Clear Aligner TherapyNCT07522216
Effect of Clear Aligner Wear Protocol on External Root Resorption
A study testing Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols in people with Clear Aligner Therapy, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Clear Aligner Therapy
- What is being tested?
- Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteJordan
- Study dates
- 2 Feb 2025to 15 May 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with complete permanent dentition except wisdom teeth
- Participants presented with mild to moderate malocclusion (Average degree of crowding).
- Participants with good oral hygiene and absence of periodontal disease.
- No history of trauma or prior orthodontic treatment.
Who cannot join
- Participants with thin or petite roots.
- Participants with pre-existing root resorption
- Participants with endodontically treated incisors or canines.
- Participants with history of trauma to incisors teeth
- Participants with previous orthodontic treatment.
- Participants with periapical pathology, ankylosisor cystic lesions.
- Participants with medical conditions that may affecting pain or inflammatory responses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Clear Aligner Wear Protocol on External Root Resorption: A Randomized Controlled Clinical Trial
The aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception
Read the detailed description
Fifty adult patients (21 Male and 29 female with a mean age of 23.7 ± 1.8) presented at the postgraduate orthodontic clinics at Jordan University of Science and Technology (JUST) were randomly allocated into a 7-day or 14-day aligner change protocol. Each patient underwent a standardized series of digital periapical radiographs (three upper and three lower). Baseline radiographs (T0) were taken before the initiation of treatment, and follow-up radiographs (T1) were collected after six months of aligner therapy.
EARR was measured from a line drawn at the cemento-enamel junction (CEJ) to the tooth's apex before treatment (T₀), and after treatment (T1), the difference in length was calculated and graded using the Malmgren Index. Pain perception was assessed using a verbal rating scale (VRS) at six-time intervals (24 hours, first week, second week, first month, third month and sixth month). Statistical analyses were used to compare pre- and post-treatment changes within and between the groups. Multiple linear regression was used to identify predictors of EARR.
- Conditions
- Clear Aligner Therapy
- Being tested
- Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols
- Keywords
- Root resorption, Aligner wearing protocol
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocolsOther
One group should change the orthodontic clear aligner every week (7 days) and the second group every two weeks (14 days)
| Study group | Role | What they receive |
|---|---|---|
| 7-day aligner wearing protocol | Active comparator | Not described Receives: Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols |
| 14-day aligner wearing protocol | Active comparator | Not described Receives: Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root resorption
Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs
Measured: 6 months
Secondary outcomes (1)
Pain perception
Pain perception will be measured in the two groups
Measured: After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Feb 2025
- Primary completion1 Apr 2026
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Aligner TherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522216
- Sponsor's protocol ID
- JUST20240558
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clear Aligner Wear Protocol on External Root Resorption: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07522216
- Acronym / sponsor ID
- JUST20240558
- Conditions
- Clear Aligner Therapy
- Keywords
- Root resorption, Aligner wearing protocol
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 13 Apr 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 aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception
Detailed description
Fifty adult patients (21 Male and 29 female with a mean age of 23.7 ± 1.8) presented at the postgraduate orthodontic clinics at Jordan University of Science and Technology (JUST) were randomly allocated into a 7-day or 14-day aligner change protocol. Each patient underwent a standardized series of digital periapical radiographs (three upper and three lower). Baseline radiographs (T0) were taken before the initiation of treatment, and follow-up radiographs (T1) were collected after six months of aligner therapy.
EARR was measured from a line drawn at the cemento-enamel junction (CEJ) to the tooth's apex before treatment (T₀), and after treatment (T1), the difference in length was calculated and graded using the Malmgren Index. Pain perception was assessed using a verbal rating scale (VRS) at six-time intervals (24 hours, first week, second week, first month, third month and sixth month). Statistical analyses were used to compare pre- and post-treatment changes within and between the groups. Multiple linear regression was used to identify predictors of EARR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-day aligner wearing protocol | Active comparator | Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols |
| 14-day aligner wearing protocol | Active comparator | Other: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with complete permanent dentition except wisdom teeth
- Participants presented with mild to moderate malocclusion (Average degree of crowding).
- Participants with good oral hygiene and absence of periodontal disease.
- No history of trauma or prior orthodontic treatment.
Key exclusion criteria (7 listed)
- Participants with thin or petite roots.
- Participants with pre-existing root resorption
- Participants with endodontically treated incisors or canines.
- Participants with history of trauma to incisors teeth
- Participants with previous orthodontic treatment.
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 |
|---|---|---|
| Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocolsOne group should change the orthodontic clear aligner every week (7 days) and the second group every two weeks (14 days) | Other | 14-day aligner wearing protocol, 7-day aligner wearing protocol |
Primary outcome
Root resorption
Time frame: 6 months
Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs
1 secondary outcome
Pain perception
Time frame: After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months
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 13 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols in people with Clear Aligner Therapy, run by Jordan University of Science and Technology at 1 site in Jordan.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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 Jordan. 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?
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?
Root resorption (time frame: 6 months). 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 13 Apr 2026.