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RESEARCH REPORT |
1 WHO Collaborating Centre for Oral Health Care Planning and Future Scenarios, Radboud University Medical Centre, College of Dental Sciences, PO Box 9101, 6500 HB Nijmegen, the Netherlands;
2 School Health Department, Ministry of Education, Damascus, Syria; and
3 Department of Preventive and Restorative Dentistry, Radboud University Medical Centre, College of Dental Sciences, P.O. Box 9101, 6500 HB Nijmegen, the Netherlands
* corresponding author, j.frencken{at}dent.umcn.nl
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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0.044). After 6.3 years, the cumulative survival percentages of ART and amalgam restorations were 66.1% (SE = 3.1%) and 57.0% (SE = 3.3%), respectively. We concluded that the restorations produced with the ART approach, with high-viscosity glass ionomer, survived longer than those produced with the traditional approach, with amalgam, in the permanent teeth of young children.
KEY WORDS: restorations • atraumatic restorative treatment • amalgam • glass ionomer • survival
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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Because the difficulties encountered by the school health department in implementing the traditional restorative care concept at the schools were caused by its high cost and dependency on electricity, it was decided to look for alternative means of providing restorative care. One of the options considered was the Atraumatic Restorative Treatment (ART) approach. This approach uses only hand instruments in combination with an adhesive restorative material, usually an auto-cured glass ionomer, and can be applied on school premises (Frencken et al., 1996).
However, at the time when the inclusion of the ART approach into the oral health services was discussed (1996), only one study had been published on the effectiveness of the ART approach in comparison with the traditional approach in permanent teeth (Phantumvanit et al., 1996). Because of the lack of information on the longevity of ART restorations, the Regional WHO Centre in Damascus started a comparative randomized controlled clinical trial. The null hypothesis was that there is no difference in the survival percentages between restorations produced through the ART approach, with high-viscosity glass ionomer, and those produced through the traditional approach, with amalgam, after 6.3 years. This is the first trial comparing the two approaches over a period of more than 6 yrs.
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MATERIALS & METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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A convenience sample of grade 2 children who ranged from 6 to 9 yrs of age was taken from 49 schools situated in the vicinity of the WHO Regional Centre in Damascus. Each child was diagnosed for dental caries by three calibrated examiners. The prevalence of dental caries in the children examined was 57.6%. The mean DMFS and DMFT scores were 1.6 and 1.4, respectively.
The inclusion criteria for a child to enter the RCT were the presence of a dentinal lesion in a permanent tooth, without suspected pulp involvement, that had an opening wide enough for the smallest excavator to enter (Ø = 0.9 mm). There were no inclusion criteria set for the actual size of the cavity.
Implementation
Eight dentists, aided by a chair-side assistant, conducted this RCT in the well-equipped clinical department of the WHO Regional Centre during October–December, 1997. Prior to being treated, all children attended group oral health education sessions and were taught individually, by experienced oral health educators, how best to clean their teeth with fluoridated toothpaste. Teeth that had caries involving the pulp, but not included in the study, were extracted as part of the care routinely provided at the Centre.
Treatment Procedure
The conventional treatment procedure consisted of the removal of carious tissues with a rotary instrument, after which the cavity was filled with Avalloy® (Cavex, Haarlem, the Netherlands), a powder/liquid non-gamma 2 triturated amalgam. Cavities were prepared with the creation of retention niches, but without the "extension for prevention" concept. Metal bands and wedges were placed when class II cavities were filled. Isolation and washing/drying of teeth were achieved with the use of cotton wool rolls and through the use of suction and three-way syringe systems. This procedure was termed the "traditional approach" (TA). The ART approach consisted of the opening of the cavity with a dental hatchet, the removal of soft carious tooth tissues with an excavator, and the filling of the cavity and the adjacent pits and fissures with a glass-ionomer cement. Two brands of glass-ionomer cements were used: Fuji IX® (GC Europe, Leuven, Belgium) and Ketac Molar® (3M ESPE, Seefeld, Germany), both in a hand-mixed formula. The chair-side assistant mixed the glass-ionomer cements according to the manufacturers’ instructions. Conditioning of the cavity and adjacent pits and fissures, with cotton wool pellets, preceded the placement of the glass ionomer. Moisture isolation was achieved with the use of cotton wool rolls, and cavities were washed and dried with cotton wool pellets. Excess material was removed by means of an applier/carver instrument, and the restoration was coated with a layer of petroleum jelly (Frencken et al., 1996). Multiple-surface cavities were filled after the placement of plastic bands and wedges. Local anesthesia was rarely administered.
All dentists had previously participated in a related clinical trial studying the survival of ART and TA restorations in deciduous dentitions (Taifour et al., 2002). They had ample experience in applying the ART approach. The TA procedure was known and routinely practiced by all dentists.
All eligible children were randomly assigned by the principal investigator (DT) to one of the two treatments (ART or TA) with the use of a gender-stratified class list. In the case of ART, Fuji IX® was allocated in the first part (34%) and Ketac Molar® in the second part (64%) of the implementation period.
Evaluation
The evaluation of the restorations took place after 1.3, 2.3, 3.3, 4.3, and 6.3 yrs, according to defined criteria (Table 1
). The 5.3-year evaluation was not performed because of the war in neighboring Iraq. The ball end of the CPI probe (0.5 mm in diameter) was used to measure the deficiency at the restoration margin. Restorations scored code 0 and 1 were considered successful; codes 2–7 were considered failures. A caries lesion was recorded as present if the lesion had a detectable soft wall and/or soft floor and was considered a failure for the survival analysis. Visible debris and plaque were removed from the tooth surface with the aid of an explorer. Teeth were dried by means of an air syringe. The examination sites were well-illuminated. Both caries and restoration criteria were applied to each of the three sections into which the occlusal surface was arbitrarily divided.
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= 0.05. |
RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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Eighty-four children with 142 restorations were never evaluated (non-participation). There was no statistically significant difference (p > 0.05) between non-participating and participating children for the background variables age, gender, treatment procedure, restorative material, and operator.
Longitudinal Assessment Series
We used data from a total of 597 children, including 287 boys and 310 girls, to estimate survival percentages. The ART group consisted of 330 children and the TA group of 267 children. The total number of restorations eligible for evaluation was 975, including 539 ART restorations (of which 185 were made with Fuji IX and 354 restorations were made with Ketac Molar) and 436 amalgam restorations. These restorations consisted of 890 single surfaces and 85 multiple surfaces. The percentages of children with 1, 2, and 3 or more restorations were 58, 27, and 15, respectively. The mean number of restorations placed per child was 1.6 (SD = 0.9).
Handling of Longitudinal Data
Each of the 975 restorations was associated with the longitudinal evaluation series of its corresponding 7 (sub-) surfaces, which translates into 6825 different sequences of evaluation scores over the 6.3 yrs. These longitudinal series were clearly interpretable in 96.7% of the cases (no errors, censored, or a distinct moment of failure). In 2.0% of the longitudinal series, no distinct moment of failure could be specified (multi-interpretable), owing to missed observation occasions. In 1.3% of the cases, an error was encountered (i.e., regression of the restoration quality was detected). This situation could be corrected in 0.4% of the cases (almost uniquely interpretable) if a failed restoration was followed up by a recording that the restoration was sound at least two times. In the other 0.9% of the cases, the true failure could not be determined on the basis of the longitudinal series. An intelligent decision was made as to which evaluation year the failure was allocated. This process led to unique survival percentages at evaluation year 5.3.
Comparison of Treatment Approaches
All Types of Restorations
The modified actuarial cumulative survival percentages and standard errors (SE) for all types of restorations for both treatment approaches over the 6.3 yrs were calculated (Table 3). Higher survival percentages were observed for ART than for TA restorations at all intervals (Table 3). The differences in the survival percentages between the two groups were statistically significant at all intervals except for the first. The 6.3-year cumulative survival percentages of ART restorations with Fuji IX and Ketac Molar were 61.8% (SE = 6.0%) and 68.5% (SE = 3.6%), respectively, and this difference between the survival percentages of restorations made with the two brands of glass ionomer was not significantly significant (p = 0.34).
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). Higher survival percentages were observed for ART than for TA restorations at all intervals (Table 4). The difference between the survival percentages was statistically significant at all intervals except for the first and the third.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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The decision to opt for a parallel group design ensured that the number of restorations placed per treatment modality would differ. However, the difference in numbers of restorations placed per treatment group turned out to be larger than anticipated (NART = 539, NTA = 436). The reason for this was due to the fact that the electricity supply failed on several days. On those days, the principal investigator decided that all of the children, who had been transported to the WHO Centre for treatment, would be treated by the ART approach. We do not think that this decision biased the outcome of the study.
The survival percentages were analyzed at the restoration level. This assumed independence of the survival percentages of children. We applied the Jackknife method to deal with the dependency of restoration outcomes within each child; this resulted in higher SE values than those calculated through the commonly used Greenwood (1926) method.
The criteria used in the present study have been applied in most other ART studies in the permanent dentition (Frencken and Holmgren, 2004). Usually, the USPHS criteria are used for the assessment of restoration survival. Studies have shown no significant difference in survival outcomes of ART restorations that were evaluated according to both sets of criteria (Holmgren et al., 2000). Further, it has been suggested that the ART criteria are more stringent than the USPHS criteria (Lo et al., 2001). Thus, we may reasonably assume that the results of the present study are comparable with those from non-ART studies.
The percentage of restorations that survived after the end of each evaluation period was higher for the ART approach than for the amalgam approach group. Despite the fact that many restorations were lost to follow-up during the last two intervals, thus decreasing the power of the trial, the differences in the percentages of survival of restorations between the two treatment approaches were statistically significant at all intervals but the first. The null hypothesis was rejected: There is a difference in the percentage of restorations that survived produced through the ART approach, with high-viscosity glass ionomer, and those produced through the traditional approach, with amalgam, after 6.3 yrs. Survival percentages for ART restorations were higher than those for amalgam restorations after 6.3 yrs. This was also found to be true with the subset of single-surface restorations that showed higher survival percentages for ART than for amalgam restorations after 6.3 yrs.
The present study is the first in which ART restorations with high-viscosity glass ionomer were compared with traditionally produced restorations. The majority of the restorations were placed in single surfaces. There is one other study (in Tanzania) in which the ART approach was compared with the traditional approach, with amalgam in single surfaces in permanent dentitions, after 6 years (Mandari et al., 2003). The latter study reported no significant difference between the two approaches, but amalgam restorations performed better than ART restorations. The ART restorations in the Tanzanian study were placed by one dental therapist, who used a medium-viscosity glass-ionomer cement. Whether these two aspects contributed to the difference in final outcome between the Tanzanian and the present study is uncertain.
The cumulative survival percentage (68.9%) of single-surface ART restorations after 6.3 yrs in the present study is equal to that (68.6%) reported from Tanzania (Mandari et al., 2003).
In recent years, few studies have reported on the placement of single-surface amalgam restorations by multiple dentists. The median survival of one-surface amalgam restorations, placed by 22 general practitioners, has been reported to be 7.1 yrs (Mjör et al., 1997), whereas the median survival time for Class I amalgam restorations, placed by 73 dentists, has been reported to be 7.4 yrs (Burke et al., 1999). These results are in line with the 6.3-year cumulative survival percentage of single-surface amalgam restorations of 59.7% placed by eight dentists in the present study.
We conclude that the restorations produced with the ART approach, with high-viscosity glass ionomer, survived longer than those produced with the traditional approach, with amalgam, in the permanent teeth of young children. We recommend the ART approach as a complement to the preventive activities in the Syrian school oral health programs.
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ACKNOWLEDGMENTS |
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Received May 19, 2005; Last revision March 5, 2006; Accepted April 23, 2006
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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Efron B (1982). The jackknife, the bootstrap and other resampling plans. Philadelphia: SIAM-NSF.
Frencken JE, Holmgren CJ (2004). ART: a minimal intervention approach to manage dental caries. Dent Update 31:295–298, 301.[Medline]
Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P (1996). Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent 56(Spec Iss 3):135–140.[ISI][Medline]
Greenwood M (1926). The "errors of sampling" of the survivorship tables. Appendix 1. In: Reports on public health and medical subjects. No. 33. London, UK: Her Majesty’s Stationery Office.
Holmgren CJ, Lo EC, Hu D, Wan H (2000). ART restorations and sealants placed in Chinese school children—results after three years. Community Dent Oral Epidemiol 28:314–320.[ISI][Medline]
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Lo EC, Luo Y, Fan MW, Wei SH (2001). Clinical investigation of two glass-ionomer restoratives used with the atraumatic restorative treatment approach in China: two-year results. Caries Res 35:458–463.[ISI][Medline]
Mandari GJ, Frencken JE, van ‘t Hof MA (2003). Six-year success rates of occlusal amalgam and glass-ionomer restorations placed using three minimal intervention approaches. Caries Res 37:246–253.[Medline]
Mjör IA, Burke FJ, Wilson NH (1997). The relative cost of different restorations in the UK. Br Dent J 182:286–289.[ISI][Medline]
Phantumvanit P, Songpaisan Y, Pilot T, Frencken JE (1996). Atraumatic restorative treatment (ART): a three-year community field trial in Thailand—survival of one-surface restorations in the permanent dentition. J Public Health Dent 56(Spec Iss 3):141–145.[Medline]
Taifour D (2002). Effectiveness of the ART approach in a child population in Syria (dissertation). Nijmegen, the Netherlands: Radboud University.
Taifour D, Frencken JE, Beiruti N, van ‘t Hof MA, Truin GJ (2002). Effectiveness of glass-ionomer (ART) and amalgam restorations in the deciduous dentition—results after 3 years. Caries Res 36:437–444.[Medline]
Taifour D, Frencken JE, Beiruti N, van ‘t Hof MA, Truin GJ, Van Palenstein Helderman WH (2003). Comparison between restorations in the permanent dentition produced by hand and rotary instrumentation—survival after 3 years. Community Dent Oral Epidemiol 31:122–128.[Medline]
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