Dental fillings for the treatment of caries in the primary dentition

 

Abstract

Background

Childhood caries (tooth decay) consists of a form of tooth decay that affects the milk teeth (also known as baby or primary teeth) of children. This may range from tooth decay in a single tooth to rampant caries affecting all the teeth in the mouth. Primary teeth in young children are vital to their development and every effort should be made to retain these teeth for as long as is possible. Dental fillings or restorations have been used as an intervention to repair these damaged teeth. Oral health professionals need to make astute decisions about the type of restorative (filling) material they choose to best manage their patients with childhood caries. This decision is by no means an easy one as remarkable advances in dental restorative materials over the last 10 years has seen the introduction of a multitude of different filling materials claiming to provide the best performance in terms of durability, aesthetics, symptom relief, etc when placed in the mouth. This review sought to compare the different types of dental materials against each other for the same outcomes.

Objectives

The objective of this review was to compare the outcomes (including pain relief, survival and aesthetics) for restorative materials used to treat caries in the primary dentition in children.  Additionally, the restoration of teeth was compared with extraction and no treatment.

Search methods

Electronic searches of the following databases were undertaken: the Cochrane Oral Health Group's Trials Register (up to January 2009); CENTRAL (The Cochrane Library 2009, Issue1); MEDLINE (1966 to January 2009); EMBASE (1996 to January 2009); SIGLE (1976 to 2004); and conference proceedings on early childhood caries, restorative materials for paediatric dentistry, and material sciences conferences for dental materials used for children's dentistry (1990 to 2008). The searches attempted to identify all relevant studies irrespective of language.

Additionally, the reference lists from articles of eligible papers were searched, handsearching of key journals was undertaken, and personal communication with authors and manufacturers of dental materials was initiated to increase the pool of suitable trials (both published and unpublished) for inclusion into this review.

Selection criteria

Randomised controlled trials (RCTs) or quasi-randomised controlled trials with a minimum period of 6 months follow up were included. Both parallel group and split-mouth study designs were considered. The unit of randomisation could be the individual, group (school, school class, etc), tooth or tooth pair. Included studies had a drop-out rate of less than 30%. The eligible trials consisted of young children (children less than 12 years) with tooth decay involving at least one tooth in the primary dentition which was symptomatic or symptom free at the start of the study.

Data collection and analysis

Data were independently extracted, in duplicate, by two review authors. Disagreements were resolved by consultation with a third review author. Authors were contacted for missing or unclear information regarding randomisation, allocation sequence, presentation of data, etc. A quality assessment of included trials was undertaken. The Cochrane Collaboration statistical guidelines were followed for data analysis.

Main results

Only three studies were included in this review. The Fuks 1999 study assessed the clinical performance of aesthetic crowns versus conventional stainless steel crowns in 11 children who had at least two mandibular primary molars that required a crown restoration. The outcomes assessed at 6 months included gingival health (odds ratio (OR) 0.3; 95% confidence interval (CI) 0.01 to 8.32), restoration failure (OR 3.29; 95% CI 0.12 to 89.81), occlusion, proximal contact and marginal integrity. The odds ratios for occlusion, proximal contact and marginal integrity could not be estimated as no events were recorded at the 6-month evaluation. The Donly 1999 split-mouth study compared a resin-modified glass ionomer (Vitremer) with amalgam over a 36-month period. Forty pairs of Class II restorations were placed in 40 patients (21 males; 19 females; mean age 8 years +/- 1.17; age range 6 to 9 years). Although the study period was 3 years (36 months), only the 6- and 12-month results are reported due to the loss to follow up of patients being greater than 30% for the 24- and 36-month data. Marks 1999a recruited 30 patients (age range 4 to 9 years; mean age 6.7 years, standard deviation 2.3) with one pair of primary molars that required a Class II restoration. The materials tested were Dyract (compomer) and Tytin (amalgam). Loss to follow up at 24 and 36 months was 20% and 43% respectively. This meant that only the 24-month data were useable. For all of the outcomes compared in all three studies, there were no significant differences in clinical performance between the materials tested.

No studies were found that compared restorations versus extractions or no treatment as an intervention in children with childhood caries.

Authors' conclusions

It was disappointing that only three trials that compared three different types of materials were suitable for inclusion into this review. There were no significant differences found in all three trials for all of the outcomes assessed. Well designed, randomised controlled trials comparing the different types of filling materials for similar outcomes are urgently needed in dentistry. There was insufficient evidence from the three included trials to make any recommendations about which filling material to use.

 

Plain language summary

Dental fillings for the treatment of caries in the primary dentition

Dental fillings are placed routinely in children who have tooth decay all over the world. It was disappointing to note that so few trials could be included into this review that sought to compare different dental fillings for the same type of outcome. More studies are required that will assist dentists and their patients to make informed decisions on the best type of dental filling to use in a particular situation.

There is an urgent need in dentistry for well designed, randomised controlled trials to compare the different types of filling materials for similar outcomes. Methodological issues around study design, data presentation and statistical analyses of split-mouth and parallel group trials must be addressed by significantly improving adherence to CONSORT guidelines, and increasing collaboration between statisticians and investigators (clinicians and/or researchers) in all aspects of trial development, implementation, analyses and write-ups for publication. Recent publications have also highlighted the need for a standardized approach to evaluation criteria for fillings, outcomes, statistical tests, calibration, etc so that published evidence can be easily interpreted and collated in systematic reviews which is essential to guide clinical practice in an era of greater choices for both clinicians and patients.

 

摘要

背景

使用牙科填補材料治療乳牙齒列齲齒

孩童齲齒(蛀牙)是一種影響孩童乳牙齒列的齲齒型式.其可能包含單一牙齒蛀牙或到全口猛爆性齲齒.小朋友的乳牙對於其發育很重要,必須要盡一切努力去保存牙齒.牙科填補材或是充填材料已被用來修復這些受損的牙齒.口腔衛生專業人員必須對所要選用何種填補(充填)材料是對於患有孩童齲齒的病患是最好的做出機敏的決定. 由於牙科填補(充填)材料的發展,造就出許多不同的充填材料, 無疑是過去十年來一項相當大的進步, 這些不同的充填材料能提供在口腔內最佳的耐久性,美觀度,減低症狀等等的良好成效.本篇文獻回顧希望去比較各種不同種類的牙科材料以及各類不同的使用時機.

目標

這篇文獻回顧的目的是要去比較不同牙科填補材料對於治療孩童乳牙齲齒(包括疼痛減輕,成功率以及美觀性)的結果.另外,被填補的牙齒會與拔掉的牙齒以及沒有做治療的牙齒拿來做比較.

搜尋策略

我們搜尋電子資料庫包括:the Cochrane Oral Health Group's Trials Register (直到 January 2009); CENTRAL (The Cochrane Library 2009, Issue1); MEDLINE (1966 to January 2009); EMBASE (1996 to January 2009); SIGLE (1976 to 2004);並蒐集1990 到2008年間早期嬰兒齲齒,兒童牙科填補材料,及對於使用在兒童牙科的牙科材料科學討論會的會議資料.我們還鑑定所有有關的研究論文,不論任何語言.另外,也搜尋在這些被選中的文章中所提及的參考文獻,也進行關鍵字文章的手動搜尋,並和作者以及牙科材料廠商做個別面談,來增加本篇文獻回顧已發表和未發表的合適文章數目.

選擇標準

隨機控制試驗(RCTs)或類隨機控制試驗包含至少六個月以上的追蹤時間才可被選入.平行和分裂嘴形式的研究設計(splitmouth study designs)都有被包括進去.隨機的單位可能是一個個體,群組(學校,班級等等)牙齒或一對牙齒.能被選入的研究只剩30%.有資格被選上的文獻是由小於12歲的孩童,至少有一顆以上的乳牙齒列齲齒,具有症狀或是沒有症狀這樣的條件下組成.

資料收集與分析

所得的資料分別由兩位文獻回顧作者一式兩份的(地)獨立取出.如有意見不一致,則由第三位文獻回顧作者出面商議解決.作者們接觸遺失或模糊的資訊就以隨機選擇,連續分配,數據呈現等等的方式整理.對於被選入的文章有做品質評估.並遵循Cochrane Collaboration statistical 的guidelines 做數據分析.

主要結論

只有三篇文獻有被選入在這篇文獻回顧中. Fuks 在1999年的研究中評估對具有至少兩顆以上需要牙冠復型的下顎乳臼齒的11歲孩童比較較具美觀性的牙冠與傳統乳牙不銹鋼牙冠的成效差異.六個月後的的結果顯示包含牙齦健康(odds ratio, OR)值為0.3; 95%信賴區間(confidence interval, CI) 0.01 to 8.32, 填補失敗restoration failure的OR值是 3.29; 95% CI值是0.12 to 89.81,以及咬合,鄰接面接觸和邊緣完整性的觀察.不過咬合,鄰接面接觸和邊緣完整性的odds ratios無法在6個月後的觀察評估中被記錄. Donly在1999年分裂嘴形式的研究(splitmouth study)比較樹脂修改過的玻璃離子聚合物(resinmodified glass ionomer, Vitremer)與銀粉(amalgam)長達36個月的追蹤.在40位病患(21名男性;19名女性;平均年齡8歲 +/− 1.17歲;年齡範圍在6到9歲之間)的40對Class II restorations做追蹤研究.雖然研究時間長達3年(36個月),卻只有6個月和12個月的數據被報告出來,因為24個月和36個月的病人缺診率已經達到30%以上. Marks在1999年針對30位病人(年齡範圍在4到9歲;平均年齡6.7歲,標準偏差(standard deviation)為 2.3)具有一對需要Class II restoration的乳牙臼齒做研究.而做測試的材料為Dyract (compomer) and Tytin(amalgam).24個月和36個月的病人缺診率分別達到20%以及43%以上.這表示只有24個月的追蹤資料能夠使用.比較這三個研究文獻中的所有結果,受測試的不同材料間並沒有顯著的臨床表現差異.並沒有找到針對患有乳牙齲齒的孩童,比較以填補,抑或以拔牙或不做治療之間的結果差異的研究文獻.

作者結論

比較令人遺憾的是,只有三篇比較不同材料的文章有被選入在此篇文獻回顧中.並且這三篇研究的結果評估都沒有顯著差異.具有適當設計,隨機控制試驗來探討不同種類的填補材料來探討此議題的研究是現今牙科界非常需要的.因為這三篇研究文獻並無法提供足夠證據去建議使用要何種填補材料.

翻譯人

本摘要由臺灣大學附設醫院王馨慧翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

使用牙科填補材料常規地治療乳牙齲齒的方式已經遍及全球.令人失望的是鮮少文獻能夠符合條件被選入這篇文獻回顧中,去比較不同牙科填補材料的填補效果.必須有更多文獻輔助牙醫師以及其病患去做特定情況下最好填補材料選擇的決定.並且現今也迫切需要適當設計,隨機控制試驗來探討不同種類的填補材料的填補效果.方法論的議題圍繞實驗設計,資料呈現,以及對平行數據或分裂嘴型(splitmouth)數據標準分析,其都必須嚴格遵守CONSORT guidelines,並增加統計學家與研究者(臨床工作者和/或研究者)之間的合作,從研究過程,完成,分析,撰寫到發表.最近的發表也同時注重標準化的方法去評估充填,結果,標準分析,分門別類等等的標準.所以已發表的證據能被容易地詮釋,並蒐集入標準的文獻回顧中,以導引臨床工作者及病患在臨床工作上有更多的選擇性.