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"Administration, Topical"
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Effect of intensive application of self-assembling peptide P11-4 with fluoride, casein phosphopeptide amorphous calcium phosphate fluoride and sodium fluoride on streptococcus mutans level in preschool children: a randomized controlled clinical trial
by
Khairy, Sarah M.
,
Essa, Sara A. M.
,
Talaat, Dalia M.
in
Antibacterial activity
,
Calcium phosphates
,
Cariostatic Agents - pharmacology
2025
Objectives
To compare the effect of self-assembling peptide P11-4 with fluoride, casein phosphopeptide amorphous calcium phosphate fluoride (CPP-ACPF) varnish and 5% sodium fluoride varnish (NaF), on Streptococcus mutans (S. mutans) in dental plaque of preschoolers in addition to assessing change in plaque index after their intensive application.
Methods
Sixty-six preschoolers were randomly assigned into three groups to receive triple applications of P11-4 with fluoride, CPP-ACPF varnish or NaF. S. mutans count in supragingival plaque samples was assessed at baseline (T0) and after the third application by 48 h (T1), one month (T2) and 3 months (T3). Multivariable linear regression compared the effect of these materials on S. mutans log count at various time intervals. Baseline plaque index was compared to that at T2 and T3.
Results
All study groups presented a significant decrease in S. mutans count at T1, T2 and T3. Multivariable linear regression demonstrated a significant more reduction in S. mutans count in CPP-ACPF and NaF groups when compared to P11-4 with fluoride at T1. At T2 and T3, CPP-ACPF showed superior reduction in bacterial count than NaF and P11-4 with fluoride, with no significant difference between the latter two materials. Plaque index was significantly reduced at all study groups at T2 and T3, with CPP-ACPF being the most proficient.
Conclusion
CPP-ACPF presented superior antibacterial effect when compared to P11-4 with fluoride or NaF which exhibited comparable antibacterial effect.
Clinical relevance
Different remineralizing agents can have additive antibacterial effect against S. mutans that affects individual’s future caries experience.
Journal Article
Efficacy of Silver Diamine Fluoride for Arresting Caries Treatment
by
HOLMGREN C.
,
YEE R.
,
WALKER D.
in
arresting caries treatment
,
Cariostatic Agents - administration & dosage
,
Cariostatic Agents - therapeutic use
2009
Arresting Caries Treatment (ACT) has been proposed to manage untreated dental caries in children. This prospective randomized clinical trial investigated the caries-arresting effectiveness of a single spot application of: (1) 38% silver diamine fluoride (SDF) with tannic acid as a reducing agent; (2) 38% SDF alone; (3) 12% SDF alone; and (4) no SDF application in primary teeth of 976 Nepalese schoolchildren. The a priori null hypothesis was that the different treatments have no effect in arresting active cavitated caries. Only the single application of 38% SDF with or without tannic acid was effective in arresting caries after 6 months (4.5 and 4.2 mean number of arrested surfaces; p < 0.001), after 1 year (4.1 and 3.4; p < 0.001), and after 2 years (2.2 and 2.1; p < 0.01). Tannic acid conferred no additional benefit. ACT with 38% SDF provides an alternative when restorative treatment for primary teeth is not an option.
Journal Article
Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets
2020
Enamel demineralisation can occur as a side effect during orthodontic treatment with fixed appliances. This study aimed to evaluate the efficacy of the self-assembling peptide P
11
-4 for remineralisation combined with fluorides, compared to application of fluoride varnish alone. De- and remineralisation was assessed by Quantitative light-induced fluorescence (QLF). Orthodontic brackets were bonded on 108 human enamel samples and white spot lesions were created. The samples were allocated randomly into three groups: Group I received no treatment, group II had a single application of fluoride varnish (22,600 ppm), and group III was treated with P
11
-4 following a single application of fluoride varnish. Quantitative light-induced fluorescence (QLF) measurements were performed at baseline, after demineralisation and after storage in remineralisation solution for 7 and 30 days. Non-parametric tests (Kruskal–Wallis test and Friedman test) were used for further analysis. After demineralisation, all samples showed a median ΔF -9.38% ± 2.79. After 30 days median ΔF values were as followed: group I = -9.04% ± 2.51, group II = -7.89 ± 2.07, group III = -6.08% ± 2.79). The median ΔF values differed significantly between all groups at all investigation times (p < 0.00001). Application of P
11
-4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.
Journal Article
Effect of the casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) and photobiomodulation (PBM) on dental hypersensitivity: A randomized controlled clinical trial
by
Alencar, Cristiane de Melo
,
Alves, Eliane Bemerguy
,
Silva, Cecy Martins
in
Adolescent
,
Adult
,
Biology and Life Sciences
2019
This randomized controlled clinical trial aimed to evaluate the effect of the casein phosphopeptide-amorphous calcium phosphate fluoride (CPP-ACPF) and photobiomodulation (PBM) in the treatment of dentin hypersensitivity (DH), and the impact of this on the health-related quality of life (HRQL).
Eighty teeth with DH were randomized into four groups and received three treatment sessions: PLACEBO = placebo + LASER application mimicking; CPP-ACPF = CPP-ACPF + LASER application mimicking; PBM = placebo + LASER active application; CPP-ACPF+PBM = CPP-ACPF + LASER active application. Tactile (exploratory probe) and evaporative (triple syringe) stimuli were used to measure DH and were recorded with the aid of a visual analogue scale (VAS) after the 1st, 2nd and 3rd treatment sessions and one-month follow-up. The HRQL was recorded in the DH experience questionnaire (DHEQ).
The intragroup comparison showed a significant reduction in DH (p < 0.05) with both stimuli after one-month follow-up. The intergroup comparison with the evaporative stimulus showed that CPP-ACPF+PBM significantly reduced DH when compared to the rest of treatments, after one-month follow-up. CPP-ACPF+PBM group statistically differed from the other treatment groups in the DHEQ evaluation after one-month follow-up.
After one-month follow-up, the association of CPP-ACPF with PBM was effective in the reduction of DH and promoted a positive impact on the HRQL of the participants of this study.
Journal Article
Topical Administration of Terpenes Encapsulated in Nanostructured Lipid-Based Systems
Terpenes are a group of phytocompounds that have been used in medicine for decades owing to their significant role in human health. So far, they have been examined for therapeutic purposes as antibacterial, anti-inflammatory, antitumoral agents, and the clinical potential of this class of compounds has been increasing continuously as a source of pharmacologically interesting agents also in relation to topical administration. Major difficulties in achieving sustained delivery of terpenes to the skin are connected with their low solubility and stability, as well as poor cell penetration. In order to overcome these disadvantages, new delivery technologies based on nanostructures are proposed to improve bioavailability and allow controlled release. This review highlights the potential properties of terpenes loaded in several types of lipid-based nanocarriers (liposomes, solid lipid nanoparticles, and nanostructured lipid carriers) used to overcome free terpenes’ form limitations and potentiate their therapeutic properties for topical administration.
Journal Article
Effects of silver diamine fluoride on oral bacteriome and mycobiome: a randomized clinical trial
by
Singh, Sarbjeet
,
Chelikani, Prashen
,
Manerkar, Mayura
in
Bacteria
,
Care and treatment
,
Cariostatic Agents - administration & dosage
2025
Background
Silver diamine fluoride (SDF) is a simple and non-invasive agent used to arrest early childhood caries (ECC). This study aimed to investigate potential changes to the oral microbiome in children with ECC who were treated with SDF and sodium fluoride (NaF) varnish at three different frequency regimens.
Methods
Forty-five children (
n
= 15 per group) with ECC were recruited from community-based dental clinics in Winnipeg, Canada into an open-label, parallel-group, randomized clinical trial testing three different treatment frequency regimens of SDF. A total of 195 carious lesions were treated with two applications of 38% SDF and 5% NaF varnish (and assessed over three study visits one month, four months, or six months apart. Dental plaque samples were collected at each visit. Sequencing of the V4-16 S rRNA and ITS1 rRNA genes were used to study the supragingival plaque microbiome.
Results
Microbial diversity analyses showed no significant differences in the overall microbiome after SDF treatment. However, significant changes in the abundance of specific bacteria and fungi, particularly
Lactobacillus
spp.,
Bifidobacterium
spp., and
Candida
spp., were observed after treatment. Furthermore, overabundance of
Streptococcus mutans
and
Candida dubliniensis
at baseline was observed in children who had at least one caries lesion not arrested after one SDF application, compared to those who had 100% arrest rates. The overall arrest rates for treated carious lesions were 75.9% at the second visit and 92.8% at the third visit. Arrest rates were higher for all lesions after two applications of SDF with NaF varnish, and applications one month and four months apart had higher arrest rates (95.9% and 98.5%) than six months (81.1%) apart.
Conclusions
Applications of SDF with NaF varnish were an effective modality for arresting ECC, with higher arrest rates after two SDF applications. No loss of diversity but changes in the abundance of specific bacteria and fungi were observed after SDF treatment.
Trial registration
ClinicalTrials.gove NCT04054635 (first registered 13/08/2019).
Journal Article
Effects of various remineralizing agents on the outcome of post-orthodontic white spot lesions (WSLs): a clinical trial
by
Jena, Ashok Kumar
,
Singh, Satinder Pal
,
Goyal, Ashima
in
Adolescent
,
Adult
,
Cariostatic Agents - administration & dosage
2016
Background
One of the most undesirable side effects of comprehensive orthodontic treatment is white spot lesions (WSLs). Despite many attempts at prevention of WSLs, its prevalence remains very high on debonding. There are many agents like fluoride toothpastes, fluoride varnishes, and fluoride mouth rinses, and casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) is frequently used for the remineralization of WSLs. However, there is no consensus in the literature with respect to the success rates of these agents. Thus, the present study was designed to evaluate the efficacy of fluoride toothpaste alone and in combination with fluoride varnish and CPP-ACP plus crème in the remineralization of post-orthodontic WSLs.
Methods
Forty-five subjects in the age range of 16–25 years having at least one post-orthodontic WSL were included in the study. All the subjects were randomly divided into three groups (toothpaste group, varnish group, and CPP-ACP group). The efficacy of various remineralizing agents on the remineralization of WSLs was evaluated clinically and by DIAGNOdent immediately after debonding and subsequently after 1, 3, and 6 months of their use.
Results
Twice daily use of fluoride toothpaste alone had no significant effect on remineralization of WSLs at various intervals of observations (
P
= 0.078). Application of fluoride varnish along with twice daily use of fluoride toothpaste for 6 months significantly decreased the severity of WSLs (
P
< 0.01). Twice daily use of CPP-ACP plus crème along with fluoride toothpaste had significant effect on remineralization of WSLs at the end of 6 months of observation (
P
< 0.05). Between the group comparison showed that the mean visual and DIAGNOdent scores at various time intervals of observations were decreased more when fluoride varnish and CPP-ACP crème were used in addition to daily use of fluoride toothpaste, but the differences were not statistically significant (
P
> 0.05).
Conclusions
The use of fluoride varnish and CPP-ACP plus crème in addition to twice daily use of fluoride toothpaste had no additional benefit in the remineralization of post-orthodontic WSLs.
Journal Article
Nonlinear Pharmacokinetics of Topical Flurbiprofen Gel in a Phase I Study Among Chinese Healthy Adults
2024
IntroductionPDX-02 (Flurbiprofen sodium) is a topical nonsteroidal anti-inflammatory drug in gel formulation for local analgesia and anti-inflammation. A Phase I clinical trial was conducted to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PDX-02 gel in Chinese healthy adults.MethodsThe trial comprised three parts: (1) a single-dose ascending study with three dose levels (0.5%, 1% to 2% PDX-02 gel) applied on a 136 cm2 skin area; (2) a multiple-dose study with either 1% or 2% PDX-02 gel applied on a 136 cm2 skin area for 7 consecutive days; and (3) a high dose group with 2% PDX-02 gel on an 816 cm2 skin area and a frequent multiple dose group with 2% PDX-02 gel on a 272 cm2 skin area four times a day for 7 consecutive days. The safety, tolerability and pharmacokinetics of the PDX-02 gel were evaluated in each part.ResultsA total of sixty participants completed the trial, with all adverse events recovered and all positive skin reaction being transient and recovered. The overall absorption of topical PDX-02 gel was slow with a mean peak time exceeding 9 h. The elimination rate remained consistent between dose groups. A less-than-dose-proportional nonlinear pharmacokinetics relationship was observed within the studied dose range, and this is likely due to the autoinduction of skin first-pass metabolism.ConclusionThe topical PDX-02 gel showed favorable safety and tolerability in both single and multiple dosing studies, with a less-than-dose-proportional nonlinear pharmacokinetics observed.
Journal Article
Application and evaluation of topical amphotericin B for the treatment of respiratory fungal infections
2024
Background
In recent years, the prevalence of respiratory fungal diseases has increased. Polyene antifungal drugs play a pivotal role in the treatment of these conditions, with amphotericin B (AmB) being the most representative drug. This study aimed to evaluate the efficacy and safety of topical administration of AmB in the treatment of respiratory fungal infections.
Methods
We conducted a retrospective study on hospitalized patients treated with topical administered AmB for respiratory fungal infections from January 2014 to June 2023.
Results
Data from 36 patients with invasive pulmonary fungal infections treated with topical administration of AmB were collected and analyzed. Nebulization was administered to 27 patients. After the treatment, 17 patients evidenced improved conditions, whereas 10 patients did not respond and died in the hospital. One patient experienced an irritating cough as an adverse reaction. Seven patients underwent tracheoscopic instillation, and two received intrapleural irrigation; they achieved good clinical therapeutic efficacy without adverse effects.
Conclusion
The combined application of systemic antifungal treatment and topical administration of AmB yielded good therapeutic efficacy and was well-tolerated by the patients. Close monitoring of routine blood tests, liver and kidney function, and levels of electrolytes, troponin, and B-type natriuretic peptide supported this conclusion.
Journal Article
Effectiveness of tranexamic acid in intervening postpartum vaginal lacerations
2025
Aims
This prospective randomized controlled study aimed to investigate the effectiveness of tranexamic acid in controlling bleeding due to postpartum vaginal lacerations and to compare the intravenous (IV) and topical routes of administration. The rationale for exploring topical administration was to identify a more practical and less invasive alternative to IV administration.
Methods
Between January 2024 and November 2024, 161 women aged 20–35 years who had spontaneous vaginal deliveries without episiotomy at Mardin Education and Research Hospital, experienced superficial vaginall acerations, and had postpartum blood loss not exceeding 500 ml were included. All pregnancies were singleton, without fetal anomalies, and the length of labor was documented. Patients were randomly assigned to one of three groups: topical tranexamic acid
(
1g in 10ml salineapplied to the laceration for 10 minutes), IV tranexamic acid (1g infused over 10 minutes), or a control group (no tranexamic acid). Blood loss was assessed using the gravimetric method by measuring the weight difference of blood-soaked pads. Hemoglobin, hematocrit, platelet counts, and INR values were measured before birth and at the3rd postpartum hour.
Results
Blood loss (pad count and total pad weight) was significantly lower in both tranexamic acid groups compared to the control group (p < 0.001). However, there was no significant difference in blood loss between the topical and IV tranexamic acid groups (
p
= 0.288 and
p
= 1.000, respectively). The decrease in hemoglobin was significantly lower in the IV tranexamic acid group compared to the control group (
p
= 0.008), but no significant difference was observed between the topical and IV groups (
p
= 0.113). Hospital stay was significantly shorter in the topical tranexamic acid group compared to the control group (
p
= 0.006), with no difference between the topical and IV groups (
p
= 0.406).
Conclusion
Topical tranexamic acid application resulted in similar reductions in bleeding compared with IV administration, and no statistically significant difference was detected between the two routes in this specific context of limited blood loss (< 500 ml). Given its practical advantages, topical application may be a viable alternative to IV administration. Further research is warranted to confirm these findings in cases of more significant postpartum hemorrhage.
Trial registration
Clinical trial NCT07094399. Registered 29 July 2025. Retrospectively registered, justification for the delay is provided in the methods section.
Journal Article