Intervention Review

Guided tissue regeneration for periodontal infra-bony defects

  1. Ian Needleman1,*,
  2. Helen V Worthington2,
  3. Elaine Giedrys-Leeper1,
  4. Richard Tucker1

Editorial Group: Cochrane Oral Health Group

Published Online: 8 OCT 2008

Assessed as up-to-date: 12 JAN 2006

DOI: 10.1002/14651858.CD001724.pub2

Database Title

Additional Information

How to Cite

Needleman I, Worthington HV, Giedrys-Leeper E, Tucker R. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD001724. DOI: 10.1002/14651858.CD001724.pub2.

Author Information

  1. 1

    UCL Eastman Dental Institute, Unit of Periodontology, Division of Restorative Dental Sciences, London, UK

  2. 2

    School of Dentistry, The University of Manchester, Cochrane Oral Health Group, MANDEC, Manchester, UK

*Ian Needleman, Unit of Periodontology, Division of Restorative Dental Sciences, UCL Eastman Dental Institute, University College London (UCL), University of London, 256 Gray's Inn Road, London, WC1X 8LD, UK. i.needleman@eastman.ucl.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 8 OCT 2008

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Conventional treatment of destructive periodontal (gum) disease arrests the disease but does not usually regain the bone support or connective tissue lost in the disease process. Guided tissue regeneration (GTR) is a surgical procedure that specifically aims to regenerate the periodontal tissues when the disease is advanced and could overcome some of the limitations of conventional therapy.

Objectives

To assess the efficacy of GTR in the treatment of periodontal infra-bony defects measured against conventional surgery (open flap debridement (OFD)) and factors affecting outcomes.

Search methods

We conducted an electronic search of the Cochrane Oral Health Group Trials Register, MEDLINE and EMBASE up to April 2004. Handsearching included Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research and bibliographies of all relevant papers and review articles up to April 2004. In addition, we contacted experts/groups/companies involved in surgical research to find other trials or unpublished material or to clarify ambiguous or missing data and posted requests for data on two periodontal electronic discussion groups.

Selection criteria

Randomised, controlled trials (RCTs) of at least 12 months duration comparing guided tissue regeneration (with or without graft materials) with open flap debridement for the treatment of periodontal infra-bony defects. Furcation involvements and studies specifically treating aggressive periodontitis were excluded.

Data collection and analysis

Screening of possible studies and data extraction was conducted independently. The methodological quality of studies was assessed in duplicate using individual components and agreement determined by Kappa scores. Methodological quality was used in sensitivity analyses to test the robustness of the conclusions. The Cochrane Collaboration statistical guidelines were followed and the results expressed as mean differences (MD and 95% CI) for continuous outcomes and risk ratios (RR and 95% CI) for dichotomous outcomes calculated using random-effects models. Any heterogeneity was investigated. The primary outcome measure was change in clinical attachment.

Main results

The search produced 626 titles, of these 596 were clearly not relevant to the review. The full text of 32 studies of possible relevance was obtained and 15 studies were excluded. Therefore 17 RCTs were included in this review, 16 studies testing GTR alone and two testing GTR + bone substitutes (one study had both test treatment arms).

No tooth loss was reported in any study although these data are incomplete where patient follow up was not complete. For attachment level change, the mean difference between GTR and OFD was 1.22 mm (95% CI Random Effects: 0.80 to 1.64, Chi2 for heterogeneity 69.1 (df = 15), P < 0.001, I2 = 78%) and for GTR + bone substitutes was 1.25 mm (95% CI 0.89 to 1.61, Chi2 for heterogeneity 0.01 (df = 1), P = 0.91). GTR showed a significant benefit when comparing the numbers of sites failing to gain 2 mm attachment with risk ratio 0.54 (95% CI Random Effects: 0.31 to 0.96, Chi2 for heterogeneity 8.9 (df = 5), P = 0.11). The number needed to treat (NNT) for GTR to achieve one extra site gaining 2 mm or more attachment over open flap debridement was therefore 8 (95% CI 5 to 33), based on an incidence of 28% of sites in the control group failing to gain 2 mm or more of attachment. For baseline incidences in the range of the control groups of 3% and 55% the NNTs are 71 and 4.

Probing depth reduction was greater for GTR than OFD: 1.21 mm (95% CI 0.53 to 1.88, Chi2 for heterogeneity 62.9 (df = 10), P < 0.001, I2 = 84%) or GTR + bone substitutes, weighted mean difference 1.24 mm (95% CI 0.89 to 1.59, Chi2 for heterogeneity 0.03 (df = 1), P = 0.85).

For gingival recession, a statistically significant difference between GTR and open flap debridement controls was evident (mean difference 0.26 mm (95% CI Random Effects: 0.08, 0.43, Chi2 for heterogeneity 2.7 (df = 8), P = 0.95), with a greater change in recession from baseline for the control group.

Regarding hard tissue probing at surgical re-entry, a statistically significant greater gain was found for GTR compared with open flap debridement. This amounted to a weighted mean difference of 1.39 mm (95% CI 1.08 to 1.71, Chi2 for heterogeneity 0.85 (df = 2), P = 0.65). For GTR + bone substitutes the difference was greater, with mean difference 3.37 mm (95% CI 3.14 to 3.61).

Adverse effects were generally minor although with an increased treatment time for GTR. Exposure of the barrier membrane was frequently reported with a lack of evidence of an effect on healing.

Authors' conclusions

GTR has a greater effect on probing measures of periodontal treatment than open flap debridement, including improved attachment gain, reduced pocket depth, less increase in gingival recession and more gain in hard tissue probing at re-entry surgery. However there is marked variability between studies and the clinical relevance of these changes is unknown. As a result, it is difficult to draw general conclusions about the clinical benefit of GTR. Whilst there is evidence that GTR can demonstrate a significant improvement over conventional open flap surgery, the factors affecting outcomes are unclear from the literature and these might include study conduct issues such as bias. Therefore, patients and health professionals need to consider the predictability of the technique compared with other methods of treatment before making final decisions on use. Since trial reports were often incomplete, we recommend that future trials should follow the CONSORT statement both in their conduct and reporting.

There is therefore little value in future research repeating simple, small efficacy studies. The priority should be to identify factors associated with improved outcomes as well as investigating outcomes relevant to patients. Types of research might include large observational studies to generate hypotheses for testing in clinical trials, qualitative studies on patient-centred outcomes and trials exploring innovative analytic methods such as multilevel modelling. Open flap surgery should remain the control comparison in these studies.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Guided tissue regeneration for periodontal infra-bony defects

Current treatments for destructive periodontal (gum) disease are not able to restore damaged bone and connective tissue support for teeth. There are therefore limitations in treating patients with advanced disease. The surgical technique, guided tissue regeneration (GTR) may be able to achieve regeneration and therefore improve upon conventional surgical results. The results of this review have shown some advantage to using GTR in infra-bony defects but with wide variations in the benefits achievable compared with conventional surgery. We were unable to identify conclusively factors responsible for this variability. Therefore, patients and health professionals need to consider the predictability of the technique compared with other methods of treatment before making final decisions on use. Adverse effects of treatment were generally minor and similar between groups although with an increased treatment time for GTR. We recommend further research to address the issue of variability and to identify which characteristics of the disease or the patient are more clearly associated with a beneficial outcome.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

引導組織再生治療牙周基礎骨缺損

對破壞性牙周(牙齦)病的傳統療法可治療疾病但不能回復疾病過程中骨頭或連結組織的損失.引導組織再生(GTR)是手術療程,特別為了於疾病惡化時再生牙周組織,可克服一些傳統療法的限制

目標

評估引導組織再生治療牙周基礎骨缺損的療效,與傳統手術(翻瓣清創(OFD))相比和影響結果的其他因子

搜尋策略

電子搜尋2004/4月前的the Cochrane Oral Health Group Trials Register, MEDLINE和 EMBASE.手動搜尋2004/4月 Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research 和相關文獻的引用清單.此外,連絡與手術研究相關的專家/團體/公司,取得其他試驗或未發表試驗,在2牙周電子討論群,釐清不清楚或缺少的資料.

選擇標準

至少為期12個月的隨機對照試驗,比較以翻瓣清創進行引導組織再生(有或沒有使用移植材料)治療牙周基礎骨缺損.排除牙根分叉處破壞和專門研究侵襲性牙周炎的試驗

資料收集與分析

獨立檢視可能試驗和擷取資料.方法學品質依各別組成與Kappa指數取決來重複評估.方法學品質以敏感度分析檢測結論強度.遵守Cochrane Oral Health Group 統計準則,連續變項之結果以平均差和95% CI代表,二元變項之結果採用隨機效果模式計算,以RR和95% CI表示.檢測異質性.主要結果變項為臨床附著改變程度.

主要結論

找到626 文獻題目,其中596篇明顯與本回顧無關.取得32 篇可能相關研究的全文,排除15 個研究.因此本回顧納入17 個隨機對照試驗,其中16個只研究引導組織再生,兩個研究引導組織再生併用骨替代品(1試驗兩組都有).雖然試驗資料與病患追蹤都不完整,但無缺牙的報告,病患追蹤不完整. 附著狀況的改變方面, 引導組織再生和 OFD兩組平均差為1.22 公釐 (隨機效果95% CI: 0.80−1.64, 卡方異質性檢定69.1 (自由度 = 15), P < 0.001, I2 = 78%),引導組織再生加上骨替代品組則為1.25 公釐 (95% CI 0.89−1.61, 卡方異質性檢定 0.01 (自由度為 1), P = 0.91). 在比較附著增量低於2 公釐的區塊數目,引導組織再生顯著有效, RR 0.54 (95%隨機效果CI 0.31−0.96,卡方異質性檢定 8.9 (自由度為 5), P = 0.11).與翻瓣清創比較,引導組織再生達到附著增量2公釐以上的需治數為8 (95% CI 5−33),分析中對照組附著增量低於2 公釐的發生率為28%. 對照組基期發生率為3%或 55%時,益一需治數為71和 4. 引導組織再生組的牙周袋探診深度降低勝過OFD,為 1.21公釐 (95% CI 0.53−1.88,卡方異質性檢定 62.9 (自由度為 10), P < 0.001, I2 = 84%)而引導組織再生加上骨替代品,其加權平均差為 1.24 公釐(95% CI 0.89−1.59, 卡方異質性檢定 0.03 (自由度為 1), P = 0.85). 引導組織再生組和翻瓣清創對照組在牙齦退縮有顯著差異, (平均差 0.26公釐 (95% CI 隨機效果: 0.08, 0.43,卡方異質性檢定 2.7 (自由度為 8), P = 0.95), 對照組基期改變較大. 對於再次手術時硬組織方面,與翻瓣清創組相比, 引導組織再生組的進步顯著較大. 加權平均差為1.39 公釐 (95% CI 1.08−1.71, 卡方異質性檢定 0.85 (自由度為 2), P = 0.65).引導組織再生加上骨替代品組的差異更大,平均差 3.37 公釐 (95% CI 3.14−3.61).即使引導組織再生治療時間增長,副作用仍較輕微.常有再生膜外露的報告,對癒合不影響

作者結論

引導組織再生對牙周治療的優於翻瓣清創,包含改進附著, 降低囊深,較少牙齦退縮惡化和再次手術時硬組織的增加. 但試驗間差異大,其臨床相關性未知.因此,難以得到關於引導組織再生益處的一般性結論. 引導組織再生明顯顯著優於傳統開瓣手術, 文獻中影響結果變項不明,可能包含試驗執行誤差.因此,病患和醫療人員需考慮與其他技術相比的預測性,再決定採取和療法.試驗報告通常不夠完整,建議未來試驗的執行和報告應遵守CONSORT 聲明.未來研究若繼續重複簡單,小型效果試驗,則其貢獻不大.最重要的應該是找出與改進結果相關的變項和與病患相關的研究變項.試驗種類可包含大型觀察性試驗,以做出臨床試驗的檢定假設,病患為中心的量化試驗,創新分析方式的研究,如多模型. 開瓣手術仍採為對照組

翻譯人

本摘要由成功大學附設醫院尹子真翻譯。

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

總結

對破壞性牙周(牙齦)病的現有療法不能回復骨頭或結締組織的損失.疾病惡化的病患有治療上的限制.手術技術引導組織再生(GTR),可能可以再生牙周組織,改進傳統療法.本回顧顯示引導組織再生用於牙周基礎骨缺損優於傳統手術,但優勢變異大.無法結論哪些因子造成這種變異.病患和醫療人員需考慮與其他技術相比的預測性,再決定採取和療法.即使引導組織再生治療時間增長,副作用仍較輕微.建議未來試驗研究變異性並找出與較佳結果變項較相關的疾病特性或病患

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