Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries.
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PROVIDER: S-EPMC7060217 | BioStudies |
REPOSITORIES: biostudies
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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
Project description:To investigate the safety and efficacy of Self-Assembling Peptide P11-4 (SAP P11-4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P11-4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P11-4 lesions (test, D90-D0) showed significant WSL size reduction compared to placebo (control, D90-D0; p?=?0.008) or FV (control, D180-D90; p?=?0.001). Combination of SAP P11-4 and delayed FV after 90 days (test, D180-D0), showed a significant difference compared to FV alone (control D270-D90; p?=?0.003). No significant difference on FV efficacy was found when SAP P11-4 was applied 3 months before FV (test D270-D90; control D270-D90, p?=?0.70). SAP P11-4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P11-4. SAP P11-4 was found to be a safe and effective WSL treatment.
| S-EPMC7678830 | BioStudies
Project description:Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P11-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P11-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P11-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P11-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs ( ClinicalTrials.gov NCT02724592).
| S-EPMC6429572 | BioStudies
Project description:To determine the efficacy of fluoride varnish (5% NaF, Duraphat, Colgate) added to caregiver counseling to prevent early childhood caries, we conducted a two-year randomized, dental-examiner-masked clinical trial. Initially, 376 caries-free children, from low-income Chinese or Hispanic San Francisco families, were enrolled (mean age +/- standard deviation, 1.8 +/- 0.6 yrs). All families received counseling, and children were randomized to the following groups: no fluoride varnish, fluoride varnish once/year, or fluoride varnish twice/year. An unexpected protocol deviation resulted in some children receiving less active fluoride varnish than assigned. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, p < 0.01. Analyzing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, p < 0.01. Caries incidence was higher for 'counseling only' vs. 'counseling + fluoride varnish assigned once/year' (OR = 2.20, 95% CI 1.19-4.08) and 'twice/year' (OR = 3.77, 95% CI 1.88-7.58). No related adverse events were reported. Fluoride varnish added to caregiver counseling is efficacious in reducing early childhood caries incidence.
| S-EPMC2257982 | BioStudies
Project description:The aim of this trial was to determine whether a toothpaste with microcrystalline hydroxyapatite is not inferior to a fluoride toothpaste in prevention of caries in children. This double-blinded randomized control trial compared two toothpastes regarding the occurrence of caries lesions using International Caries Detection and Assessment System (ICDAS)???code 1 on the primary dentition within 336 days. The test group used a fluoride-free hydroxyapatite toothpaste three times daily while control group used a toothpaste with fluoride. 207 children were included in the intention-to-treat analysis; 177 of them finished the study per protocol. An increase in caries ICDAS???code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n?=?88), compared with 74.2% of the fluoride-group (n?=?89). The exact one-sided upper 95% confidence limit for the difference in proportion of participants with ICDAS increase???1 (-1.4%) was 9.8%, which is below the non-inferiority margin of 20% demonstrating non-inferiority of hydroxyapatite compared to the fluoride control toothpaste. This RCT showed for the first time, that in children, the impact of the daily use of a toothpaste with microcrystalline hydroxyapatite on enamel caries progression in the primary dentition is not inferior to a fluoride control toothpaste (Clinical Trials NCT03553966).
| S-EPMC7846568 | BioStudies
Project description:Fissure sealant is a recommended preventive measure on permanent molars, but its efficacy on primary molars in preschool children is still in doubt. Sodium fluoride varnish (NaFV) enhances remineralization and is effective in preventing caries in smooth surfaces, but limited information is available regarding its use on occlusal surfaces of primary molars. The present study aimed to compare the efficacy of glass ionomer sealant (GIS) versus topical application of 5% NaFV in preventing and arresting occlusal caries in primary second molars among preschool children. One calibrated examiner examined children aged 3-4 years for visible plaque index (VPI), decayed-missing-filled primary surface (dmfs) index, and extent of carious lesions by the International Caries Detection and Assessment System (ICDAS). Subjects with 1 or more primary second molars that were sound or with incipient lesions (ICDAS 0-1), with distinct visual enamel changes (ICDAS 2), or with localized enamel breakdown (ICDAS 3) were recruited. The children were randomly assigned to either NaFV group - application of 5% NaFV at 3-monthly intervals or GIS group - 1 single placement of GIS. A parental questionnaire was used to collect information on the children's sociodemographic background and oral health-related habits. Two blinded examiners conducted clinical examinations after 6 and 12 months to evaluate the development of occlusal caries and the retention of GIS. Negative binomial regression using generalized estimating equations was employed to adjust for the clustering effect and evaluate the influence of selected variables on the development of occlusal caries into dentin at 12 months. A total of 323 children with 1,159 primary second molars received the respective preventive measures at baseline. At 12 months, 280 children with 989 molars were evaluated. Caries had developed or progressed into dentin in 7.8% and 8.0% of the molars in the NaFV and GIS groups, respectively, with no significant difference between the groups (p = 0.913). The overall retention rates of GIS were 24.6% and 13.5% at 6 and 12 months, respectively. Regression analyses showed only baseline caries experience, and an ICDAS code had a significant association with occlusal caries progression. Quarterly NaFV application and single GIS placement showed similar effectiveness in the prevention of occlusal caries development among preschool children.
| S-EPMC8491493 | BioStudies
Project description:AIM:The aim of the present randomized, controlled trial was to compare the impact of the regular use of a fluoride-free microcrystalline hydroxyapatite (HAP) dentifrice and a 1400 ppm fluoride control dentifrice on caries progression in 150 highly caries-active orthodontic patients. METHODS:The primary outcome was the occurrence of lesions with International Caries Detection and Assessment System (ICDAS) ?code 1 on the vestibular surfaces of teeth 15-25 within 168 days after fixation of orthodontic brackets. Secondary outcomes were lesion development ICDAS ?code 2, the plaque index, and the gingival index. RESULTS:In total, 147 patients were included in the intent-to-treat (ITT) analysis; 133 finished the study per protocol (PP). An increase in enamel caries ICDAS ?code 1 was observed in 56.8% (ITT) and 54.7% (PP) of the HAP group participants compared with 60.9% (ITT) and 61.6% (PP) of the fluoride control group. Non-inferiority testing (ITT and PP) demonstrated the absence of a significant difference between the groups. No significant differences in secondary outcomes were observed between the groups. CONCLUSION:In highly caries-active patients, the impact of the regular use of a microcrystalline HAP dentifrice on caries progression is not significantly different from the use of a 1400 ppm fluoride toothpaste (ClinicalTrials.gov: NCT02705456).
| S-EPMC6590169 | BioStudies
Project description:<h4>Objective</h4>To evaluate the influence of ultrapulsed CO<sub>2</sub> laser in combination with commercial fluoride products in order to verify the increase of microhardness of artificial enamel caries lesions.<h4>Materials and methods</h4>Bovine enamel specimens were prepared, and artificial enamel caries lesions were created. Teeth were randomly divided into 5 groups (n=10): treated with laser (L), laser + neutral fluoride gel 2% (LNF), laser + acidulated phosphate fluoride gel 1.23% (LAFG), laser + acidulated fluoride mousse 1.23% (LAFM), and laser + fluoride varnish 5% (LFV). Microhardness was evaluated at baseline, after caries induction, after CO<sub>2</sub> laser irradiation + fluoride treatment in the 1st week, and after fluoride treatment at 3rd and 5th week.<h4>Results</h4>There was a decrease in microhardness in all groups after artificial enamel caries lesion formation; no increase in microhardness was found in the first and third weeks in all groups (p > 0.05). In the fifth week, an increase in microhardness occurred in all groups (p < 0.05).<h4>Conclusion</h4>Although CO2 laser irradiation in combination with different commercial fluoride products was capable of increasing microhardness on enamel caries lesions in bovine tooth enamel it is necessary to confirm these results by testing the isolated effect of fluoride on enamel surface microhardness. Also, although microhardness was higher in the fluoride varnish group than in the other groups in the fifth week it is not possible to discard the best effect of fluoride varnish treatment on absence of artifacts that may occur with the other fluoride treatments.<h4>Clinical relevance</h4>In order to prove that CO2 laser may contribute to an increase in microhardness when applied to enamel lesions in combination with different commercial fluoride products it is necessary to conduct additional studies. Also, higher microhardness of fluoride varnish group should be carefully considered.
| S-EPMC6106794 | BioStudies
Project description:<h4>Introduction</h4>Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children.<h4>Methods</h4>We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children's parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment.<h4>Results</h4>A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish-related adverse events.<h4>Conclusion</h4>Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children.
| S-EPMC5313125 | BioStudies
Project description:The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core.The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old. We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial.This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).
| S-EPMC4683783 | BioStudies