Bone MetabolismNCT07617571
Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners
A study testing Directly printed aligners using Tera Harz TA28 resin and PETG thermoplastic sheets in people with Bone Metabolism and Orthodontic Aligners, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Orthodontic forces induce tissue reactions by triggering perturbations from orthodontic appliances, which lead to the modelling and remodelling of alveolar bone. Despite the growing popularity of 3D-printed aligners, no studies have compared their effects on bone metabolism in comparison with thermoformed… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Bone Metabolism, Orthodontic Aligners
- What is being tested?
- Directly printed aligners using Tera Harz TA28 resin and PETG thermoplastic sheets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Minor malocclusion (2 to 4 mm of crowding) .
- Patients in need for Antero-posterior expansion and labial tipping of incisors without interproximal reduction
- No use of anti-inflammatory drugs or antibiotics in the past 6 months.
- Periodontal parameters of gingival index <1 and no pocketing with a generalized pocketing depth of <3mm.
- Radiographic parameters of no crestal bone loss.
- No history of smoking.
Who cannot join
- Signs of inflammation of the gingiva, and periodontitis.
- Systemic conditions (kidney disease, HIV, and liver disease).
- Teeth missing or poor oral hygiene.
- Bone disease e.g.; osteoporosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria
Ahmed Karkoura, BDS
Ahmed Karkoura, BDS
About this study
Official title: Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners (Randomized Controlled Clinical Trial)
Background: Orthodontic forces induce tissue reactions by triggering perturbations from orthodontic appliances, which lead to the modelling and remodelling of alveolar bone. Despite the growing popularity of 3D-printed aligners, no studies have compared their effects on bone metabolism in comparison with thermoformed aligners. Aim: This study aims to assess bone metabolism in patients undergoing treatment with 3D-printed aligners versus thermoformed aligners.
- Conditions
- Bone Metabolism, Orthodontic Aligners
- Being tested
- Directly printed aligners using Tera Harz TA28 resin, PETG thermoplastic sheets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly printed aligners using Tera Harz TA28 resinOther
Aligners will be digitally designed using the latest version of ArchForm software for segmentation of dental arches, virtual tooth movement planning and generation of sequential treatment stages, the finalized setups will be exported as STL files.
PETG thermoplastic sheetsOther
Aligners were digitally designed using the latest version of ArchForm software .The 3D-printed resin models which were used as a mold for aligner thermoforming, were fabricated by Anycubic Photon Mono M5s (12K resolution) (Anycubic, China) 3D printing machine.
| Study group | Role | What they receive |
|---|---|---|
| directly printed aligners | Experimental | Not described Receives: Other: Directly printed aligners using Tera Harz TA28 resin |
| thermoformed aligners | Active comparator | Not described Receives: Other: PETG thermoplastic sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in levels of Osteoprotegerin (OPG)
The frozen samples of GCF from participants with both types of aligners will be thawed at room temperature for enzyme-linked immunosorbent assay (ELISA).
Measured: up to 21 days
Secondary outcomes (3)
change in gingival inflammation
A measure used to assess the severity of gingival inflammation based on color, consistency, and bleeding of the gingiva. Scores range from healthy gingiva (score 0) to severe inflammation (Score 3)
Measured: up to 21 days
change in plaque accumulation
A clinical index used to assess the amount of dental plaque accumulated on tooth surfaces. It helps evaluate oral hygiene status by scoring plaque from (score 0) no plaque to heavy plaque accumulation (score 3)
Measured: up to 21 days
change in bleeding on probing
A clinical sign of gingival inflammation detected when gentle probing of the gingival sulcus causes bleeding. it is yes/no variable
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetabolismStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617571
- Sponsor's protocol ID
- 1070-05/2025
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07617571
- Acronym / sponsor ID
- 1070-05/2025
- Conditions
- Bone Metabolism, Orthodontic Aligners
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 1 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.
Background: Orthodontic forces induce tissue reactions by triggering perturbations from orthodontic appliances, which lead to the modelling and remodelling of alveolar bone. Despite the growing popularity of 3D-printed aligners, no studies have compared their effects on bone metabolism in comparison with thermoformed aligners. Aim: This study aims to assess bone metabolism in patients undergoing treatment with 3D-printed aligners versus thermoformed aligners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| directly printed aligners | Experimental | Other: Directly printed aligners using Tera Harz TA28 resin |
| thermoformed aligners | Active comparator | Other: PETG thermoplastic sheets |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Minor malocclusion (2 to 4 mm of crowding) .
- Patients in need for Antero-posterior expansion and labial tipping of incisors without interproximal reduction
- No use of anti-inflammatory drugs or antibiotics in the past 6 months.
- Periodontal parameters of gingival index <1 and no pocketing with a generalized pocketing depth of <3mm.
- Radiographic parameters of no crestal bone loss.
Key exclusion criteria (4 listed)
- Signs of inflammation of the gingiva, and periodontitis.
- Systemic conditions (kidney disease, HIV, and liver disease).
- Teeth missing or poor oral hygiene.
- Bone disease e.g.; osteoporosis.
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 |
|---|---|---|
| Directly printed aligners using Tera Harz TA28 resinAligners will be digitally designed using the latest version of ArchForm software for segmentation of dental arches, virtual tooth movement planning and generation of sequential treatment stages, the finalized setups will be exported as STL files. | Other | directly printed aligners |
| PETG thermoplastic sheetsAligners were digitally designed using the latest version of ArchForm software .The 3D-printed resin models which were used as a mold for aligner thermoforming, were fabricated by Anycubic Photon Mono M5s (12K resolution) (Anycubic, China) 3D printing machine. | Other | thermoformed aligners |
Primary outcome
change in levels of Osteoprotegerin (OPG)
Time frame: up to 21 days
The frozen samples of GCF from participants with both types of aligners will be thawed at room temperature for enzyme-linked immunosorbent assay (ELISA).
3 secondary outcomes
change in gingival inflammation
Time frame: up to 21 days
change in plaque accumulation
Time frame: up to 21 days
change in bleeding on probing
Time frame: up to 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly printed aligners using Tera Harz TA28 resin and PETG thermoplastic sheets in people with Bone Metabolism and Orthodontic Aligners, run by Alexandria University at 1 site in Egypt.
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 4 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: opening soon, as of the sponsor's last update on 1 Jun 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Karkoura, BDS (01110309060 ext. 002, ahmed.abdalrahman.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in levels of Osteoprotegerin (OPG) (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.