Orthodontic Pathological Resorption of External RootNCT06410105
Orthodontic Treatment With Clear Aligner
A study testing CLEAR ALIGNERS in people with Orthodontic Pathological Resorption of External Root, run by Latakia University at 1 site in Syria.
Trial summary
Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pathological Resorption of External Root
- What is being tested?
- CLEAR ALIGNERS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSyria
- Study dates
- 19 Dec 2020to 15 Mar 2024
- Phase
- Interventional
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The Clinical Diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification healthy patient No previous orthodontic treatment vital teeth with periodontal tissue without root absorption,
Who cannot join
- Previous history of orthodontic or orthopedic treatment. Presence of craniofacial anomalies. Presence of any signs and symptoms of gingival and periodontal diseases. Presence of significant medical history (including drug allergy). Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Assessment of Root Resorption Following Treatment With Clear Aligners Using Cone Beam Computed Tomography
Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.
Read the detailed description
Orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption.
There is a controversy in the literature regarding the effect of clear aligners on apical root resorption. One previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials Till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.
- Being tested
- CLEAR ALIGNERS
- Keywords
- Orthodontic, clear aligners, fixed appliances, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEAR ALIGNERSDevice
The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm
| Study group | Role | What they receive |
|---|---|---|
| Groub(1): 13 patient treated with CLEAR ALIGNERS | Experimental | The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm Receives: Device: CLEAR ALIGNERS |
| Groub(2): 13 patient treated with a fixed orthodontic | Experimental | . The FA group included 13 patients treated with a fxed orthodontic appliance (american orthodontics, WI.Sheboygam, USA). Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm, which Receives: Device: CLEAR ALIGNERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment with clear aligners
to determine the root resorption for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.)
Measured: two years
Secondary outcomes (1)
comparative study of Buccolingual Inclination changes
to evaluate the Buccolingual Inclination changes and for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start19 Dec 2020
- Primary completion20 Nov 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Pathological Resorption of External RootStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- : Crossover Assignment A randomized, controlled, crossover, double-blind clinical study, Comparison of
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fadi khalil, prof, Study chair, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410105
- Sponsor's protocol ID
- Tishreen U _orthodontic
- Status last verified
- Dec 2020
- First submitted
- 4 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol ,Informed Consent From
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Assessment of Root Resorption Following Treatment With Clear Aligners Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT06410105
- Acronym / sponsor ID
- Tishreen U _orthodontic
- Keywords
- Orthodontic, clear aligners, fixed appliances, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 May 2024 (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.
Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.
Detailed description
Orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption.
There is a controversy in the literature regarding the effect of clear aligners on apical root resorption. One previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials Till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- : Crossover Assignment A randomized, controlled, crossover, double-blind clinical study, Comparison of
| Arm | Type | Receives |
|---|---|---|
| Groub(1): 13 patient treated with CLEAR ALIGNERS | Experimental | Device: CLEAR ALIGNERSThe CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm |
| Groub(2): 13 patient treated with a fixed orthodontic | Experimental | Device: CLEAR ALIGNERS. The FA group included 13 patients treated with a fxed orthodontic appliance (american orthodontics, WI.Sheboygam, USA). Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm, which |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The Clinical Diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification healthy patient No previous orthodontic treatment vital teeth with periodontal tissue without root absorption,
Key exclusion criteria (1 listed)
- Previous history of orthodontic or orthopedic treatment. Presence of craniofacial anomalies. Presence of any signs and symptoms of gingival and periodontal diseases. Presence of significant medical history (including drug allergy). Pregnant and lactating women
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 |
|---|---|---|
| CLEAR ALIGNERSThe CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm | Device | Groub(1): 13 patient treated with CLEAR ALIGNERS, Groub(2): 13 patient treated with a fixed orthodontic |
Primary outcome
treatment with clear aligners
Time frame: two years
to determine the root resorption for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.)
1 secondary outcome
comparative study of Buccolingual Inclination changes
Time frame: two years
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 10 May 2024.
- Individual participant dataSharing planned: Yes. study protocol ,Informed Consent From
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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.
fadi khalil, prof study chair
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLEAR ALIGNERS in people with Orthodontic Pathological Resorption of External Root, run by Latakia University at 1 site in Syria.
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 1 inclusion and 1 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 10 May 2024. 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 Syria. 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?
treatment with clear aligners (time frame: two years). 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 10 May 2024.