Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial.
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ABSTRACT:
SUBMITTER: Brunton PA
PROVIDER: S-EPMC3813405 | biostudies-other | 2013 Aug
REPOSITORIES: biostudies-other
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Project description:The aim was to investigate the ability of self-assembling Peptide P11-4 Matrix (SAPM) to remineralize artificial initial caries lesions compared to the use of fluoride varnish. Volunteers were recruited for this randomised, cross-over in situ trial. Bovine specimens, half including orthodontic brackets, were recessed on the buccal aspects of mandibular appliances. Specimens included internal sound enamel control, a demineralised control and a part exposed during the in situ phase. Each phase lasted four weeks, followed by a one-week washout. Treatment groups were: A: negative control, no treatment,B: positive control, 22,600 ppm fluoride varnish,C: test group, 1,000 ppm SAPM. Laser fluorescence values (LF) were measured before/after demineralisation, and after the in situ period. Micro-CT analysis was used to assess mineral changes within the specimens after the in situ phase. In specimens without brackets, ?LF values after in situ phase were: A: +5.28, B: +0.85, C: -2.89. Corresponding ?LF for specimens with brackets were: A: +5.77, B: +1.30, C: -3.15. LF-values between groups significantly differed from each other (p?<?0.0001) after the in situ phase. Micro-CT analysis yielded no significant difference among groups for specimens without brackets. For specimens with brackets, the test group showed significantly more remineralisation than the negative (p?=?0.01) and positive control (p?=?0.003). Within the limitations of the study, SAPM showed prevention of caries and remineralisation of enamel around orthodontic brackets.
| S-EPMC6343002 | biostudies-literature
Project description:Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P11-4 (SAP P11-4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P11-4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P11-4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P11-4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.
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Project description:BackgroundNanoparticles and regenerative biomineralization are new caries prevention technologies. This study assessed the remineralizing effect of self-assembling peptide (P11-4), Nanosilver Fluoride (NSF) and sodium fluoride (NaF) on white spot lesions (WSLs) in permanent teeth.MethodsSixty six young adults with WSLs on buccal surfaces in permanent teeth and ICDAS code 1 or 2, were randomly assigned to one of three groups; P11-4, NSF or NaF. Assessment of ICDAS scores, lesion activity (Nyvad scores) and diagnodent readings of lesions were done at baseline and after 1, 3, 6 and 12 months of agents' application. Comparisons between groups were made using chi squared test and comparison within groups were made using McNemar test. Multilevel binary logistic regression was used to assess the effect of agents on change of ICDAS scores after 3, 6 and 12 months (reduction versus no reduction).ResultsThere were 147 teeth in 66 patients; mean ± SD age = 13.46 ± 4.31 years. There were significant differences in the change of ICDAS scores among the three groups after 3 and 6 months (p = 0.005). The reduction in ICDAS score increased steadily in all groups across time with the greatest increase in the P11-4 group: 54.5% after 12 months. Lesion activity (Nyvad scores) showed significant differences among the three groups with the greatest percentage of inactive cases in the P11-4 group. Multilevel binary logistic regression showed non-significant reduction of ICDAS in P11-4 and NSF varnishes compared to NaF varnish (AOR = 2.56, 95% CI: 0.58, 8.77 and AOR = 2.12, 95% CI: 0.59, 7.64 respectively).ConclusionP11-4 and NSF varnish reduced the ICDAS scores, caries activity and diagnodent readings of WSLs in permanent teeth. However, the change in ICDAS scores was not significantly different from NaF.Trial registrationThis trial was prospectively registered on the clinicaltrials.gov registry with ID: NCT04929509 on 18/6/2021.
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Project description:Self-assembling peptides are a type of biomaterial rapidly emerging in the fields of biomedicine and material sciences due to their promise in biocompatibility and effectiveness at controlled release. These self-assembling peptides can form diverse nanostructures in response to molecular interactions, making them versatile materials. Once assembled, the peptides can mimic biological functions and provide a combinatorial delivery of therapeutics such as cytokines and drugs. These self-assembling peptides are showing success in biomedical settings yet face unique challenges that must be addressed to be widely applied in the clinic. Herein, we describe self-assembling peptides' characteristics and current applications in immunomodulatory therapeutics.
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Project description:Self-assembling peptides (SAPs) have gained significant attention in biomedicine because of their unique properties and ability to undergo molecular self-assembly driven by non-covalent interactions. By manipulating their composition and structure, SAPs can form well-ordered nanostructures with enhanced selectivity, stability and biocompatibility. SAPs offer advantages such as high chemical and biological diversity and the potential for functionalization. However, studies concerning its potentially toxic effects are very scarce, a limitation that compromises its potential translation to humans. This study investigates the potentially toxic effects of six different SAP formulations composed of natural amino acids designed for nervous tissue engineering and amenable to ready cross-linking boosting their biomechanical properties. All methods were performed in accordance with the relevant guidelines and regulations. A wound-healing assay was performed to evaluate how SAPs modify cell migration. The results in vitro demonstrated that SAPs did not induce genotoxicity neither skin sensitization. In vivo, SAPs were well-tolerated without any signs of acute systemic toxicity. Interestingly, SAPs were found to promote the migration of endothelial, macrophage, fibroblast, and neuronal-like cells in vitro, supporting a high potential for tissue regeneration. These findings contribute to the development and translation of SAP-based biomaterials for biomedical applications.
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Project description:To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency.As part of the Xylitol for Adult Caries Trial (X-ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic.The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit.There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol.ClinicalTrials.Gov NCT00393055.
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