Canine RetractionNCT05872048
Evaluation of Periodontal Distractor in Acceleration of Canine Retraction
A study testing periodontal distractor in people with Canine Retraction, run by Al-Azhar University at 1 site in Egypt.
Trial summary
evaluate the effect of periodontal distractor with and without interseptal bone cuts on the displacement of the maxillary canines, to assess the effect of two approaches on the pain intensity and on the pulp vitality of the retracted canines. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Canine Retraction
- What is being tested?
- periodontal distractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 30 Jan 2023
- 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 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient age: 16-21 years.
- patients required bilateral extraction of maxillary first premolars followed by maxillary canine retraction (class I malocclusion as excessive overjet, bimaxillary protrusion, class II malocclusion).
- The dentition didn't exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
- No systemic disease that may affects the bone.
- No periodontal disease.
- Good oral hygiene.
- Very good patient compliance.
- Absence of any previous orthodontic treatment.
Who cannot join
- The dentition exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
- Cases with deep carious lesions or endodontic lesions involving the maxillary canines and buccal segments.
- Cases with severly rotated or grossly malpositioned canines.
- Systemic disease that may affects the bone.
- Periodontal disease and poor oral hygiene.
- Presence of previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Orthodontic Canine Retraction Via Two Approaches of Periodontal Distraction: A Comparative Clinical Study
evaluate the effect of periodontal distractor with and without interseptal bone cuts on the displacement of the maxillary canines, to assess the effect of two approaches on the pain intensity and on the pulp vitality of the retracted canines.
Read the detailed description
The sample of the study consisted of 32 canines in 16 female patients (16- 21 years old) requiring extraction of bilateral maxillary first premolars and canine retraction. They were divided into two groups: canine retraction was done by buccal periodontal distractor with distal interseptal bone cuts (Group I), canine retraction was done by buccal periodontal distractor without distal interseptal bone cuts (Group II). After bilateral maxillary premolar extraction in both groups inter septal bone cuts was done in group I only. Then the periodontal distractor was cemented and activated twice per day in both groups. Rate of canine retraction was evaluated before and after complete canine retraction direct in patient's mouth with digital caliper. Pain intensity was evaluated at 1st ,2nd ,4th and 7th days after activation through visual analog scale (VAS). An electrical vitality test was evaluated before and after the distraction procedure.
- Conditions
- Canine Retraction
- Being tested
- periodontal distractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal distractorDevice
custom made device from hyrex screw
| Study group | Role | What they receive |
|---|---|---|
| periodontal distractor with interseptal bone cuts | Experimental | Not described Receives: Device: periodontal distractor |
| periodontal distractor without interseptal bone cuts | Experimental | Not described Receives: Device: periodontal distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of canine retraction
amount of distalization\time
Measured: one month
Secondary outcomes (1)
pain intensity
visual analog scale minimum score = 0 maximum score = 10 higher scores mean worse outcome
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2022
- Primary completion5 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Canine RetractionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Mohamed El-Hendawey, Al-Azhar University
- Investigators
- Maha M Mohamed, assistant professor, Study director, Assistant professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, CairoFarouk A Hussein, Professor, Study chair, professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, CairoSuzan A Hssan, professor, Study chair, professor of oral sugery, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872048
- Sponsor's protocol ID
- distraction in orthodontics
- Status last verified
- May 2023
- First submitted
- 7 Mar 2023
- Last updated
- 24 May 2023
- 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Orthodontic Canine Retraction Via Two Approaches of Periodontal Distraction: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT05872048
- Acronym / sponsor ID
- distraction in orthodontics
- Conditions
- Canine Retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 24 May 2023 (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.
evaluate the effect of periodontal distractor with and without interseptal bone cuts on the displacement of the maxillary canines, to assess the effect of two approaches on the pain intensity and on the pulp vitality of the retracted canines.
Detailed description
The sample of the study consisted of 32 canines in 16 female patients (16- 21 years old) requiring extraction of bilateral maxillary first premolars and canine retraction. They were divided into two groups: canine retraction was done by buccal periodontal distractor with distal interseptal bone cuts (Group I), canine retraction was done by buccal periodontal distractor without distal interseptal bone cuts (Group II). After bilateral maxillary premolar extraction in both groups inter septal bone cuts was done in group I only. Then the periodontal distractor was cemented and activated twice per day in both groups. Rate of canine retraction was evaluated before and after complete canine retraction direct in patient's mouth with digital caliper. Pain intensity was evaluated at 1st ,2nd ,4th and 7th days after activation through visual analog scale (VAS). An electrical vitality test was evaluated before and after the distraction procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periodontal distractor with interseptal bone cuts | Experimental | Device: periodontal distractor |
| periodontal distractor without interseptal bone cuts | Experimental | Device: periodontal distractor |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patient age: 16-21 years.
- patients required bilateral extraction of maxillary first premolars followed by maxillary canine retraction (class I malocclusion as excessive overjet, bimaxillary protrusion, class II malocclusion).
- The dentition didn't exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
- No systemic disease that may affects the bone.
- No periodontal disease.
Key exclusion criteria (6 listed)
- The dentition exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
- Cases with deep carious lesions or endodontic lesions involving the maxillary canines and buccal segments.
- Cases with severly rotated or grossly malpositioned canines.
- Systemic disease that may affects the bone.
- Periodontal disease and poor oral hygiene.
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 |
|---|---|---|
| periodontal distractorcustom made device from hyrex screw | Device | periodontal distractor with interseptal bone cuts, periodontal distractor without interseptal bone cuts |
Primary outcome
rate of canine retraction
Time frame: one month
amount of distalization\time
1 secondary outcome
pain intensity
Time frame: one 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 24 May 2023.
Related trials for Canine Retraction
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Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
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Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Recruiting
Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
Accelerate Tooth Movement
Enrolling by invitation
Comparison of Maxillary Canine Retraction Rate With and Without Power Arm
Orthodontic Anchorage, Power Arm Sliding
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.
Maha M Mohamed, assistant professor study director
Assistant professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
Farouk A Hussein, Professor study chair
professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
Suzan A Hssan, professor study chair
professor of oral sugery, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal distractor in people with Canine Retraction, run by Al-Azhar 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 8 inclusion and 6 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 24 May 2023. 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?
rate of canine retraction (time frame: one 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 24 May 2023.