Marginal Biofilm Distribution and Periodontal Response to Supragingival and Juxtagingival Aligner Designs (BIOFILM-ALIGN)
2026年7月15日 更新者：Emilia Rusu、George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Marginal Biofilm Distribution and Periodontal Response to Supragingival and Juxtagingival Aligner Designs: A Prospective Split-Mouth Clinical Study
- This prospective, longitudinal, within-person (split-mouth) clinical study evaluates the influence of two clear aligner trimming-line designs on marginal soft-tissue biofilm distribution and periodontal tissue response over a six-month period.
- Two trimming-line designs are compared. The supragingival design has a straight, horizontal edge that extends approximately 2 mm onto the marginal gingiva, resting in direct contact with the gingival surface but not entering the gingival sulcus. The juxtagingival design follows the scalloped contour of the gingival margin and terminates at the free gingival margin, without covering the gingiva and without entering the sulcus.
- Each participant receives both designs simultaneously, one per dental arch, and therefore serves as their own control. The assignment of each design to an arch is determined by the treating clinician according to the orthodontic treatment indications and is not randomized.
- The primary outcome is the percentage of sites with bleeding on probing per arch at six months. Secondary outcomes are bleeding on probing at three months, mean probing depth, maximum probing depth, and the Turesky-Quigley-Hein plaque index, with three exploratory photographic soft-tissue variables describing marginal gingival plaque presence, vestibular interdental papilla plaque presence, and the marginal demarcation pattern. Clinical and photographic assessments are performed at baseline (before aligner delivery), at three months, and at six months.
- All aligners are fabricated from a tri-layer clear aligner material (CA Pro, SCHEU-DENTAL GmbH, Iserlohn, Germany) by a single orthodontic laboratory.
調査の概要
状態
完了
詳細な説明
- BACKGROUND AND RATIONALE
- Clear aligner therapy is widely used in contemporary orthodontics. The geometry of the aligner trimming line at the gingival margin differs between two commonly used designs: a supragingival design that covers a band of marginal gingiva, and a juxtagingival design that follows the gingival contour. Biomechanical investigations have characterized how trimming-line geometry affects force transmission and retention, and a limited number of clinical reports have examined its periodontal effects. However, direct clinical comparisons of trimming-line geometry on periodontal outcomes remain scarce and have been limited largely to adolescent populations and to conventional periodontal indices; within-person comparisons in adults, and the distribution of biofilm on the marginal soft tissues, remain insufficiently characterized. This study addresses that gap.
- THE TWO TRIMMING-LINE DESIGNS The supragingival design has a straight, horizontal edge that extends approximately 2 mm onto the marginal gingiva, resting in direct contact with the gingival surface but not entering the gingival sulcus. The juxtagingival design follows the scalloped contour of the gingival margin and terminates at the free gingival margin, without covering the gingiva and without entering the sulcus. Both designs are produced from the same CE-marked tri-layer clear aligner material (CA Pro, SCHEU-DENTAL GmbH, Iserlohn, Germany) and are standard variations used in routine orthodontic practice. The intervention under study is the trimming-line design, a manufacturing parameter, not the aligner material or device itself.
- STUDY DESIGN This is a prospective, longitudinal, within-person (split-mouth) interventional study. Each participant receives both trimming-line designs simultaneously, one on the maxillary arch and one on the mandibular arch, and therefore serves as their own control. The unit of comparison is the dental arch within the participant. The split-mouth design controls for inter-individual variation in systemic health, oral hygiene, salivary characteristics, and baseline periodontal status. The within-person (split-mouth) design was chosen to maximize statistical efficiency in an exploratory clinical evaluation, with each participant serving as their own control.
- ALLOCATION RULE (NON-RANDOMIZED) Allocation of each design to an arch is not randomized. It follows a pre-specified rule based on the orthodontic treatment plan. The primary criterion is the magnitude of planned dental intrusion per arch, derived from the digital treatment setup prepared before aligner fabrication: the arch with the greater planned intrusion receives the supragingival design. When planned intrusion is equal on both arches or absent, a pre-specified alternating sequence in enrollment order is applied as a tiebreaker, with the first such participant receiving the supragingival design on the maxillary arch, the next on the mandibular arch, and so on. This produces an approximately balanced arch-level distribution. Planned intrusion magnitude is used only as the basis for this allocation rule; it is not entered as a covariate in the analysis, and the study does not analyze the relationship between intrusion magnitude and hard-tissue outcomes (root or alveolar bone).
- CLINICAL AND PHOTOGRAPHIC ASSESSMENTS Assessments are performed at baseline before aligner delivery (T0), at three months (T1, plus or minus 7 days), and at six months (T2, plus or minus 7 days). At each visit, full-mouth periodontal charting (probing depth and bleeding on probing) is performed first, on undisclosed tissue, by a calibrated examiner who is blinded to the trimming-line allocation; conventional plaque assessment is then performed using a two-tone disclosing agent and the Turesky-Quigley-Hein plaque index; and standardized intraoral photographs are obtained afterwards.
- EXPLORATORY PHOTOGRAPHIC VARIABLES Three photographic soft-tissue variables, namely marginal gingival plaque presence, vestibular interdental papilla plaque presence, and the marginal demarcation pattern, were developed for this study to describe the distribution of biofilm on the marginal gingival soft tissues, a dimension not captured by conventional hard-surface plaque indices. These variables are designated as exploratory. The photographs are de-identified, coded, and presented in randomized order to two independent blinded examiners, and inter-examiner agreement is assessed using the Cohen kappa coefficient.
- ANALYSIS The primary comparison is the within-person, between-arch difference in the percentage of sites with bleeding on probing at six months (T2), with baseline (T0) as the reference and each participant serving as their own control. The three-month (T1) assessment is analyzed as a secondary, intermediate time point describing the trajectory of periodontal response. The secondary validated outcomes, probing depth and the plaque index, are analyzed within the same within-person framework across all time points. The exploratory photographic variables are summarized descriptively, and their effect estimates are reported to inform the design of future confirmatory studies. All tests are two-sided, with the significance level set at 0.05.
- SAFETY Both trimming-line designs are standard variations used in routine clinical orthodontic practice with a CE-marked aligner material, and neither constitutes a novel or experimental device. Untoward periodontal or soft-tissue events occurring during the study are recorded at each scheduled visit and may be reported by participants between visits. Predefined clinical criteria are applied for the withdrawal of a participant when continued participation would no longer be in the participant's clinical interest.
- LIMITATIONS Allocation is not randomized and is tied to the planned intrusion per arch. Because intrusion magnitude is not adjusted for in the analysis, between-arch differences may partly reflect the clinically driven allocation rather than the trimming-line design alone; this is acknowledged in the interpretation of the results. The split-mouth design reduces inter-individual variation but cannot exclude arch-level biomechanical differences other than the trimming-line design.
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Sibiu County
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Sibiu、Sibiu County、ルーマニア、550027
- Aorys Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Permanent dentition
- Adult patients
- Mild to moderate crowding not requiring extractions for orthodontic purposes
Exclusion Criteria:
- Mouth breathing (may influence the status of the marginal periodontium)
- Periodontal involvement (gingivitis or periodontitis)
- Presence of fixed prosthetic restorations with incorrect marginal adaptation
- Deficient oral hygiene
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Supragingival Trimming-Line Design
Dental arch fitted with a clear aligner trimmed with a supragingival straight-cut margin.
The aligner edge extends approximately 2 mm onto the marginal gingiva, in direct contact with the gingival surface but without entering the gingival sulcus.
Assigned to the arch with the greater planned intrusion; when planned intrusion is equal or absent on both arches, assignment follows a pre-specified alternating sequence in enrollment order.
|
Clear aligner trimmed with a supragingival straight-cut margin extending approximately 2 mm onto the marginal gingiva, in direct contact with the gingiva but not entering the sulcus.
Fabricated from CA Pro tri-layer thermoplastic material (SCHEU-DENTAL GmbH, Iserlohn, Germany; CE-marked) by Orto Performance Orthodontic Laboratory, Cluj-Napoca, Romania.
The intervention under study is the trimming-line design, not the aligner material; material and thickness are identical to the comparator.
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アクティブコンパレータ：Juxtagingival Festooned Trimming-Line Design
Contralateral dental arch, within the same participant, fitted with a clear aligner trimmed with a juxtagingival festooned margin that follows the scalloped contour of the gingival margin and terminates at the free gingival margin, without covering the gingiva and without entering the sulcus.
Assigned to the arch with the lesser or no planned intrusion.
|
Clear aligner trimmed with a juxtagingival festooned margin following the scalloped gingival contour, terminating at the free gingival margin without covering the gingiva or entering the sulcus.
Fabricated from CA Pro tri-layer thermoplastic material (SCHEU-DENTAL GmbH, Iserlohn, Germany; CE-marked) by Orto Performance Orthodontic Laboratory, Cluj-Napoca, Romania.
The intervention under study is the trimming-line design, not the aligner material; material and thickness are identical to the comparator.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bleeding on probing at 6 months (percentage of sites per arch)
時間枠：Baseline (T0, before aligner delivery) and 6 months (T2)
|
Percentage of sites with bleeding on probing within each dental arch.
Bleeding on probing is recorded as present or absent within approximately 10 to 15 seconds after gentle probing at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, distolingual) using a calibrated periodontal probe.
The percentage is calculated as the number of bleeding sites divided by the total number of scorable sites in the arch, multiplied by 100.
The two arches within each participant are compared by trimming-line design.
The primary endpoint is the within-person, between-arch difference at 6 months (T2), with baseline (T0) as the reference.
The 3-month (T1) assessment is analyzed as a secondary, intermediate time point and does not contribute to the primary comparison.
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Baseline (T0, before aligner delivery) and 6 months (T2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bleeding on probing at 3 months (intermediate, percentage of sites per arch)
時間枠：3 months (T1)
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Percentage of sites with bleeding on probing within each dental arch at the 3-month assessment, recorded and computed identically to the primary outcome (six sites per tooth, present or absent within approximately 10 to 15 seconds of gentle probing), compared between arches by trimming-line design.
This intermediate time point describes the trajectory of periodontal response and is not the primary comparison.
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3 months (T1)
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Mean probing depth (per arch)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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Arithmetic mean of probing depth values (mm) within each dental arch, measured at six sites per tooth using a calibrated periodontal probe, calculated separately for each arch and compared by trimming-line design.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Maximum probing depth (per arch)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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The greatest single probing depth value (mm) recorded within each dental arch, calculated separately for each arch and compared by trimming-line design.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Turesky-Quigley-Hein plaque index (per arch)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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Mean plaque score on the Turesky-Quigley-Hein ordinal scale (0 to 5), recorded on the vestibular surfaces of teeth after application of a two-tone plaque-disclosing agent (Rondell, Directa AB, Sweden), calculated separately for each dental arch and compared by trimming-line design.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Marginal Gingival Plaque Presence (MGPP%)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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Percentage of tooth-associated gingival units showing disclosed plaque on the vestibular aspect of the free gingival margin (within 0 to 2 mm of the gingival crest), scored as present or absent per unit from standardized intraoral photographs by two independent blinded examiners, calculated per arch.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Vestibular Interdental Papilla Plaque Presence (VIPPP%)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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Percentage of interdental papillary units showing disclosed plaque on the visible vestibular aspect of the interdental papilla, scored as present or absent per unit from standardized intraoral photographs by two independent blinded examiners, calculated per arch.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Marginal Demarcation Pattern (MDP)
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2)
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Categorical classification of the predominant pattern of disclosed marginal plaque distribution on the buccal gingiva, scored per arch from standardized intraoral photographs by two independent examiners blinded to allocation.
The categories are morphological, not ordinal severity levels: 0 = absent (no disclosed plaque pattern on the marginal gingiva); 1 = diffuse (disclosed plaque scattered over the gingiva without a defined coronal outline); 2 = papillary (disclosed plaque confined to the interdental papillae); 3 = linear/band (a continuous, clearly demarcated horizontal band of disclosed plaque spanning the buccal aspect of two or more adjacent teeth, including the papilla between them).
The numeric codes denote distinct categories and not increasing severity; the predominant pattern is recorded for each arch.
Inter-examiner agreement is assessed using the Cohen kappa coefficient for nominal categories.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：LUMINITA LAZAR, PhD, Professor、George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Rouzi M, Zhang X, Jiang Q, Long H, Lai W, Li X. Impact of Clear Aligners on Oral Health and Oral Microbiome During Orthodontic Treatment. Int Dent J. 2023 Oct;73(5):603-611. doi: 10.1016/j.identj.2023.03.012. Epub 2023 Apr 25.
- Elshazly TM, Keilig L, Salvatori D, Chavanne P, Aldesoki M, Bourauel C. Effect of trimming line design and edge extension of orthodontic aligners on force transmission: An in vitro study. J Dent. 2022 Oct;125:104276. doi: 10.1016/j.jdent.2022.104276. Epub 2022 Aug 30.
- Rusu EP, Lazar AP, Erhan BL, Bud E, Pacurar M, Lazar L. Clear Aligner Therapy and Marginal Edge Design: Clinical and Laboratory Evidence on Periodontal and Biological Outcomes-A Scoping Review. Dent J (Basel). 2026 Feb 24;14(3):130. doi: 10.3390/dj14030130.
- Crego-Ruiz M, Jorba-Garcia A. Assessment of the periodontal health status and gingival recession during orthodontic treatment with clear aligners and fixed appliances: A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2023 Jul 1;28(4):e330-e340. doi: 10.4317/medoral.25760.
- Favero R, Libralato L, Balestro F, Volpato A, Favero L. Edge level of aligners and periodontal health: a clinical perspective study in young patients. Dental Press J Orthod. 2023 Apr 14;28(1):e2321124. doi: 10.1590/2177-6709.28.1.e2321124.oar. eCollection 2023.
- Espana-Pamplona P, Bernes-Martinez L, Andres-Castello C, Bolas-Colvee B, Adobes-Martin M, Garcovich D. Changes in the Oral Microbiota with the Use of Aligners vs. Braces: A Systematic Review. J Clin Med. 2024 Dec 6;13(23):7435. doi: 10.3390/jcm13237435.
- Lyu X, Cao X, Yan J, Zeng R, Tan J. Biomechanical effects of clear aligners with different thicknesses and gingival-margin morphology for appliance design optimization. Am J Orthod Dentofacial Orthop. 2023 Aug;164(2):239-252. doi: 10.1016/j.ajodo.2022.12.014. Epub 2023 Mar 21.
- Elshazly TM, Bourauel C, Chavanne P, Elattar H, Keilig L. Numerical biomechanical finite element analysis of different trimming line designs of orthodontic aligners: An in silico study. J World Fed Orthod. 2024 Apr;13(2):65-71. doi: 10.1016/j.ejwf.2024.01.001. Epub 2024 Feb 23.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年3月1日
一次修了 (実際)
2026年7月15日
研究の完了 (実際)
2026年7月15日
試験登録日
最初に提出
2026年6月6日
QC基準を満たした最初の提出物
2026年6月6日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- BIOFILM ALIGN-ORTHO
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be made publicly available, as the small single-site cohort (20 participants) cannot be fully de-identified without risk to participant confidentiality.
De-identified data may be made available from the principal investigator on reasonable academic request, subject to an appropriate data-sharing agreement and ethics approval.
Aggregate results will be reported in the doctoral thesis and in peer-reviewed publication.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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