Dataset Information

Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

ABSTRACT:

Objectives

Compare the effectiveness of Papacarie™ gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings.

Material and methods

A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with Papacarie™ and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations.

Results

No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment.

Conclusion

Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

SUBMITTER: Motta LJ

PROVIDER: S-EPMC4126827 | biostudies-literature | 2014 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

Motta Lara Jansiski LJ Bussadori Sandra Kalil SK Campanelli Ana Paula AP Silva André Luis da AL Alfaya Thays Almeida TA Godoy Camila Haddad Leal de CH Navarro Maria Fidela de Lima MF

Journal of applied oral science : revista FOB 20140701 4

<h4>Objectives</h4>Compare the effectiveness of Papacarie™ gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings.<h4>Material and methods</h4>A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: ...[more]

PMID: 25141203

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Project description:BackgroundFor treating deep caries lesions, selective or stepwise (one- and two-step) incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any retreatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients', dentists' or parents' preferences nor the clinical long-term costs emanating from both initial and retreatments have been reported yet.Methods/designThe planned study is a prospective multicenter, two-arm parallel group, randomized controlled clinical trial comparing selective and stepwise excavation in deciduous molars with deep, active caries lesions without pulpal symptoms. We will recruit 300 children aged between three and nine-years-old with a minimum of one such molar. Patients participating in another study, or those with systemic diseases, disabilities or known allergies to used materials as well patients with teeth expected to exfoliate within the next 18 months will be excluded. After inclusion, sequence generation will be performed. Initial treatment will follow dental routine. During excavation, leathery, moist and reasonably soft dentin will be left in proximity to the pulp followed by adhesive restoration of the cavity. Afterwards, patients', dentists' and parents' subjective assessment of the treatment will be recorded using visual analogue or Likert scales. Re-examination will be performed after six months, and only then teeth will be allocated to one of the two interventions. Selectively excavated teeth will not be treated further, whilst for stepwise caries removal, a second excavation will be performed until only hard dentin remains. Clinical re-evaluations will be performed after 12, 24 and 36 months. Restorations will be reassessed using modified Ryge criteria. Objectively or subjectively required retreatments will determine success and survival. Retreatments will be evaluated both subjectively and regarding generated costs.DiscussionBased on the results of the trial, decision-making for treating deep caries lesions in deciduous molars based on multiple criteria should be feasible.Trial registrationClinicaltrials.gov identifier: NCT02232828 (registered on 29 November 2014).

Project description:Background:Casein-phosphopeptide-amorphous-calcium-fluoride-phosphate (CPP-ACFP) can remineralize subsurface lesions. It is the active ingredient of MI-Paste-Plus® (MPP). The long-term remineralization efficacy is unknown. Objective:To evaluate the long-term effect of MPP versus a placebo paste on remineralization of enamel after fixed orthodontic treatment over a 12-month period. Design:This trial was designed as a prospective, double-blinded, placebo-controlled RCT. Methods:Patients with subsurface lesions scheduled for removal of the appliance were included. They applied either MPP or control paste once a day at bedtime for 12 months, complementary to normal oral hygiene. Main outcome measures:Changes in enamel lesions (primary outcome) were fluorescence loss and lesion area determined by quantitative light-induced fluorescence (QLF). Secondary outcomes were Microbial composition, by conventional plating, and acidogenicity of plaque, by capillary ion analysis (CIA), and lesion changes scored visually on clinical photographs. Randomization:Participants [age = 15.5 years (SD = 1.6)] were randomly assigned to either the MPP or the control group, as determined by a computer-randomization scheme, created and locked before the start of the study. Participants received neutral-coloured concealed toothpaste tubes marked A or B. Blinding:The patients and the observers were blinded with respect to the content of tube A or B. Results:A total of 51 patients were analysed; MPP (n = 25) versus control group (n = 26); data loss (n = 14). There was no significant difference between the groups over time for all the used outcome measures. There was a significant improvement in enamel lesions (fluorescence loss) over time in both groups (P < 0.001 and P < 0.001), with no differences between groups. Limitations:Being an in vivo study, non-compliance of the subjects could have influenced the result. Conclusion:The additional use of MPP in patients with subsurface enamel lesions after orthodontic fixed appliance treatment did not improve these lesions during the 1 year following debonding. Registration:This trial is registered at the medical ethical committee of the VU Medical Centre in Amsterdam (NL.199226.029.07).

Project description:PurposeTo construct an online caries management platform and evaluate its efficacy in children's caries prevention based on caries risk.MethodsThe study participants were second-grade pupils. The caries risk assessment tool (CAT) was used to grade caries risk for all participants, who were randomly divided into the experimental (114 pupils) and control (111 pupils) groups. The experimental group used the Internet for caries management, while the control group was managed by traditional lecturing in classroom. The caries status of each surface of the first permanent molars was recorded. The basic information and oral health knowledge, attitude, and behaviors of participants were collected by questionnaire. One year later, outcome data were collected. Pearson's chi-squared test was used to analyze the caries risk assessment items and oral health behaviors. The Mann-Whitney U-test was used to analyze the decayed-missing-filled surfaces (DMFS) index, plaque index, and scores of oral health knowledge and attitude. P < 0.05 was considered statistically significant. This study was available on the website of Chinese Clinical Trials Register (No: MR-44-22-012947).ResultsAfter 1 year, the oral health knowledge score was improved by 20.58% (P < 0.001) in the experimental group and 6.02% in the control group. The plaque index was improved by 49.60% (P < 0.001) in the experimental group and 21.01% in the control group. The DMFS index increased in both groups but there were no significant differences (P = 0.608). The experimental group had a better improvement effect in caries risk assessment items than the control group, including "whether the frequency of eating sugary snacks or drinks between meals is more than 3 times/day" (P = 0.033) and the use of fluoridated toothpaste (P = 0.020). The experimental group was better than the control group in reported oral health behaviors, including frequency of eating sweets before sleep (P = 0.032), brushing time (P = 0.001), and the filled rate (proportion of FS in DMFS) of first permanent molars (P = 0.003).ConclusionsThe online caries management platform showed more advantages than traditional lecturing in improving oral health knowledge and behaviors (oral hygiene practice, sugar consumption behavior, and medical treatment behavior). This platform provides a reliable implementation path for the occurrence and continuous improvement of oral health-related behaviors.

Project description:ObjectivesThe aim of this randomized clinical trial was to compare selective removal to soft dentin (SRSD) and selective removal to firm dentin (SRFD) in permanent teeth. The primary outcome of the study was to compare the success rates of the two caries removal techniques. The secondary outcome of the study was to investigate whether or not calcium silicate-based material (CS) had an effect on the success rate of the treatment.Materials and methodsBetween November 2018 and March 2020, patients with deep caries lesions were invited to participate in the study. Posterior teeth (N = 165) with primary caries lesion radiographically extending ¾ of dentin and positive response to cold test were randomly selected. A total of 134 participants meeting the inclusion criteria were randomized to SRSD and SRFD (control) groups. After the caries removal procedure, teeth with exposed pulps were assigned to the pulp exposure (PE) group, and the SRSD group was further divided into test 1 (with CS) and test 2 groups (without CS). Success was defined as a positive response to the cold test, a negative response to percussion, the absence of pain, an abscess, a fistula, and periapical alterations. Fisher-Freeman-Halton exact tests, Kaplan-Meier survival analysis, and the log-rank tests were performed for comparisons between groups.ResultsNo statistically significant difference was found between the success rates of test 1 (100%) and test 2 (93.5%) groups, whereas the proportion of success in control (82.4%) and PE (84%) groups were significantly lower when compared with test groups (p = 0.024; p < 0.05) at the end of 2-year follow-up.ConclusionsSRSD had a higher success rate when compared to SRFD to treat deep carious lesions after 2 years of follow-up. The use of CS material after SRSD as a liner had no effect on the treatment outcome.Clinical relevanceSRSD with good coronal sealing might be recommended without CS application for the treatment of deep caries lesions in permanent teeth.Trial registrationClinical trial registration number NCT04052685 (08/09/2019).

Project description:IntroductionThe literature shows that selective carious tissue removal (SCTR) decreases the number and diversity of bacteria, stops the caries process and reduces the risk of pulp exposure. However, no consensus exists on which pulp liner would be suitable for teeth undergoing SCTR. So, this study will verify the in vivo response of dentine-pulp complex after SCTR in primary teeth with or without pulp liner material.Methods and analysisA randomised clinical trial, double-blinded, parallel-group and allocation concealment will be conducted with the enrolment of 384 patients from 5 to 9 years, with one maxillary/mandibular first/second primary molars with deep occlusal/occlusoproximal cavities. The remaining dentine will be lined with calcium hydroxide cement-group 1; mineral trioxide aggregate-group 2 and without liner-group 3. The primary outcome will be success of the of dentine-pulp complex evaluated clinically and radiographically at 6, 12 and 24 months, while the secondary outcomes will be the measurement of the dentine barrier on periapical radiographs. During all study, two trained and calibrated examiners will evaluate the treated teeth clinically and radiographically. Interexaminer and intraexaminer reliability will be verified by casual and systematic error. The Kolmogorov-Smirnov test will be adopted to test the normality of continuous variables. Comparisons among groups will be performed by using the χ2 test and anaylsis of variance, followed by Tukey test (p<0.05). The logistic regression will be applied, and the degrees of this association will be measured using the OR and 95% CI.Ethics and disseminationThe present protocol was submitted and approved by the Ethical Committee of the University of São Paulo, Bauru, São Paulo, Brazil (CAAE: 79123517.0.0000.5417). Consent for publication will be obtained from all parents or legal guardians. Results of this study will be reported in full through peer-reviewed journals.Trial registration numberRBR-9fsxnn.

Dataset Information

Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

Objectives

Material and methods

Results

Conclusion

Publications

Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

Similar Datasets

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