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Differences between two sodium hyaluronate-based submucosal injection materials currently used in Japan based on viscosity analysis.

ABSTRACT: In Japan, two 0.4% sodium hyaluronate (HA)-based submucosal injection materials (SIMs) are currently used in endoscopic submucosal dissection (ESD): MucoUp (HA-Mc) and Ksmart (HA-Ks). HA-Mc and HA-Ks have the same concentration and are, thus, construed by most endoscopists to have no difference. Nevertheless, visual observation conveys the impression that HA-Ks have a higher viscosity than HA-Mc, suggesting that HA-Ks performs better than HA-Mc. This study aimed to examine the differences between HA-Mc and HA-Ks. HA-Ks exhibited higher viscosity due to greater weight-average molecular weight compared with HA-Mc. HA-Ks had significantly greater submucosal elevation height (SEH) than HA-Mc; the SEH of HA-Ks-80% (80% dilution of HA-Ks) was the same as that of HA-Mc. The ESD procedure time was significantly shorter with HA-Ks than with HA-Mc (15.2?±?4.1 vs. 19.5?±?5.9; P?=?0.049). The total injection volume for HA-Ks was significantly lower than that for HA-Mc (10.8?±?3.6 vs. 14.4?±?4.6; P?=?0.045). However, no significant difference in these items was observed between HA-Mc and HA-Ks-80%. HA-Mc and HA-Ks were considered to be almost the same. Nonetheless, HA-Ks exhibited higher viscosity and SIM performance than HA-Mc. HA-Ks-80% had almost the same performance as HA-Mc. Thus, understanding SIM performance and characteristics requires a focus on the viscosity of SIMs.

SUBMITTER: Hirose R

PROVIDER: S-EPMC7952736 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Differences between two sodium hyaluronate-based submucosal injection materials currently used in Japan based on viscosity analysis.

Hirose Ryohei R Yoshida Takuma T Naito Yuji Y Watanabe Naoto N Hashimoto Hikaru H Sugino Satoshi S Bandou Risa R Daidoji Tomo T Inoue Ken K Dohi Osamu O Yoshida Naohisa N Nakaya Takaaki T Itoh Yoshito Y

Scientific reports 20210311 1

In Japan, two 0.4% sodium hyaluronate (HA)-based submucosal injection materials (SIMs) are currently used in endoscopic submucosal dissection (ESD): MucoUp (HA-Mc) and Ksmart (HA-Ks). HA-Mc and HA-Ks have the same concentration and are, thus, construed by most endoscopists to have no difference. Nevertheless, visual observation conveys the impression that HA-Ks have a higher viscosity than HA-Mc, suggesting that HA-Ks performs better than HA-Mc. This study aimed to examine the differences betwee ...[more]

PMID: 33707637

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Project description:BackgroundRecent artificial tear preparations have provided 0.2% concentration of sodium hyaluronate. However, no published data exist on their potential superiority against 0.1% in alleviating dry-eye-disease symptoms in cataract extraction surgery.MethodsA total of 180 patients that underwent cataract extraction surgery were randomly divided into 2 groups according to their postoperative regime: Study group (SG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.2% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. Control group (CG) received fixed combination of tobramycin and dexamethasone (FCTD) quid for 3 weeks, and additionally 0.1% sodium hyaluronate provided in the COMOD® device quid for 6 weeks. The following indexes were evaluated at 3 postoperative checkpoints: 1) Surface discomfort index (SDI) which was derived by four direct 10-scale Likert-type questions that were addressed to the patient and pertained to: a) foreign body sensation (FBS), b) blinking discomfort (BD), c) stinging sensation (SS), d) tearing sensation (TS), 2) Tear break-up time (TBUT), 3) Schirmer's test, 4) Central corneal thickness (CCT), and 4) Central Corneal Sensitivity (CCS).ResultsBoth groups showed reduced CCS values at all postoperative examination points; however, SG participants had significantly better CCS (all p < 0.05). SG had better TBUT than CG at the 3rd (p = 0.03) and 6th examination points (p = 0.04). Moreover, SG had better SDI scores at the 3rd (SDI = 9.26 ± 0.55) and 6th weeks (SDI = 9.47 ± 0.48) vs. CG participants (p = 0.03 and p < 0.01, respectively).ConclusionThe increased 0.2% sodium hyaluronate concentration in the artificial tears provided in the COMOD® device seems to address dry-eye-disease symptoms better in patients who underwent phacoemulsification surgery than the 0.1% concentration.Trial registrationClinicalTrials.gov Identifier: NCT03705949 Oct 15, 2018, retrospectively registered.

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).

Dataset Information

Differences between two sodium hyaluronate-based submucosal injection materials currently used in Japan based on viscosity analysis.

Publications

Differences between two sodium hyaluronate-based submucosal injection materials currently used in Japan based on viscosity analysis.

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