Class II Division 1 MalocclusionNCT03764189
Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
A study testing microosteoperforation in people with Class II Division 1 Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- microosteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2019to Nov 2020
- 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 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females with an age ranging between 16-30 years.
- Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
- Healthy dental and periodontal condition with a good oral hygiene
- Absence of degenerative conditions.
- Full set of permanent dentition.
Who cannot join
- Medically compromised patients.
- Previous orthodontic treatment
- Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
- Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
- Active periodontal affection or severe gingival inflammation.
Trial locations and contacts
1 site in 1 country.
Eman m el sayed, Phd contact
Egypt1 site
Cairo University
Cairo, Giza Governorate, 12566
Nashwa abdel m mohamed, 1020271313
About this study
Official title: Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial
accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.
Read the detailed description
the study contains 2 groups each contains 13 subjects, A control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- microosteoperforation
- Keywords
- Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microosteoperforationProcedure or surgery
Also called accelerated tooth movement, alveocentesis
small holes made using large round bur
| Study group | Role | What they receive |
|---|---|---|
| en masse retraction only | No intervention | anterior segment retraction on miniscrews without microosteoperforation |
| en masse retraction with alveocentesis | Active comparator | anterior segment retraction on miniscrews with microosteoperforation Receives: Procedure: microosteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of En-masse retraction
retracting six anterior teeth
Measured: three to six months
Secondary outcomes (3)
Root resorption affecting the six anterior teeth.
Amount of root volume loss analyzed through CBCT software
Measured: three to six months
Tipping affecting the anterior teeth.
Changes in angular measurements calculated through CBCT software
Measured: three to six months
Extrusion of anterior teeth
Linear measurement changes in the clinical height using CBCT
Measured: three to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies 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
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa abdel mohsen mohamed, Cairo University
- Investigators
- Mohamed A Kaddah, Phd, Study director, Cairo u
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764189
- Sponsor's protocol ID
- CEBD-CU-2018-11-41
- Status last verified
- Dec 2018
- First submitted
- 1 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.
Publications
McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.
PubMed 22284287Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.
PubMed 3177281Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21
Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
PubMed 15334614Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.
PubMed 29454369Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier
Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PubMed 24182579Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
PubMed 27275623Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
PubMed 24326198
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03764189
- Acronym / sponsor ID
- CEBD-CU-2018-11-41
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 5 Dec 2018 (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.
accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.
Detailed description
the study contains 2 groups each contains 13 subjects, A control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| en masse retraction only | No intervention | –anterior segment retraction on miniscrews without microosteoperforation |
| en masse retraction with alveocentesis | Active comparator | Procedure: microosteoperforationanterior segment retraction on miniscrews with microosteoperforation |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Females with an age ranging between 16-30 years.
- Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
- Healthy dental and periodontal condition with a good oral hygiene
- Absence of degenerative conditions.
- Full set of permanent dentition.
Key exclusion criteria (5 listed)
- Medically compromised patients.
- Previous orthodontic treatment
- Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
- Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
- Active periodontal affection or severe gingival inflammation.
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 |
|---|---|---|
| microosteoperforationAlso: accelerated tooth movement, alveocentesissmall holes made using large round bur | Procedure or surgery | en masse retraction with alveocentesis |
Primary outcome
Rate of En-masse retraction
Time frame: three to six months
retracting six anterior teeth
3 secondary outcomes
Root resorption affecting the six anterior teeth.
Time frame: three to six months
Tipping affecting the anterior teeth.
Time frame: three to six months
Extrusion of anterior teeth
Time frame: three to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Background: PubMed 22284287McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.
- BackgroundNicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
- Background: PubMed 3177281Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.
- BackgroundBlanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21
- Background: PubMed 15334614Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
- Background: PubMed 29454369Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.
- BackgroundAlikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier
- Background: PubMed 24182579Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
- Background: PubMed 27275623Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
- Results publication: PubMed 24326198Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
- Individual participant dataSharing planned: No. All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.
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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.
Eman m el sayed, Phd contact
Mohamed A Kaddah, Phd study director
Cairo u
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microosteoperforation in people with Class II Division 1 Malocclusion, 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 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: status not confirmed, as of the sponsor's last update on 7 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nashwa abdel m mohamed, master (01020271313, dr.nashwa_87@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of En-masse retraction (time frame: three to six 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 NCT03764189, which also lists 10 linked publications.
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 7 Dec 2018.