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Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial.

ABSTRACT: The aim of the present study was to assess pain and the need for anesthesia during chemomechanical caries removal with Papacarie gel and the traditional method (low-speed bur) in pediatric patients. A randomized, controlled, clinical trial with a "split-mouth" design was carried out involving 20 children (10 girls and 10 boys) aged four to seven years. Forty primary teeth (two per child) were randomly allocated to either Group 1 (G1: chemomechanical caries removal with Papacarie gel) or Group 2 (G2: removal of carious dentin with low-speed bur). A face scale was used to classify the sensation of pain during the procedure (1: absence of pain; 2: mild pain; 3: moderate pain; 4: moderately intense pain; 5: intense pain; and 6: extremely intense pain). Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney (U) test. Pain scores were higher in G2, with statistically significant differences in comparison to G1 (U = 148.0; W = 358.0; P = 0.041). Chemomechanical caries removal with Papacarie provides a lesser degree of pain in comparison to conventional caries removal and does not require the use of local anesthesia. The clinical trial registration number is NCT01811420.

SUBMITTER: Motta LJ

PROVIDER: S-EPMC3865729 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial.

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

International journal of dentistry 20131204

The aim of the present study was to assess pain and the need for anesthesia during chemomechanical caries removal with Papacarie gel and the traditional method (low-speed bur) in pediatric patients. A randomized, controlled, clinical trial with a "split-mouth" design was carried out involving 20 children (10 girls and 10 boys) aged four to seven years. Forty primary teeth (two per child) were randomly allocated to either Group 1 (G1: chemomechanical caries removal with Papacarie gel) or Group 2 ...[more]

PMID: 24363672

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Project description:ObjectivesFor well-defined deep (>?2/3 dentin extension) carious lesions, selective (SE) or stepwise (SW) carious tissue removals have been recommended, while there is limited comparative evidence for both. We compared SE and SW over 24 months in a randomized controlled trial.MethodsA two-arm superiority trial was conducted comparing SW/SE in primary molars without pulpal symptoms but well-defined deep lesions. Seventy-four children (1 molar/child) aged 3-9 years were recruited. In a first step, peripheral carious tissue was removed until hard dentin remained, while in proximity to the pulp, leathery dentin was left. An adhesive compomer restoration was placed and restorations re-examined after 6 months. In SW, re-entry and removal to firm dentin was conducted pulpo-proximally, followed by re-restoration. Molars were re-evaluated for a total of 24 months. Our primary outcome was success (absence of restorative/endodontic complications or pulp exposures). Secondary outcomes included total treatment and opportunity costs and restoration quality, assessed using modified USPHS criteria.ResultsAfter 24 months, 63 molars (31 SE, 32 SW) were re-assessed. Four failures occurred (2 exposures in SW; 2 pulpal complications in SE, 1 of them leading to extraction, p?>?0.05). Restoration integrity was satisfying in both groups (USPHS A/B/C in 21/8/0 SE and 23/7/0 SW, p?>?0.05). Treatment and opportunity costs were significantly higher in SW than SE (mean 171?±?51 vs. 106?±?90; p?<?0.001).ConclusionsAfter 2 years, SE and SW showed similar efficacy for managing deep carious lesions in primary molars. The higher costs for SW should be considered during decision-making.Clinical significanceIn primary molars with well-defined deep carious lesions SE was less costly and similarly efficacious like SW. From a cost and applicability perspective, SW may need to be indicated restrictively, e.g., for very deep (>?3/4 dentin extension) lesions only.Trial registrationClinicalTrials.gov Identifier: NCT02232828.

Project description:BackgroundDental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth.MethodThis is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes.DiscussionSCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN.Trial registration numberISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Project description:ObjectivesTo compare the success, survival and costs of selective versus stepwise carious tissue removal (SE/SW) in permanent teeth with deep (>2/3 dentine depth) carious lesions.DesignRandomised controlled, unicentre, clustered two-arm superiority trial.SettingOutpatient clinic of a private university in Cairo, Egypt.ParticipantsOne hundred and fifteen participants (n=132 teeth), aged 18-47 years, from Cairo, Egypt, were enrolled. Premolars/molars with occlusal/occlusal-proximal deep lesions (radiographically >2/3 dentine), sensible pulps, without spontaneous pain, were included.InterventionsPeripheral carious tissue removal to hard dentine was performed. Pulpo-proximally, soft dentine was left. A glass ionomer (GI) restoration was placed. After 3-4 months, teeth were randomly allocated to SE (n=66), with reduction of the GI into a base and no further tissue removal, followed by a composite resin restoration, or SW (n=66), with full removal of the GI, additional excavation until firm dentine pulpo-proximally, followed by a GI-based composite restoration. Mean follow-up was 1 year.Primary and secondary outcome measuresPrimary outcome was success (absence of endodontic/restorative complications). Secondary outcomes were tooth survival and initial and total treatment costs.ResultsZero/five pulp exposures occurred during SE/SW, and seven/five SE/SW teeth required endodontic therapy. Success after 12 months was 89.4% for SE and 84.9% for SW. The estimated mean time free of complications was 23 and 18 months for SE and SW, respectively, without significant differences between SE and SW (p>0.05/Cox). Initial treatment costs were significantly higher for SW (mean (SD): 507.5 (123.4) Egyptian pounds (EGP)) than SE (mean (SD): 456.6 (98.3) EGP), while total costs showed no significant difference (p>0.05).ConclusionWithin the limitations of this interim analysis, and considering the depth of these lesions (>2/3 dentine), SE and SW showed similar risk of failure and overall costs after 1 year.Trial registration numberPACTR201603001396248.

Project description:BackgroundThe lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry.MethodsOverall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C?+?P), biological management of carious lesions and prevention (B?+?P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis.ResultsParticipants discussed perceived effectiveness of, and familiarity with, the three techniques. The C?+?P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B?+?P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children.ConclusionsRCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.

Project description:To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device.This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ?3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized.A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events.The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

Dataset Information

Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial.

Publications

Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial.

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