Accelerate Tooth MovementNCT03180151
The Effect of Corticotomy in En-mass Retraction
A study testing piezotome assisted orthodontic tooth movement in people with Accelerate Tooth Movement, run by King Abdulaziz University.
Trial summary
To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome. Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Accelerate Tooth Movement
- What is being tested?
- piezotome assisted orthodontic tooth movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2018
- 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
- Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
- Healthy systemic conditions.
- No previous orthodontic treatment.
- Patient needs to be in permanent dentition (hence, we need to define their age range).
Who cannot join
- Patient with systemic disease.
- Patient having any signs of active periodontal disease.
- Patients on long-term corticosteroid therapy.
- Persons taking medications that slows down bone metabolism.
- Craniofacial anomalies.
About this study
- To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
- Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
- Monitor postoperative pain.
- Conditions
- Accelerate Tooth Movement
- Being tested
- piezotome assisted orthodontic tooth movement
- Keywords
- corticotomy, enmass retraction, mini implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezotome assisted orthodontic tooth movementProcedure or surgery
Also called corticotomy assisted tooth movement
Surgical procedure
- After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15.
- The incisions will be kept minimal.
- The incisions go though the periosteum, which permit the blade to reach to the alveolar bone.
- A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm.
- As we will not use bone graft so we don't need use suturing after cortication.
- We give patient antibiotic and analgesic cover.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic tooth movement group | No intervention | This is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome |
| Corticotomy assisted orthodontic group | Experimental | This is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement) Receives: Procedure: piezotome assisted orthodontic tooth movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of tooth movement per time
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
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 Accelerate Tooth MovementStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Habiballah Hassan, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180151
- Sponsor's protocol ID
- 078-16
- Status last verified
- Oct 2023
- First submitted
- 25 Dec 2016
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication, data can be shared with others upon request via email to the corresponding author.
Publications
Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.
PubMed 33435897
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Corticotomy in En-mass Retraction
- ClinicalTrials.gov ID
- NCT03180151
- Acronym / sponsor ID
- 078-16
- Conditions
- Accelerate Tooth Movement
- Keywords
- corticotomy, enmass retraction, mini implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jun 2017 (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.
- To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
- Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
- Monitor postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic tooth movement group | No intervention | –This is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome |
| Corticotomy assisted orthodontic group | Experimental | Procedure: piezotome assisted orthodontic tooth movementThis is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement) |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
- Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
- Healthy systemic conditions.
- No previous orthodontic treatment.
- Patient needs to be in permanent dentition (hence, we need to define their age range).
Key exclusion criteria (5 listed)
- Patient with systemic disease.
- Patient having any signs of active periodontal disease.
- Patients on long-term corticosteroid therapy.
- Persons taking medications that slows down bone metabolism.
- Craniofacial 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 |
|---|---|---|
| piezotome assisted orthodontic tooth movementAlso: corticotomy assisted tooth movementSurgical procedure 1. After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15. 2. The incisions will be kept minimal. 3. The incisions go though the periosteum, which permit the blade to reach to the alveolar bone. 4. A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm. 5. As we will not use bone graft so we don't need use suturing after cortication. 6. We give patient antibiotic and analgesic cover. | Procedure or surgery | Corticotomy assisted orthodontic group |
Primary outcome
rate of tooth movement per time
Time frame: 4 months
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 3 Oct 2023.
- Derived from this study: PubMed 33435897Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.
- Individual participant dataSharing planned: Undecided. After publication, data can be shared with others upon request via email to the corresponding author.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing piezotome assisted orthodontic tooth movement in people with Accelerate Tooth Movement, run by King Abdulaziz University.
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 5 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 tooth movement per time (time frame: 4 months). 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 NCT03180151, 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 3 Oct 2023.