Angle Class INCT06638983
Effectives of Non-extraction Orthodontic Treatment of Angle Class I Malocclusion
A study testing Non-extraction Orthodontic Treatment of Angle Class I Malocclusion in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Introduction: The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class I
- What is being tested?
- Non-extraction Orthodontic Treatment of Angle Class I Malocclusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteVietnam
- Study dates
- 20 May 2020to 15 Jun 2022
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients (≥ 15 years) with indicated Angle class I malocclusion and missing space ≤9mm
- Cervical vertebral maturation stages 5, 6, (CS5, CS6): cervical vertebrae 2, 3, and 4 have a concave curved lower border and have at least one rectangle C3, C4 cervical vertebra upright or at least square
- No prior orthodontic treatment
- Fully erupted permanent teeth (except third molars)
- Voluntary research participation
Who cannot join
- Face soft tissue surgical procedures, periodontal disease, and maxillofacial congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectives of Non-extraction Orthodontic Treatment of Angle Class I Malocclusion: A Non-randomized Pre-post Interventional Study
Introduction: The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
Read the detailed description
Many people are also concerned about their oral health. When social communication is more important, aesthetic concerns also receive a lot of attention. A beautiful smile can boost self-assurance and empathy. Angle class I malocclusion is prevalent, and dental malocclusion is a significant percentage of the population at all ages . Tooth extraction is a controversial topic in orthodontics, with the general view being against it. Angle and his students argued against it, but Charles Tweed saw recurrence in the 1930s after retreatment without extraction and retreatment with extraction. The use of tooth extraction therapy increased in the 1960s but has become less common since the late 20th century. The science of orthodontics has made significant advancements under the principle of least invasiveness, but the debate remains about whether to consider tooth extraction. The contemporary view believes that the majority of patients may and should be treated without tooth extraction, but in rare circumstances, extraction is necessary to make up for crowding and excessive incisor protrusion that harm the beauty. In truth, each individual must be thoroughly evaluated in light of their bite, cosmetic condition, and stability in the wake of therapy before any course of action is recommended. The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
- Conditions
- Angle Class I
- Being tested
- Non-extraction Orthodontic Treatment of Angle Class I Malocclusion
- Keywords
- Non-extraction, orthodontics treatment, Angle class I malocclusion
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-extraction Orthodontic Treatment of Angle Class I MalocclusionOther
Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention
| Study group | Role | What they receive |
|---|---|---|
| Cephalometric radiographs and cast impressions were collected before and after intervention. | Other | Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Receives: Other: Non-extraction Orthodontic Treatment of Angle Class I Malocclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
We aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment
Measured: Cephalometric radiographs, and extraoral and intraoral photographs, cast impressions and PAR Index (Peer Assessment Rating) were collected before and after intervention through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 May 2020
- Primary completion20 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angle Class IStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention, SNA, SNB, ANB, SN\_GoGn, SN\_Occplane, U1\_NAmm, U1\_NA, L1\_NBmm, L1\_NB, U1\_L1, U1\_Mp, Ls\_E, Li\_E, and Nasolabial\_angle. Intervention was MBT (MBT System, 3M Unitek, USA) non-extraction fixed orthodontic treatment. One experienced researcher analyzed and interpreted all of the cephalometric images used in the study using the WedCeph (https://webceph.com/). Data were analyzed by linear regression and T-Test statistical test using R software version 4.3.0 (R Foundation for Statistical Computing, Vienna, Austria) by a blinded statistician.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diem Chau Hong, DDS, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638983
- Sponsor's protocol ID
- ChauHongDiemCtump
- Status last verified
- May 2020
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baik KM, Anbar G, Alshaikh A, Banjar A. Effect of Social Media on Patient's Perception of Dental Aesthetics in Saudi Arabia. Int J Dent. 2022 Feb 27;2022:4794497. doi: 10.1155/2022/4794497. eCollection 2022.
PubMed 35265132
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectives of Non-extraction Orthodontic Treatment of Angle Class I Malocclusion: A Non-randomized Pre-post Interventional Study
- ClinicalTrials.gov ID
- NCT06638983
- Acronym / sponsor ID
- ChauHongDiemCtump
- Conditions
- Angle Class I
- Keywords
- Non-extraction, orthodontics treatment, Angle class I malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 15 Oct 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.
Introduction: The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
Detailed description
Many people are also concerned about their oral health. When social communication is more important, aesthetic concerns also receive a lot of attention. A beautiful smile can boost self-assurance and empathy. Angle class I malocclusion is prevalent, and dental malocclusion is a significant percentage of the population at all ages . Tooth extraction is a controversial topic in orthodontics, with the general view being against it. Angle and his students argued against it, but Charles Tweed saw recurrence in the 1930s after retreatment without extraction and retreatment with extraction. The use of tooth extraction therapy increased in the 1960s but has become less common since the late 20th century. The science of orthodontics has made significant advancements under the principle of least invasiveness, but the debate remains about whether to consider tooth extraction. The contemporary view believes that the majority of patients may and should be treated without tooth extraction, but in rare circumstances, extraction is necessary to make up for crowding and excessive incisor protrusion that harm the beauty. In truth, each individual must be thoroughly evaluated in light of their bite, cosmetic condition, and stability in the wake of therapy before any course of action is recommended. The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention, SNA, SNB, ANB, SN_GoGn, SN_Occplane, U1_NAmm, U1_NA, L1_NBmm, L1_NB, U1_L1, U1_Mp, Ls_E, Li_E, and Nasolabial_angle. Intervention was MBT (MBT System, 3M Unitek, USA) non-extraction fixed orthodontic treatment. One experienced researcher analyzed and interpreted all of the cephalometric images used in the study using the WedCeph (https://webceph.com/). Data were analyzed by linear regression and T-Test statistical test using R software version 4.3.0 (R Foundation for Statistical Computing, Vienna, Austria) by a blinded statistician.
| Arm | Type | Receives |
|---|---|---|
| Cephalometric radiographs and cast impressions were collected before and after intervention. | Other | Other: Non-extraction Orthodontic Treatment of Angle Class I MalocclusionCephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients (≥ 15 years) with indicated Angle class I malocclusion and missing space ≤9mm
- Cervical vertebral maturation stages 5, 6, (CS5, CS6): cervical vertebrae 2, 3, and 4 have a concave curved lower border and have at least one rectangle C3, C4 cervical vertebra upright or at least square
- No prior orthodontic treatment
- Fully erupted permanent teeth (except third molars)
- Voluntary research participation
Key exclusion criteria (1 listed)
- Face soft tissue surgical procedures, periodontal disease, and maxillofacial congenital anomalies
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 |
|---|---|---|
| Non-extraction Orthodontic Treatment of Angle Class I MalocclusionCephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention | Other | Cephalometric radiographs and cast impressions were collected before and after intervention. |
Primary outcome
We aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.
Time frame: Cephalometric radiographs, and extraoral and intraoral photographs, cast impressions and PAR Index (Peer Assessment Rating) were collected before and after intervention through study completion, an average of 2 years
Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment
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 15 Oct 2024.
- Results publication: PubMed 35265132Baik KM, Anbar G, Alshaikh A, Banjar A. Effect of Social Media on Patient's Perception of Dental Aesthetics in Saudi Arabia. Int J Dent. 2022 Feb 27;2022:4794497. doi: 10.1155/2022/4794497. eCollection 2022.
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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.
Diem Chau Hong, DDS principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-extraction Orthodontic Treatment of Angle Class I Malocclusion in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 5 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 15 Oct 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 Vietnam. 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?
We aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion. (time frame: Cephalometric radiographs, and extraoral and intraoral photographs, cast impressions and PAR Index (Peer Assessment Rating) were collected before and after intervention through study completion, an average of 2 years). 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 NCT06638983, which also lists 1 linked publication.
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 15 Oct 2024.