Orthodontic Appliance ComplicationNCT06554769
Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
A study testing non rigid indirect anchorage connection and rigid indirect anchorage connection in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases Read more about this study
- Who is it for?
- Ages 13 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- non rigid indirect anchorage connection and rigid indirect anchorage connection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2023to 2 Jun 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 13 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene
Who cannot join
- History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication
Trial locations and contacts
1 site in 1 country.
About this study
Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases
Read the detailed description
Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured
- Conditions
- Orthodontic Appliance Complication
- Being tested
- non rigid indirect anchorage connection, rigid indirect anchorage connection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non rigid indirect anchorage connectionProcedure or surgery
a nonrigid connection is placed between the miniscrews and the second premolar to prevent mesial tooth movement.
rigid indirect anchorage connectionProcedure or surgery
a rigid connection is placed between the miniscrews and the first molar to prevent mesial tooth movement.
| Study group | Role | What they receive |
|---|---|---|
| Non-Rigid connection | Experimental | side received a non-rigid 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Receives: Procedure: non rigid indirect anchorage connection |
| Rigid Connection | Active comparator | rigid wire 19 x 25 inch stst wire was place between upper first molar and the miniscrew placed between the first molar and second premolar Receives: Procedure: rigid indirect anchorage connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
anchorage loss
amount of anchorage loss of the upper first molar during canine retraction using digital model in mm.
Measured: 4 month
Secondary outcomes (1)
vertical position of the upper second premolar
The secondary outcome was to assess the change in the vertical position of the upper second premolar following canine retraction using indirect anchorage using digital models in mm.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jul 2023
- Primary completion1 Feb 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- split mouth randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Timamy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554769
- Sponsor's protocol ID
- Cairo University (CairoU)
- Status last verified
- Aug 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study
- ClinicalTrials.gov ID
- NCT06554769
- Acronym / sponsor ID
- Cairo University (CairoU)
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 15 Aug 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.
Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases
Detailed description
Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Non-Rigid connection | Experimental | Procedure: non rigid indirect anchorage connectionside received a non-rigid 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. |
| Rigid Connection | Active comparator | Procedure: rigid indirect anchorage connectionrigid wire 19 x 25 inch stst wire was place between upper first molar and the miniscrew placed between the first molar and second premolar |
Who may qualify
- Ages
- 13 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene
Key exclusion criteria (1 listed)
- History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication
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 rigid indirect anchorage connectiona nonrigid connection is placed between the miniscrews and the second premolar to prevent mesial tooth movement. | Procedure or surgery | Non-Rigid connection |
| rigid indirect anchorage connectiona rigid connection is placed between the miniscrews and the first molar to prevent mesial tooth movement. | Procedure or surgery | Rigid Connection |
Primary outcome
anchorage loss
Time frame: 4 month
amount of anchorage loss of the upper first molar during canine retraction using digital model in mm.
1 secondary outcome
vertical position of the upper second premolar
Time frame: 4 month
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 Aug 2024.
Related trials for Orthodontic Appliance Complication
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Orthodontic Appliance, Pain
Not yet recruiting
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
Tooth Demineralization, White Spot Lesion
Recruiting
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Orthodontic Appliances, Removable, Orthodontic Appliance Complication
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 non rigid indirect anchorage connection and rigid indirect anchorage connection in people with Orthodontic Appliance Complication, run by Cairo 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 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 15 Aug 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 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?
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?
anchorage loss (time frame: 4 month). 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 15 Aug 2024.