Patient ComfortCOMFORT-ALIGNNCT07660809

Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study

An observational study of Patient Comfort and Malocclusion, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: Patient Comfort, Malocclusion, Oral Health
What is being tested?: Supragingival trimming-line design and Juxtagingival festooned trimming-line design
Type of treatment: Medical device
How many people: 70 participants
Where: 1 siteRomania
Study dates: 1 Jul 2026to 7 Aug 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Romania1 site

Aorys Clinic
Sibiu, Sibiu County, 550027

Other trials in Romania

About this study

Official title: 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.

Read the detailed description

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.

Conditions: Patient Comfort, Malocclusion, Oral Health
Being tested: Supragingival trimming-line design, Juxtagingival festooned trimming-line design
Keywords: clear aligners, trimming-line design, gingival margin, supragingival, juxtagingival, split-mouth design, patient-reported outcome, comfort, oral health-related quality of life, questionnaire, orthodontics, finishing orthodontic treatment
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supragingival trimming-line designDevice
Clear aligner edge covering approximately 2 mm of marginal gingiva (straight cut), worn on one dental arch.
Juxtagingival festooned trimming-line designDevice
Clear aligner edge following the scalloped gingival contour, terminating at the free gingival margin without covering the gingiva, worn on the contralateral arch.

Study groups in NCT07660809
Study group	Role	What they receive
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. Receives: Device: Supragingival trimming-line design; Device: Juxtagingival festooned trimming-line design

What is being measured

The primary outcome is the main question the study is designed to answer.

Per-item patient-reported frequency (0-2) for the supragingival versus juxtagingival design
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).
Measured: Day 28 (+/- 2 days) after the start of wear of the two designs

Secondary outcomes (1)

Total patient-reported discomfort score per design (0-40)
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).
Measured: Day 28 (+/- 2 days) after the start of wear of the two designs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20267 Aug 2026

First posted22 Jun 2026
Study start1 Jul 2026
Primary completion7 Aug 2026
Study completion7 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Patient ComfortStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07660809
Sponsor's protocol ID: COMFORT-ALIGN-ORTHO
Other IDs: 3885/2025
Acronym: COMFORT-ALIGN
Status last verified: Aug 2026
First submitted: 16 Jun 2026
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 38760747
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.
PubMed 35663697
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.
PubMed 32340082
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.
PubMed 31842018
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.
PubMed 37174882
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.
PubMed 36641738
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.
PubMed 39707339
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.
PubMed 41892738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Patient-Reported Comfort Between Supragingival and Juxtagingival Clear Aligner Trimming-Line Designs: A Cross-Sectional, Within-Subject Split-Mouth Study
ClinicalTrials.gov ID: NCT07660809
Acronym / sponsor ID: COMFORT-ALIGN / COMFORT-ALIGN-ORTHO
Conditions: Patient Comfort, Malocclusion, Oral Health
Keywords: clear aligners, trimming-line design, gingival margin, supragingival, juxtagingival, split-mouth design, patient-reported outcome, comfort
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresUniversity, hospital or other
Study start: 1 Jul 2026 (actual)
Primary completion: 7 Aug 2026 (actual)
Study completion: 7 Aug 2026 (actual)
First posted: 22 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Group/Cohort (1): Split-mouth participants (both trimming-line designs)	–	Device: Supragingival trimming-line design, Device: Juxtagingival festooned trimming-line designPatients 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.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supragingival trimming-line designClear aligner edge covering approximately 2 mm of marginal gingiva (straight cut), worn on one dental arch.	Device	Group/Cohort (1): Split-mouth participants (both trimming-line designs)
Juxtagingival festooned trimming-line designClear aligner edge following the scalloped gingival contour, terminating at the free gingival margin without covering the gingiva, worn on the contralateral arch.	Device	Group/Cohort (1): Split-mouth participants (both trimming-line designs)

Primary outcome

Per-item patient-reported frequency (0-2) for the supragingival versus juxtagingival design
Time frame: Day 28 (+/- 2 days) after the start of wear of the two designs
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).

1 secondary outcome

Total patient-reported discomfort score per design (0-40)
Time frame: Day 28 (+/- 2 days) after the start of wear of the two designs

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Background: PubMed 38760747Tunca 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.
Background: PubMed 35663697Jaber 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.
Background: PubMed 32340082Zhang 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.
Background: PubMed 31842018Alajmi 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.
Background: PubMed 37174882Di 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.
Background: PubMed 36641738Crego-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.
Background: PubMed 39707339Nakornnoi 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.
Background: PubMed 41892738Rusu 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

EMILIA (PRODEA) RUSU principal investigator

George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania

LUMINITA LAZAR, DDS, PhD study chair

George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Comfort and Malocclusion, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per-item patient-reported frequency (0-2) for the supragingival versus juxtagingival design (time frame: Day 28 (+/- 2 days) after the start of wear of the two designs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660809, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.