Adherence to the CONSORT statement of randomized clinical trials on ART restorations in children: current status and reporting characteristics

Wambier, Letícia Maria; Gonçalves, Angela da Ros; Wambier, Denise Stadler; Reis, Alessandra; Chibinski, Ana Cláudia Rodrigues

doi:10.1590/1807-3107bor-2022.vol36.0017

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Systematic Review, Pediatric Dentistry • Braz. oral. res. 36 • 2022 • https://doi.org/10.1590/1807-3107bor-2022.vol36.0017 linkcopy

Adherence to the CONSORT statement of randomized clinical trials on ART restorations in children: current status and reporting characteristics

Authorship SCIMAGO INSTITUTIONS RANKINGS

Appropriate research reports are important to facilitate the evaluation of studies and the decision-making by dentists and policymakers. This meta-research study assessed the conformity of randomized clinical trials (RCTs) on atraumatic restorative treatment (ART) restorations with the CONSORT recommendations and their risk of bias (RoB). Cochrane Library, MEDLINE, BBO, LILACS, Scopus, and Web of Science databases were searched from April 2019 to June 2021 for RCTs that assessed the longevity of ART restorations in children. A specific tool was used to assess adherence to the CONSORT recommendations; RoB was evaluated with the Cochrane risk-of-bias tool. Descriptive analyses included the number of studies by journal, follow-up period, country, and quality assessments. A total of 2,181 papers were retrieved and 36 of them were analyzed qualitatively. The overall CONSORT mean score (CONms) was 22.52 ± 6.17 out of 32 points. The best described items were intervention and outcomes, whereas allocation concealment was described in only 22% of the papers. Significant differences in CONms were detected in the analysis by country and publication dates. High CONms were observed in recently published papers (26.7 ± 3.1) when compared to first ART studies (18.1 ± 4.6; p < 0.001). RoB was low in four studies, unclear in 11, and high in 21. Adherence of the papers to the CONSORT recommendations was not fully achieved and most of the papers had unclear and high RoB (PROSPERO registration #CRD42020201460).

Keywords:
Dental Atraumatic Restorative Treatment; Systematic Review; Randomized Controlled Trial

CONSORT item	Sub item	Score	Adherence of methods and results items to the CONSORT statement
CONSORT item	Sub item	Score	Description
Study design		Positive [2]	The drawing of the essay is clearly written in the text (split mouth, parallel, factorial, cluster).
		Negative [0]	This information is not reported.
		Poor [1]	1. Information can be obtained during the reading of the manuscript, although this is not explicitly reported by the authors.
		Poor [1]	2. There is a lack of consistency between the sections of the article (examples - the abstract does not correspond to the material and methods section; the presentation of the results does not correspond to the description of the study design; the flowchart presents different information, etc.).
Participants	Eligibility criteria	Positive [2]	The inclusion and exclusion criteria are clear, so readers can know exactly know which population the data can be extrapolated to.
		Negative [0]	This information is not reported.
		Poor [1]	1. Incomplete information oneligibility criteria compared to most field studies.
		Poor [1]	2. Presence of inconsistencies in the inclusion/exclusion criteria that prevent readers from knowing the population in which the intervention/control groups were performed.
	Search field and location	Positive [2]	Clear description of the scenario (academic, practice-based research, university, private clinics, etc.), as well as the date on which the intervention was implemented.
		Negative [0]	The setting and/or location are not reported in the text.
		Poor [1]	1. The authors describe the scenario or date, but never both.
		Poor [1]	2. This information can be obtained indirectly in the text.
Interventions		Positive [2]	The interventions for each group are described in sufficient detail to allow replication, including how they were actually administered.
		Negative [0]	No description.
		Poor [1]	Missing information that prevents replication of interventions/comparators.
Outcomes		Positive [2]	At least the primary results were defined in detail, including how and when they were evaluated. Consider this to be clear when the details are clear, but the authors did not use the term “primary result” or related synonyms.
		Negative [0]	There is no definition of primary outcome and/or secondary outcomes.
		Poor [1]	The authors only report having used specific criteria without providing details about the most important results of these criteria.
Sample Size		Positive [2]	The sample size calculation method is described, allowing replication. The primary result for each calculated sample size should be identified. The elements of sample size calculation are (1) the estimated results in each group (implying the clinically important target difference between the intervention groups); (2) the error level α (type I); (3) statistical power (or β error level (type II)); and (4), for continuous results, the standard deviation of the measurements should be reported. For equivalence runs, the equivalence limit instead of the size of the effect size should be reported.
		Negative [0]	There is no description in the article.
		Poor [1]	The sample size is described, but some parameters are missing, avoiding replication.
Randomization	Sequence generation	Positive [2]	1. Clear description of random sequence generation.
		Positive [2]	2. Or clear description of a non-random sequence method.
		Negative [0]	There is no information in the text.
		Poor [1]	The authors only provide a very superficial description (such as the “groups were randomly allocated”) or do not provide enough information to allow replication of the randomization process.
	Allocation concealment	Positive [2]	Clear description of allocation concealment. See the next columns for risk of bias assessment.
		Negative [0]	There is no information in the text.
		Poor [1]	Not applicable.
Blinding		Positive [2]	1) The authors describe who is blinded to the study.2. In blinded studies (when this is clearly reported by the authors), the description of the participant or evaluator (the blinded one) is sufficient; However, when the study is double-blind or triple-blind, all blinded people should be described. 2) The study describes only the participant or blinded examiner, but one of these people cannot be blinded by resources intrinsic to the study design.
		Negative [0]	There is no description of blinding.
		Poor [1]	Poor/partial information. For example, (1) the authors describe the blinding of examiners or the blinding of participants, but never both. (2) The authors describe the study as blind or double-blind, but do not specify who was blinded.
Statistical methods	Hypothesis testing	Positive [2]	Statistical methods are described in sufficient detail, allowing a knowledgeable reader to have access to the original data and verify the reported results. In addition, the statistical tests employed by the authors seem to be appropriate for the type of study and the nature of the data collected.
		Negative [0]	Statistical methods are not described.
		Poor [1]	There is insufficient information to evaluate the statistical method used by the author and/or the type of statistical tests employed by the authors are inappropriate for the design and/or nature of the data (e.g., tests that do not take into account the paired nature of the data when this is the case). 2) The authors describe several statistical tests, but do not specify to which outcome they were applied.
	Effect size estimation	Positive [2]	The authors report, at least for the primary result, the size of the effect and its accuracy (as a 95% confidence interval). Odds ratio, risk ratio, risk difference, mean difference, etc.
		Negative [0]	No description of effect size and confidence interval.
		Poor [1]	Incomplete information.
Flow of participants	Flowchart	Positive [2]	For each group, the number of participants who were randomly assigned, received the desired treatment, and were analyzed for the primary result is described in the flowchart.
		Negative [0]	The flowchart is not presented in the article.
		Poor [1]	1.There are inconsistencies between the numbers described in the flowchart and other parts of the manuscript.
		Poor [1]	2. Incomplete diagram with missing information.
	Losses/Exclusions	Positive [2]	1. For each group, losses and exclusions after randomization and their reasons are described.
		Positive [2]	2.During the reading, the reviewer notes that there are no losses in the follow-up period.
		Negative [0]	No description of losses or exclusions.
		Poor [1]	Incomplete information. For example, 1. The authors describe the overall percentage of losses, but this information is not specified by group. 2. The authors describe the losses and exclusions, but do not specify the reasons.
Baseline data		Positive [2]	A description of the table/text containing the demographic and clinical characteristics of the baseline of each group is presented in the article.
		Negative [0]	There is no table/text description with baseline or description data in the body of the text.
		Poor [1]	1. A table/description of text with baseline data is displayed, but the data are not distributed between the study groups and/or data as percentages instead of raw numbers.
			2. Poor information about the participants.
			3. Inconsistencies may be observed in the data.
Numbers analyzed		Positive [2]	For each group and for each result, the number or participants (denominator) included in the analysis is clear.
		Negative [0]	The authors do not report the numbers analyzed.
		Poor [1]	1. There is no clear description of the number of participants (denominator) included in the analysis of at least one of the results.
			2. Instead of reporting the raw number of participants, the authors report their data as percentages.
			3. The authors do not report the baseline number of patients included in each analysis.
			4. Data can be obtained indirectly in the study.
Registration and Protocol		Positive [2]	The study was recorded in a test record and the protocol number is provided.
		Negative [0]	This information is not available in the manuscript. Registration with the Ethics Committee is not valid as a study record.
		Poor [1]	The authors describe that the study was registered, but did not provide the registration number and/or the registration number is not linked to the study.

Category		Number of studies	Percentage
Journal
	Clinical Oral Investigation	6	16.7
	Caries Research	4	11.1
	Int. Journal of Paedriatric Dentistry	4	11.1
	Community Dent. Oral Epidemiol.	3	8.3
	Other*	19	52.8
Countries
	Brazil	15	41.7
	China	5	13.9
	Netherlands	3	8.3
	Turkey	3	8.3
	Other **	10	27.8
Time period
	1999 - 2004	12	33.3
	2005 – 2009	4	11.1
	2010 – 2014	6	16.7
	2015 - 2021	14	38.9
Follow-up time (year)
0 to 12 months	12	33.3
	13 to 24 months	11	30.6
	25 to 36 months	8	22.2
	37 to 48 months	3	8.3
	more than 48 months	2	5.6

Identification of articles (author, date)	Country of the first author	Protocol registration	Journals (Impact Factor-ISI 2020)	Study design	Restorative materials / (test group - ART x control)	Number of research subjects/ number of teeth	Type of tooth	Classification of cavities	CONSORT included in the Journal guidelines/CONSORT Score
Akman, Tosun 2020⁵³	Turkey	n.r.	Nigerian Journal Clinical Practice (0.42)	Parallel	Composite resin (Filltec Z350) x Bulkfill resin (Sonic fill) x GIC (Equia Fill) x composite resin (X-tra fill)	30 / 160	Deciduous molars	Class II	YES/20
Araújo et al. 2020⁵⁴	Brazil	Yes	BMC Oral Health (0.86)	Parallel	GIC (GIC EQUIA Forte) x Preformed metal crowns (3M/ESPE) cemented with encapsulated GIC (Fuji I)	131 / 131	Deciduous molars	Class II	YES/30 CONSORT extension for abstracts
Arrow, Forrest 2016³⁷	Australia	Yes	Caries Research (2,32)	Parallel	GIC X composite resin, steel crown	220 / 597	Deciduous molars	Class I, II	YES/28
Bonifácio et al. 2013⁵⁵	Netherlands	n.r.	International Journal of Paediatric Dentistry (2,05)	Parallel	Maxxion R (FGM, Rio de Janeiro, Brazil), Hi-Dense (Shofu, Ratingen, Germany), or Fuji IX (GC Europe, Leuven, Belgium)	262/262	Deciduous molars	class II	YES/20
Cefaly et al. 2013⁵⁶	Brazil	n.r.	Brazilian Dental Science (0,2)	Parallel	GIC (Ketac Molar-3M ESPE) X (Fuji VIII-GC Corp).	n.r / 60	Permanent molars	class I and class II	NO/20
Amorim et al. 2014⁵⁷	Brazil	Yes	Clinical Oral Investigations (-2,45)	Parallel	GIC (Ketac Molar Easymix^®; 3M ESPE) X Amalgam (Permite Regular set^®; SDI)	258 / 750	Deciduous molars	class I and class II	YES/32
D’Costa, Singhal, Acharya 2020⁵⁷	India	n.r.	The Journal of Clinical Pediatric Dentistry (0.94)	Parallel	GIC (GC Gold Label 9) x GC Miracle Mix^® (Metal-Reinforced Crown & Core Build-Up)	89/92	Permanent molars or premolars	class I and class II
Lopes et al. 2018³⁸	Brazil	Yes	Pediatric Dentistry (2,05)	Multiple restorations per patient	Equia Fil, GC Europe, Leuven, Belgium X GCP Glass Fill, GCP-Dental, Ridderkerk, Netherlands)	children 33 / teeth 59	Deciduous molars	class II	YES/32
Serpa et al. 2017⁵⁸	Brazil	n.r.	Journal of the Indian Society of Pedodontics and Preventive Dentistry (0,53)	split mouth	Ketac Molar Easy Mix – 3M ESPE X Filtek Z250 – 3M ESPE	children 86/ cavities 216	Deciduous molars	occlusal and occlusa	YES/24
Ersin et al. 2006⁵⁹	Turkey		Journal of American Dental Association (2.49)	split mouth	GIC (Fuji IX GP) x packable resin-based composite (SureFil)	Children 219/cavities 419	Deciduous molars	Class I and II	YES/17
Faustino-Silva, Figueiredo 2019⁴³	Brazil	yes	Clin Oral Investigation (2,45)	split mouth	KetacMolar Easymix^® (3MESPE) X VitroMolar^® (DFL)	children 25/ teeth 100	Deciduous molars	class I	YES/25
Freitas et al. 2018⁴⁴	Brazil	Yes	Journal of Applied Oral Science (1,5)	split mouth	GIC (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia) X encapsulated GIC (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia)	children 40 / teeth 80	Permanent molars	class I	YES/27
Frencken, van’t Hof, Taifour 2007⁶⁰	Netherlands	n.r.	Community Dentistry and Oral Epidemiology (2,27)	Parallel	Avalloy^® (Cavex, Haarlem, The Netherlands) X Fuji IX^® (GC Europe, Leuven, Belgium) and Ketac Molar^® (3MESPE, Seefeld, Germany)	children 681/ restorations 1,117	Permanent molars	class I e class II	YES/22
Gao et al. 2003⁶¹	China	n.r.	Quintessence International (1,39)	Multiple restorations per patient	Fuji IX GP (GC) X Ketac-Molar (3M Dental) X encapsulated amalgam (Central Iron and Steel Research Institute)	adults 68 / teeth 149	Permanent molars	class I	YES/16
Gurunathan, Tandon 2010⁸⁰	India	n.r.	International Journal of Paediatric Dentistry (-2,05)	split mouth	Amalgomer (CR Advanced Health Care) X Fuji IX (GC Corporation Tokyo)	children 100/ teeth 200	Deciduous molars	class I and class II	YES/23
Hilgert et al. 2016⁸¹	Brazil	Yes	International Journal of Paediatric Dentistry (-2,05)	Parallel	Amalgam(Permite (SDI) X Ketac Molar Easymix (3M ESPE)	children n.r / teeth 681	Deciduous molars	class I and class II	YES/28
Ho et al. 1999⁴⁵	China (Hong-Kong)	n.r.	Community Dentistry and Oral Epidemiology (2,27)	Multiple restorations per patient	Fuji IX (GC Int. Corp) X ChemFil Superior (DeTrey/Dentsply)	adults 23 / teeth 100	Permanent molars	class I	YES/12
Honkala et al. 2003⁴⁶	Kuwait	n.r.	International Journal of Paediatric Dentistry (2,05)	split mouth	Chem-Flex (Dentsply/DeTrey) X Megalloy (Dentsply/DeTrey)	children 35 / teeth 70	Deciduous molars	class I, class II	YES/17
Kalf-Scholte et al. 2003⁸²	Netherlands	n.r.	Journal of Public Health Dentistry (1,35)	split mouth	Chelon Silver (ESPE) x Chelon Fil (ESPE a) + amalgam powder (Cavex)	children 83/ teeth 178	Permanent molars	class I	YES/17
Kemoli et al. 2014⁴⁷	Kenya	n..r.	Contemporary Clinical Dentistry (0,69)	Multiple restorations per patient	Fuji IX (GC Europe) x Ketac Molar Easymix (3M ESPE) x Ketac Molar Applicap (3M ESPE)	children n.r / teeth 804	Deciduous molars	occlusal I	YES/18
Lo et al. 2001⁴⁸	China	n.r.	Caries Research (2,32)	split mouth	ChemFlex (Dentsply DeTrey) x Fuji IX GP (GC)	children 89 / teeth 202	Deciduous molars and permanent molars	class I and class II	YES/20
Mandari et al. 2003⁸³	Tanzania	n.r.	Caries Research (2,32)	split mouth	non-gamma-2 amalgam (ANA 200, Nordiska Dental Ab) x Fuji II (GC International Corp.)	children 114 / teeth 341	Permanent molars	class I	YES/25
Menezes, Rosenblat, Medeiros 2006³⁹	Brazil	n.r.	Journal of Dentistry for Children (0,3)	Multiple restorations per patient	Vidrion R GIC (SS White) x Ketac-Molar GIC (3M ESPE)	children 110 / teeth 245	Deciduous molars	class I and class II	YES/24
Menezes-Silva et al. 2019⁸⁴	Brazil	Yes	Clinical Oral Investigations (2,45)	Parallel	Equia system (GC Co.) X Filtek Z350 XT (3M ESPE)	children 154 / teeth 154	Permanent molars	class II	YES/30
Mickenautsch, Yengopal, Banerjee 2000⁸	South Africa	n.r.	Journal of the South African Dental Association (0,19)	Multiple restorations per patient	Fuji IX (GC) X Ketac Molar (ESPE)	113 / 163	Permanent molars	class I	NO/15
Mijan et al.2014⁶³	Netherlands/Brazil	correction of 2014 results data / Yes	Clinical Oral Investigations/ Clinical Oral Investigations(2,45)	Parallel	amalgam (Permite Regular Set^®; SDI) x GIC (Ketac Molar EasyMix^®, 3M ESPE) x ultraconservative treatment (nonrestorative approach)	302 / 866	Deciduous molars	class I and class II	YES/29
Moura et al. 2019⁴⁰	Brazil	Yes	Brazilian Oral Research (1,77)	Multiple restorations per patient	GIC (Ketac Molar, 3N ESPE) x GIC (Vitro Molar, DFL)	243 / 728	Deciduous molars	class I, class II and class III	YES/30
Olegario et al. 2019⁸⁵	Brazil	Yes	Clinical Oral Investigations (2,45)	Parallel “3-arm”	GIC (Equia Fil, GC Europe) x compomer (Dyract Extra, Dentsply International) x glass carbomer (Glass Carbomer Cement, GCP)	578 / 568	Deciduous molars	class I and class II	YES/30
Olegário et al. 2020⁴¹	Brazil	Yes	Journal of Dentistry (3,24)	Parallel “3-arm”	GIC (Fuji IX Gold Label, GC Corp) x GIC (Vitro Molar, nova DFL) x GIC (Maxxion R,FGM)	150 /150	Deciduous molars	Class I	YES/31
Pacheco et al. 2017⁶⁷	Brazil	Yes	Brazilian Oral Research (1,77)	Parallel	Ketac Molar EasyMix (3M ESPE) X Vitro Molar (DFL)	117 / 117	Deciduous molars	class II	YES/28
Taifour et al. 2002⁶⁵	Syria	n.r.	Caries Research (2,32)	Parallel	Fuji IX (GC Europe, Leuven) and Ketac Molar (3MESPE, Seefeld) X Avalloy^® (Cavex)	children 835 / teeth 1891	Deciduous molars	class I and class II	YES/18
Taifour et al. 2003⁶⁴	Syria	n.r.	Community Dent Oral Epidemiol (2,27)	Parallel	Fuji IX (GC Europe, Leuven) and Ketac Molar (3MESPE, Seefeld) X Avalloy^® (Cavex)	children 679 / teeth 1118	Permanent molars	class I and class II	YES/18
Topaloglu et al. 2009⁴⁹	Turkey	n.r.	Clinical Oral Investigations (1,45)	Parallel	Filtek Z250 (3MESPE) X Filtek Z250 (3MESPE) + Carisolv™ (Mediteam)	children 327 / teeth 568	Deciduous molars	class II	YES/21
Yip et al. 2002⁵⁰	China	n.r.	Journal of the American Dental Association (2,49)	Multiple restorations per patient	Fuji IX GP (GC) x Ketac-Molar Aplicap (3M ESPE) x encapsulated GK Amalgam Alloy (Advanced Technology & Materials Co. Ltd. Beijing)	adults 68/ teeth 149	Permanent molars	class I	YES/12
Yu et al. 2004⁵¹	China	n.r.	International Dental Journal (1,62)	Multiple restorations per patient	Fuji IX GP (GC) x Ketac Molar Aplicap (3M ESPE) x Encapsulated non-gamma 2 GK amalgam alloy (Central Iron & Steel Institute)	children 60/ teeth 167	Deciduous molars	class I and class II	YES/16
Ziraps, Honkala 2002⁵²	Kuwait	n.r.	Medical Principles and Practice (1,53)	n.r	Chem Flex TX (Dentsply) X Fuji IX (GC)	children 41 / teeth 63	Permanent molars	class I	YES/13

Category		Mean ± Standard Deviation	Median	p-value*
Category		Mean ± Standard Deviation	(interquartile range)	p-value*
Journal
	Clinical Oral Investigations	27.5 ± 3.4	27.5 (23-28)
	Caries Research	22.5 ± 3.9	22.5 (19-25.5)
	Int. Journal of Paediatric Dentistry	21.5 ± 3.9	21.5 (18.5-24.5)	p = 0.218
	Community Dent. Oral Epidemiol.	18 ± 5	18 (13.5-21)
	Other*	24 ± 5.9	24 (17.3-26)
Country
	Brazil	26.8 ± 3.2ᵃ	27 (24.3-30)
	China	16.4 ± 4.5^b	16 (12-20.5)
	Netherlands	21.6 ± 4.5ᵃ,^b	22 (18.3-25)	p < 0.001
	Turkey	19.3 ± 2.08^b	20 (17.8-20.8)
	Other **	20.8 ± 4.5 ^c,b	20.5 (18-25)
Publication date
	1999 – 2004	18.1 ± 4.6 ^b	17.5 (14.5-22)
	2005 – 2009	22.7 ± 1.5 ^a,b	23 (21.5-24)	p < 0.001
	2010 – 2014	23.0 ± 4.6 ^a,b	21.5 (20-27.0)
	2015– 2020	26.7 ± 3.1ᵃ	26 (25-30)
Follow-up period (year)
	0 to 12 months	24.3 ± 4.8	24 (23.5 – 27)
	13 to 24 months	20.0 ± 6.4	18 (16.3 – 24.8)
	25 to 36 months	21.1 ± 4.7	20 (18.0 – 22.5)	p = 0.274
	37 to 48 months	25.3 ± 2.1	26 (23.7 -26.7)
	more than 48 months	23.5 ± 2.1	23.5 (22 – 25.0)

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Other: 16 journals (BMC Oral Health; Brazilian Dental Science, Pediatric Dentistry, Journal of the Indian Society of Pedodontics and Preventive Dentistry, Journal of Applied Oral Science, Journal of Public Health Dentistry, Contemporary Clinical Dentistry, Journal of Dentistry for Children, Journal of the South African Dental Association, Brazilian Oral Research, Journal the American Dental Association, International Dental Journal, Medical Principles and Practice, Nigerian Journal of Clinical Practice, Journal of Clinical Paediatric Dentistry, Quintessence International, and Journal of Dentistry)

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Other: 7 countries (Kenya, Tanzania, South Africa, Australia, Kuwait, India, and Syria)