe2 regulates renal tubular sodium bicarbonate transport. We hypothesized that SLC4A5 rs10177833 and rs7571842 increase NBCe2 expression and human renal proximal tubule cell (hRPTC) sodium transport and may be a cause of salt sensitivity of blood pressure.ObjectiveTo characterize the hRPTC ion transport of wild-type (WT) and homozygous variants (HV) of SLC4A5.Methods and resultsThe expressions of NBCe2 mRNA and protein were not different between hRPTCs carrying WT or HV SLC4A5 before or after dopaminergic or angiotensin (II and III) stimulation. However, luminal to basolateral sodium transport, NHE3 protein, and Cl-/HCO3- exchanger activity in hRPTCs were higher in HV than WT SLC4A5. Increasing intracellular sodium enhanced the apical location of NBCe2 in HV hRPTCs (4.24±0.35% to 11.06±1.72% (P<0.05, N = 3, 2-way ANOVA, Holm-Sidak test)) as determined by Total Internal Reflection Fluorescence Microscopy (TIRFM). In hRPTCs isolated from kidney tissue, increasing intracellular sodium enhanced bicarbonate-dependent pH recovery rate and increased NBCe2 mRNA and protein expressions to a greater extent in HV than WT SLC4A5 (+38.00±6.23% vs HV normal salt (P<0.01, N = 4, 2-way ANOVA, Holm-Sidak test)). In hRPTCs isolated from freshly voided urine, bicarbonate-dependent pH recovery was also faster in those from salt-sensitive and carriers of HV SLC4A5 than from salt-resistant and carriers of WT SLC4A5. The faster NBCe2-specific bicarbonate-dependent pH recovery rate in HV SCL4A5 was normalized by SLC4A5- but not SLC4A4-shRNA. The binding of purified hepatocyte nuclear factor type 4A (HNF4A) to DNA was increased in hRPTCs carrying HV SLC4A5 rs7571842 but not rs10177833. The faster NBCe2-specific bicarbonate-dependent pH recovery rate in HV SCL4A5 was abolished by HNF4A antagonists.ConclusionNBCe2 activity is stimulated by an increase in intracellular sodium and is hyper-responsive in hRPTCs carrying HV SLC4A5 rs7571842 through an aberrant HNF4A-mediated mechanism.

Project description:ObjectivesIntervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. We determined the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB).Design and methods15 physically active males (age 25±4 y; body mass 76.0±7.3 kg; height 1.77±0.05 m) completed six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1BM of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate were determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) was recorded as the exercise outcome.ResultsSB supplementation increased blood pH, bicarbonate and base excess prior to every trial (all p ≤ 0.001); absolute changes in pH, bicarbonate and base excess from baseline to pre-exercise were similar in all SB trials (all p > 0.05). Blood lactate was elevated following exercise in all trials (p ≤ 0.001), and was higher in some, but not all, SB trials compared to PL. TWD was not significantly improved with SB vs. PL in any trial (SB1: +3.6%; SB2 +0.3%; SB3: +2.1%; SB4: +6.7%; all p > 0.05), although magnitude-based inferences suggested a 93% likely improvement in SB4. Individual analysis showed ten participants improved in at least one SB trial above the normal variation of the test although five improved in none.ConclusionsThe mechanism for improved exercise with SB was consistently in place prior to exercise, although this only resulted in a likely improvement in one trial. SB does not consistently improve high intensity cycling capacity, with results suggesting that caution should be taken when interpreting the results from single trials as to the efficacy of SB supplementation.Trial registrationClinicalTrials.gov NCT02474628.

Project description:Clinical studies on the efficacy of sonic toothbrushes show inconsistent results, most studies have been conducted without sufficient supervision of appropriate toothbrush usage. Aims of the explorative clinical trial were therefore to investigate whether the usage of an activated sonic toothbrush reduces plaque more effectively than an inactivated one used as a manual toothbrush, and to which extent the correct use of such toothbrush plays a role in its efficacy. The clinical trial was designed as a video-controlled interventional study. Thirty participants (mean (±SD) age 22.9 (±2.5) years) were included, areas of interest were the buccal surfaces of the upper premolars and the first molar (partial mouth recording). Toothbrushing was performed without toothpaste in a single brushing exercise under four different conditions: switched off, habitually used as manual toothbrush, no instruction; switched on, habitually used as powered toothbrush, no instruction; switched off, used as manual toothbrush, instruction in the Modified Bass Technique; switched on, used as powered toothbrush, instruction in a specific technique for sonic toothbrushes. Brushing performance was controlled by videotaping, plaque was assessed at baseline (after 4 days without toothbrushing) using the Rustogi modified Navy-Plaque-Index and planimetry. Main study results were that plaque decreased distinctly after habitual brushing regardless of using the sonic brush in ON or OFF mode (p for all comparisons < 0.001). After instruction, participants were able to use the sonic brush in ON mode as intended, with only minor impact on efficacy. Using the toothbrush in OFF mode with the Modified Bass Technique was significantly less effective than all other conditions (p for all comparisons < 0.001). Under the conditions used, the sonic toothbrush was not more effective when switched on than when switched off, and there was no evidence that the correct use of the toothbrush was more effective than the habitual use.

Dataset Information

A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model.

Objective

Materials and methods

Results

Discussion and conclusion

Publications

A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model.

Similar Datasets

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