Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study (COMFORT-ALIGN)
2026년 6월 18일 업데이트: Emilia Rusu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Comparison of Patient-Reported Comfort Between Supragingival and Juxtagingival Clear Aligner Trimming-Line Designs: A Cross-Sectional, Within-Subject Split-Mouth Study
- The trimming-line design of clear aligners (supragingival versus juxtagingival) is a routine clinical decision whose influence on patient-reported comfort has not been established; available evidence on aligner comfort derives almost exclusively from comparisons with fixed appliances.
- This observational, cross-sectional study compares two clear aligner trimming-line designs with respect to patient-reported comfort: a supragingival design, whose edge rests on the marginal gingiva, and a juxtagingival design, whose edge follows the gingival contour without covering it. Because the two designs sit differently against the gingival soft tissue, they may be experienced differently during wear.
- Participants are patients already wearing one trimming-line design on one dental arch and the other on the contralateral arch; each participant thus serves as their own control. After a minimum of four weeks of wear, participants complete a 20-item questionnaire once, rating the frequency of defined oral experiences for the maxillary and mandibular arch separately on a three-point ordinal scale (0 = none, 1 = occasional, 2 = frequent).
- The questionnaire is anonymous; the design worn on each arch is identified from which of two identical forms a participant completes. Responses for the two designs are compared within each participant. The study evaluates whether trimming-line design is associated with differences in patient-reported comfort.
연구 개요
상태
아직 모집하지 않음
상세 설명
- BACKGROUND AND RATIONALE
- Clear aligner therapy is an established modality in contemporary orthodontics. At the gingival margin, aligners are commonly trimmed according to one of two trimming-line designs, supragingival or juxtagingival. While the biomechanical and periodontal implications of trimming-line geometry have received attention, its influence on patient-reported outcomes remains uncharacterized. Available evidence on the comfort and oral health-related quality of life associated with aligner therapy derives predominantly from comparisons between aligners and fixed appliances, rather than from comparisons among aligner design parameters. The present study was designed to address this gap by evaluating whether trimming-line design is associated with differences in patient-reported comfort.
- THE TWO TRIMMING-LINE DESIGNS
- The supragingival design presents a straight marginal edge extending approximately 2 mm onto the marginal gingiva, in contact with the gingival surface without entering the gingival sulcus. The juxtagingival (festooned) design follows the scalloped contour of the gingival margin and terminates at the free gingival margin without overlying the gingiva. Both designs are fabricated from the same tri-layer thermoplastic aligner material (CA Pro, SCHEU-DENTAL GmbH, Iserlohn, Germany; CE-marked).
- STUDY DESIGN AND POPULATION
- This is an observational, cross-sectional, within-subject (split-mouth) study. Participants are patients in active clear aligner treatment who wear the two trimming-line designs, one per dental arch, prescribed as part of their orthodontic care. Each participant concurrently wears both designs and serves as their own control; the unit of comparison is the dental arch within the participant. Eligibility requires a minimum of four weeks of wear of the two designs. The planned enrollment is 70 participants.
- STUDY INSTRUMENT AND ADMINISTRATION
- The study instrument is a 20-item questionnaire developed for this study. The items address the functional and soft-tissue dimensions of aligner wear, including speech and phonation, mucosal and gingival sensation, retention and insertion, foreign-body sensation, and salivation and taste, corresponding to the oral surfaces in contact with the aligner margin. Each item is rated for frequency of occurrence during wear on a three-point ordinal scale (0 = none, 1 = occasional, 2 = frequent) and is answered separately for the maxillary and mandibular arch. The questionnaire is administered once, online, and is anonymous; no personal or identifying data are collected. Participants are aware that they are wearing two distinct trimming-line designs but are not informed which design corresponds to which arch, in order to limit response (expectation) bias.
- DESIGN ALLOCATION AND ANALYSIS
- The trimming-line design allocated to each arch varies among participants. Two identical questionnaire forms are employed: one is completed by participants in whom the maxillary arch carries the supragingival design (mandibular juxtagingival), and the other by participants with the reciprocal allocation. The form completed thereby encodes the arch-to-design correspondence without recourse to a participant identifier or any identifying data, preserving anonymity. Responses are classified by design accordingly, and supragingival and juxtagingival responses are compared within each participant. The primary analysis is an item-level comparison between designs using a paired non-parametric test (Wilcoxon signed-rank, two-sided, alpha = 0.05), supplemented by descriptive statistics (frequencies, means, standard deviations). A pre-specified secondary analysis compares the per-design total score (range 0 to 40), with assessment of internal consistency (Cronbach's alpha).
- RELATIONSHIP TO THE RESEARCH PROGRAM
- This study is the patient-experience component of a coordinated doctoral research program of four parallel split-mouth investigations of clear aligner trimming-line design (periodontal status, subgingival microbiota, optical stability, and patient-reported comfort); findings are interpreted alongside the companion studies at the group level.
연구 유형
관찰
등록 (추정된)
70
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: EMILIA (PRODEA) RUSU, DDS, Specialist Orthodontist
- 전화번호: +40756607316
- 이메일: rusu.emilia.24@stud.umfst.ro
연구 장소
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Sibiu County
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Sibiu, Sibiu County, 루마니아, 550027
- Aorys Clinic
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연락하다:
- EMILIA (PRODEA) RUSU, DDS, Specialist Orthodontist
- 전화번호: +40756607316
- 이메일: rusu.emilia.24@stud.umfst.ro
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
Adolescent and adult patients (aged 15 years or older) in active orthodontic treatment with clear aligners, including finishing (refinement) aligners, in whom a supragingival trimming-line design is worn on one dental arch and a juxtagingival design on the contralateral arch.
Eligible participants have worn the two designs for at least four weeks at the time the questionnaire is completed.
Recruitment is conducted at a single orthodontic practice.
설명
Inclusion Criteria:
- Adolescent or adult patient (aged 15 years or older)
- Active orthodontic treatment with clear aligners, including finishing (refinement) aligners
- Wearing two clear aligners with different trimming-line designs, one per dental arch: a supragingival design on one arch and a juxtagingival design on the contralateral arch
- At least 4 weeks of wear of the two designs at the time of questionnaire completion
- Good treatment compliance
- Willing and able to complete the online questionnaire and provide the required consent
Exclusion Criteria:
- Mixed orthodontic treatment (aligners combined with fixed appliances)
- Pre-existing neurological, cognitive, or speech disorders
- Systemic conditions affecting the oral cavity (e.g., xerostomia, mucosal disorders)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Group/Cohort (1): Split-mouth participants (both trimming-line designs)
Patients wearing the supragingival trimming-line design on one dental arch and the juxtagingival design on the contralateral arch, who completed the comfort questionnaire after at least four weeks of wear.
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Clear aligner edge covering approximately 2 mm of marginal gingiva (straight cut), worn on one dental arch.
Clear aligner edge following the scalloped gingival contour, terminating at the free gingival margin without covering the gingiva, worn on the contralateral arch.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Per-item patient-reported frequency (0-2) for the supragingival versus juxtagingival design
기간: Day 28 (+/- 2 days) after the start of wear of the two designs
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For each of the 20 questionnaire items (each rated 0 = no, 1 = occasionally, 2 = frequently, recorded separately for the two dental arches), the response associated with the supragingival design is compared with the response associated with the juxtagingival design within each participant, using a paired non-parametric test (Wilcoxon signed-rank, two-sided, alpha 0.05).
Responses are also summarized descriptively (frequencies, means, standard deviations).
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Day 28 (+/- 2 days) after the start of wear of the two designs
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total patient-reported discomfort score per design (0-40)
기간: Day 28 (+/- 2 days) after the start of wear of the two designs
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Pre-specified secondary analysis.
For each participant, the 20 item scores associated with each design are summed to a total from 0 (no reported discomfort) to 40 (maximum reported frequency across all items); the supragingival and juxtagingival totals are compared within participants (Wilcoxon signed-rank, two-sided, alpha 0.05).
Internal consistency of the total score is assessed (Cronbach's alpha).
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Day 28 (+/- 2 days) after the start of wear of the two designs
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: EMILIA (PRODEA) RUSU, George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania
- 연구 의자: LUMINITA LAZAR, DDS, PhD, George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.
- Zhang B, Huang X, Huo S, Zhang C, Zhao S, Cen X, Zhao Z. Effect of clear aligners on oral health-related quality of life: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):363-370. doi: 10.1111/ocr.12382. Epub 2020 May 13.
- 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.
- Tunca Y, Kaya Y, Tunca M, Keskin S. Comparison of anxiety, pain, and quality of life in individuals with mild or moderate malocclusion between conventional fixed orthodontic treatment versus Invisalign: a randomised clinical trial. BMC Oral Health. 2024 May 17;24(1):576. doi: 10.1186/s12903-024-04335-1.
- Alajmi S, Shaban A, Al-Azemi R. Comparison of Short-Term Oral Impacts Experienced by Patients Treated with Invisalign or Conventional Fixed Orthodontic Appliances. Med Princ Pract. 2020;29(4):382-388. doi: 10.1159/000505459. Epub 2019 Dec 17.
- Di Spirito F, D'Ambrosio F, Cannata D, D'Anto V, Giordano F, Martina S. Impact of Clear Aligners versus Fixed Appliances on Periodontal Status of Patients Undergoing Orthodontic Treatment: A Systematic Review of Systematic Reviews. Healthcare (Basel). 2023 May 6;11(9):1340. doi: 10.3390/healthcare11091340.
- Nakornnoi T, Srirodjanakul W, Chintavalakorn R, Santiwong P, Sipiyaruk K. The biomechanical effects of clear aligner trimline designs and extensions on orthodontic tooth movement: a systematic review. BMC Oral Health. 2024 Dec 20;24(1):1523. doi: 10.1186/s12903-024-05274-7.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 8월 1일
연구 완료 (추정된)
2026년 8월 1일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- COMFORT-ALIGN-ORTHO
- 3885/2025 (기타 식별자: Ethics Committee for Scientific Research, UMFST Targu Mures)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The study collects anonymous questionnaire responses, with no participant code or identifying data; the trimming-line design per arch is derived from which of two identical forms a participant completed.
A minimal de-identified dataset (per-design total discomfort scores) will be made available upon reasonable request to the corresponding author following publication.
Companion-study data are not linked.
IPD 공유 기간
Beginning 6 months after publication of primary study results.
IPD 공유 액세스 기준
Upon reasonable request to the corresponding author (PI); requests reviewed within 30 days.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .