The caries-protective effect of the peptide P11-4 in home prevention during fixed multi-bracket treatment – a clinical randomized prospective study - P11-4 RCT

开始日期2022-06-23

申办/合作机构-

NCT05667545 / Completed临床1期

Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.

Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues.
These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization.
In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand

开始日期2021-07-01

申办/合作机构

Egymedicalpedia

CTRI/2020/06/026016 / Not yet recruiting临床3期IIT

Remineralization potential of self-assembling peptide P11-4 on early enamel caries in 6 to 8 year old children. A randomized control trial

开始日期2020-07-01

申办/合作机构-

100 项与 Peptide P11-4 相关的临床结果

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100 项与 Peptide P11-4 相关的转化医学

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100 项与 Peptide P11-4 相关的专利（医药）

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项与 Peptide P11-4 相关的文献（医药）

2024-08-22·International Journal of Clinical Pediatric Dentistry

Efficacy of Self-assembling Peptide P11-4 in Remineralizing In Vitro Caries-like Lesions in Primary Enamel Samples in Combination with Calcium Phosphate-based Remineralization Agents

Article

作者: Shanbhag, Raghavendra ; Shanbhog, Raghavendra S ; Godhi, Brinda S ; Krishnamoorthi, Ashwini ; Krishnamoorthi, Ashwini ; Godhi, Brinda S ; Sundaravadivelu, Mirunalini

Aims and backgroundThe efficacy of self-assembling peptide P11-4 in combination with calcium-phosphate-based remineralization agents in remineralizing caries-like lesions in primary enamel was evaluated using a 21-day pH cycling experiment by Vickers microhardness [Vickers hardness number (VHN)] and scanning electron microscopy (SEM).Materials and methodsA total of 120 primary enamel samples were made to undergo a demineralization cycle to produce caries-like lesions. They were divided into six groups, namely negative control (NC), positive control (P11-4), and four interventional groups in which each of the following calcium-phosphate-based agents were used in combination with P11-4-calcium sucrose phosphate (CSP), bioactive glass (BG), casein phosphopeptides, and casein phosphopeptides with fluoride. A 21-day pH cycling experiment was carried out with alternating demineralization and remineralization phases. The enamel samples were analyzed at baseline, post production of caries-like lesions, and post 21-day pH cycling using Vickers microhardness and SEM. Results were statistically analyzed using repeated measures of analysis of variance (ANOVA), keeping the level of significance at 0.05.ResultsSupplementing P11-4 with calcium-phosphate-based agents improved the surface hardness of the demineralized primary enamel samples, among which the fluoridated milk protein-based remineralization agent yielded a statistically significant improvement.ConclusionP11-4 promoted the regeneration of incipient caries-like lesions. However, there is added benefit when this peptide is used in combination with a fluoridated calcium-phosphate-based agent.Clinical significanceThis study would help the clinician compose an effective regimen for the patient to follow at home posttreatment with P11-4, in-office treatment.How to cite this articleKrishnamoorthi A, Shanbhog RS, Godhi BS, et al. Efficacy of Self-assembling Peptide P11-4 in Remineralizing In Vitro Caries-like Lesions in Primary Enamel Samples in Combination with Calcium Phosphate-based Remineralization Agents. Int J Clin Pediatr Dent 2024;17(5):552-557.

2024-01-01·Journal of Conservative Dentistry and Endodontics

Comparative evaluation of remineralization potential of four different remineralization agents on human enamel: An in vitro study

Article

作者: Vivek, V. J. ; Ramakrishnan, Ashish ; Xavier, Giftlin Denny ; Selvam, Kanimozhi ; Thomas, George ; Jose, Sunil

AbstractAim:The study aimed to assess the remineralizing potential of four different commercially available agents using a Scanning Electron Microscope (SEM), energy dispersive X-ray (EDX) analysis, and Vickers Microhardness (VMH) Test.Materials and Methods:Forty-four specimens (n = 11 per group) were prepared from extracted teeth. A window of 6 mm × 4 mm was made on all the specimens that represented three zones, namely, sound enamel, demineralized enamel, and remineralized enamel. The zone for demineralized enamel was subjected to four different remineralizing agents; casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF), tricalcium phosphate fluoride (TCP-F), calcium sucrose phosphate (CSP), and self-assembling peptide (P11-4). Remineralization (REM) was assessed using VMH; the structural changes were assessed using SEM that was analyzed using EDX analysis. The specimens were subjected to a newer regimen of demineralization. One-way ANOVA followed by post hoc Tukey test was used with a level of significance at P ≤ 0.05.Results:There were no significant differences in VMH between the groups for sound enamel (P = 0.472) and demineralized enamel (P = 0.116). VMH was statistically significantly more for P11-4 and the least for CPP-ACPF (P = 0.011). A post hoc analysis revealed higher VMH for P11-4 compared to CPP-ACPF (P = 0.014) and TCP-F (P = 0.035). SEM showed a homogeneous layer of minerals for all groups except CPP-ACPF. TCP-F reported a higher degree of REM, followed by P11-4 as assessed using EDX analysis.Conclusion:Self-assembling peptide (P11-4) exhibited a higher degree of REM than other remineralizing agents followed by CSP.

2023-10-01·European Archives of Paediatric Dentistry

Self-assembling peptides for managing white spot lesions: a systematic review and meta-analysis

Review

作者: Kumar, P ; Chugh, A ; Patnana, A K ; Chugh, V K ; Rathore, K

PURPOSEThe primary objective of the review was to assess the effectiveness of self-assembling P11-4 peptide (SAP) with or without any fluoride agents (FA) in remineralization of the White spot lesions (WSLs)/incipient carious lesions (ICLs) compared to other enamel remineralizing agents/non-intervention/placebo.METHODSHuman RCTs published during the period from 1st January 2000-30th June 2021 were searched in the electronic bibliographic databases and scanning reference lists of articles from PubMed, Google Scholar, and The Cochrane Central Register of Controlled Trials. The Risk-of-Bias was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2) tool for all included studies. The statistical heterogeneity between studies was assessed by the Cochrane Q test and I² test. A random-effects model was used considering the variations in true effects size between the included studies. The quality of the evidence for remineralizing effectiveness of SAP/SAP + FA was done using the GRADEpro GDT software which employs GRADE.RESULTSFour out of eight included trials were assessed to have "high risk" of bias. Mean difference for Laser fluorescence outcome assessment method (SAP v/s FA) was - 4.89 (95% CI: - 17.35 to 7.57; p = 0. 44; I² = 89%). The combined risk ratio observed through Nyvad criteria (SAP v/s FA) was 0.12 (95% CI: 0.01-1.59; p = 0.11; I² = 71%). Mean difference for Laser fluorescence outcome assessment method (SAP + FA v/s FA) was - 11.52 (95% CI: - 14.43 to - 8.61; p = < 0.001;I² = 0%). The combined risk ratio for ICDAS outcome assessment method (SAP + FA v/s FA) was 0.27 (95% CI: 0.03-2.84; p = 0.15; I² = 53%).CONCLUSIONConsidering the results observed from the included trials we are uncertain whether SAP/SAP + FA increases/decreases the remineralizing/regeneration of WSLs/ICLs.

100 项与 Peptide P11-4 相关的药物交易

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