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Intraoral Aging of 3D Printed Orthodontic Aligners

2026년 11월 5일 업데이트: Azza Gamal Kamel Wafa, Alexandria University

The Effect of Intraoral Aging on 3D-Printed Aligners: A Randomized Split-Mouth Study

This study aims to bridge the gap in literature by conducting a combined evaluation of the mechanical, chemical, optical, and morphological changes of 3D-printed clear aligners manufactured from TC-85 and TA-28 resins that occur after clinical use. By analyzing aligners retrieved after two weeks of intraoral use, this research will offer critical insights into the material stability and aging behavior of the two types of 3D-printed clear aligners.

연구 개요

상세 설명

Background: Direct 3D-printing of clear aligners is emerging as a promising alternative to conventional thermoformed systems, offering enhanced precision, digital workflow efficiency, and improved material control. Among the photopolymer resins used for 3D-printed aligners, Tera Harz TC-85 and Tera Harz TA-28 have emerged as leading materials due to their reported shape-memory behavior, dimensional stability, and mechanical performance. However, despite increasing clinical adoption, limited evidence exists regarding how these two materials respond to intraoral aging, where fluctuating pH, temperature changes, salivary enzymes, and occlusal forces may alter their mechanical, optical, chemical, and surface characteristics. Understanding these changes is essential for determining the clinical reliability and long-term performance of each resin.Therefore, a demanding evaluation of post-aging changes in 3D-printed aligners is essential to determine their suitability for sustained orthodontic force delivery and to guide material selection in clinical practice. Assessing how key properties such as mechanical behavior, dimensional accuracy, surface topography, and optical characteristics evolve after intraoral exposure will provide valuable insight into material durability and clinical reliability.

연구 유형

중재적

등록 (실제)

12

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, 이집트, 21526
        • Department of Orthodontics, Faculty of Dentistry, Alexandria University

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

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients aged 18-35 years.
  • Mild to moderate crowding.
  • Good oral hygiene and healthy periodontium.
  • Permanent dentition with no active caries.

Exclusion Criteria:

  • Patients with systemic diseases affecting saliva or oral mucosa.
  • Smoking or alcohol consumption.
  • History of parafunctional habits.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TC-85 maxillary / TA-28 mandibular

Participants received a directly 3D-printed TC-85 aligner in the maxillary arch and a directly 3D-printed TA-28 aligner in the mandibular arch. Both aligners were worn simultaneously for 2 weeks (22 hours/day).

Aligner directly 3D-printed from Tera Harz TC-85 shape-memory resin [add printer, layer thickness and post-curing protocol]. Worn 22 hours/day for 2 weeks in the maxillary or mandibular arch, according to a computer-generated randomization sequence.

실험적: TA-28 maxillary / TC-85 mandibular

Participants received a directly 3D-printed TA-28 aligner in the maxillary arch and a directly 3D-printed TC-85 aligner in the mandibular arch. Both aligners were worn simultaneously for 2 weeks (22 hours/day).

Aligner directly 3D-printed from Tera Harz TA-28 shape-memory resin [same printer, layer thickness and post-curing protocol as above]. Worn 22 hours/day for 2 weeks in the maxillary or mandibular arch, according to a computer-generated randomization sequence.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in indentation hardness (HIT), measured by instrumented nanoindentation
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Indentation hardness (HIT, GPa) of directly 3D-printed TC-85 and TA-28 aligners, measured by instrumented nanoindentation using a Nano Indenter XP (MTS Systems Corporation, USA) with a Berkovich diamond indenter. Tests were displacement-controlled to a maximum depth of 2000 nm at a constant strain rate of 0.05 s-¹, with 25 indentations per specimen spaced 30 μm apart. Testing followed ISO 14577-1:2015 and data were analyzed by the Oliver and Pharr method. Retrieved aligners are compared with unused aligners printed from the same digital design.

Baseline (unused aligner) and after 2 weeks of intraoral use

2차 결과 측정

결과 측정
측정값 설명
기간
Change in indentation elastic modulus (EIT), measured by instrumented nanoindentation
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Indentation elastic modulus (EIT, GPa) of directly 3D-printed TC-85 and TA-28 aligners, measured by instrumented nanoindentation using a Nano Indenter XP (MTS Systems Corporation, USA) with a Berkovich diamond indenter. Tests were displacement-controlled to a maximum depth of 2000 nm at a constant strain rate of 0.05 s-¹, with 25 indentations per specimen spaced 30 μm apart. A Poisson's ratio of 0.4 was assumed. Testing followed ISO 14577-1:2015 and data were analyzed by the Oliver and Pharr method. Retrieved aligners are compared with unused aligners printed from the same digital design.

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in color (ΔE₀₀, CIEDE2000), measured by UV-visible spectrophotometry
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Color of directly 3D-printed TC-85 and TA-28 aligners measured with a UV-visible spectrophotometer (V-770, JASCO Corporation, Tokyo, Japan). Each aligner was sectioned along the right central incisor-canine region, and the labial surface was positioned in a standardized manner facing the incident-light window. CIE Lab* coordinates were recorded according to ISO 11664-4:2019, and the color change between unused and retrieved aligners was calculated as ΔE₀₀ using the CIEDE2000 equation (parametric factors set to 1). Values are interpreted against 0.8 (50:50% perceptibility) and 1.8 (50:50% acceptability).

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in light transmittance and absorbance (400-700 nm), measured by UV-visible spectrophotometry
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Light transmittance and absorbance of TC-85 and TA-28 aligners recorded across the visible range (400-700 nm) with a UV-visible spectrophotometer (V-770, JASCO Corporation, Tokyo, Japan) using Spectra Manager II software, after calibration according to the manufacturer's instructions. Values at 400 and 700 nm were extracted from each spectrum and compared between materials and between unused and retrieved aligners.

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in aligner thickness (μm), measured by confocal laser scanning microscopy
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Thickness of TC-85 and TA-28 aligners measured by confocal laser scanning microscopy (Leica DMi8, Leica Microsystems, Wetzlar, Germany) with a 10× objective and 1.5× digital zoom under standardized imaging conditions. Standardized 4 × 4 mm specimens were taken from the labial surface of the left central incisor region. Z-stack images were reconstructed in 3D using Leica LAS AF software (version 1.1.0.12420), and thickness was calculated as the perpendicular distance between the upper and lower specimen surfaces. Each specimen was measured twice and the mean was used.

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in surface roughness (Sa, Sq, Sp, Sv), measured by confocal laser scanning microscopy
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Surface roughness of the inner surface of directly 3D-printed TC-85 and TA-28 aligners, assessed on the same 4 × 4 mm specimens used for thickness measurement, imaged by confocal laser scanning microscopy (Leica DMi8, Leica Microsystems, Wetzlar, Germany). Height maps generated from the z-stacks with Leica LAS AF software were analyzed in ImageJ (National Institutes of Health, USA) with the SurfCharJ-1q plugin to calculate Sa (arithmetical mean height), Sq (root mean square height), Sp (maximum peak height) and Sv (maximum valley depth), in µm. Analysis was repeated twice per specimen and the mean was used. Identical acquisition and analysis settings were applied to all specimens.

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in degree of conversion (DC), measured by ATR-FTIR spectroscopy
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Degree of conversion (%) of TC-85 and TA-28 aligners, calculated from attenuated total reflectance Fourier-transform infrared (ATR-FTIR) spectra as the reduction of the aliphatic C=C band near 1638 cm-¹ relative to, referenced to the corresponding unset resin. Retrieved aligners are compared with unused aligners.

Baseline (unused aligner) and after 2 weeks of intraoral use
Change in chemical structure, assessed by ATR-FTIR spectral analysis
기간: Baseline (unused aligner) and after 2 weeks of intraoral use

Qualitative comparison of ATR-FTIR spectra of unused and retrieved TC-85 and TA-28 aligners, focusing on the O-H/N-H stretching bands (3400-3200 cm-¹), aliphatic C-H bands (about 2920 and 2850 cm-¹), the carbonyl (C=O) band (about 1700 cm-¹) and the C-O/C-O-C region (1200-1000 cm-¹).

Baseline (unused aligner) and after 2 weeks of intraoral use

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Azza Gamal Wafa, PHD, Alexandria University

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 (실제)

2026년 2월 1일

기본 완료 (실제)

2026년 4월 1일

연구 완료 (실제)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 10월 31일

QC 기준을 충족하는 최초 제출

2026년 11월 5일

처음 게시됨 (실제)

2026년 11월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 1월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Individual participant data will not be shared publicly because of participant confidentiality and privacy considerations. The study involves a relatively small sample, and sharing individual-level data may pose a risk of participant identification. De-identified aggregate results will be reported in the published manuscripts. Data may be made available from the corresponding author upon reasonable request, subject to institutional ethical approval and applicable data-protection requirements.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

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