Accretions; TeethNCT05167708
Effects of Micro-osteoperforation on the Maxillary First Molar Distalization
A study testing Micro-osteoperforation in people with Accretions; Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing… Read more about this study
- Who is it for?
- Ages 16 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accretions; Teeth
- What is being tested?
- Micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Nov 2021
- 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 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Space deficiency in the upper arch > 5 mm, and < 8 mm.
- Non-extraction lower arch.
- Full upper dentition up to the second molars.
- Third molar present in both sides, not yet erupted.
Who cannot join
- Systemic disease or syndrome.
- Evidence of root resorption.
- Poor oral hygiene.
- Previous orthodontic treatment
- Evidence of bone loss.
- Active periodontal disease.
- Pregnant females.
- Presence of oral habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial
the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.
Read the detailed description
in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.
- Conditions
- Accretions; Teeth
- Being tested
- Micro-osteoperforation
- Medical subject headings
- Dental Deposits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationProcedure or surgery
flapless small punctures in the bone at direction of tooth movement to accelerate the movement.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | the group underwent distalization, with no Micro-osteoperforation |
| Single MOP | Experimental | the group underwent one time Micro-osteoperforation procedure Receives: Procedure: Micro-osteoperforation |
| repeated MOP | Experimental | the group underwent monthly Micro-osteoperforation procedure Receives: Procedure: Micro-osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of maxillary first molar distal movement
evaluation of the whole rate of distal movement of the first molar
Measured: through study completion, an average 1 year
Secondary outcomes (3)
decrease in length of maxillary first molars in mm.
the change in the lengths of roots of maxillary first molars in mm.
Measured: through study completion, an average 1 year
bone density
bone density around the first molar
Measured: through study completion, an average 1 year
pain perception questionnaire
evaluate the pain perception to the intervention
Measured: through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Apr 2019
- Primary completion30 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accretions; TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa alkasaby, Mansoura University
- Investigators
- yasser lotfy, professor, Study chair, Mansoura Universitymarwaa shamaa, ph.D, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167708
- Sponsor's protocol ID
- A03120219
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 22 Dec 2021
- 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 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05167708
- Acronym / sponsor ID
- A03120219
- Conditions
- Accretions; Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 22 Dec 2021 (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.
the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.
Detailed description
in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –the group underwent distalization, with no Micro-osteoperforation |
| Single MOP | Experimental | Procedure: Micro-osteoperforationthe group underwent one time Micro-osteoperforation procedure |
| repeated MOP | Experimental | Procedure: Micro-osteoperforationthe group underwent monthly Micro-osteoperforation procedure |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Space deficiency in the upper arch > 5 mm, and < 8 mm.
- Non-extraction lower arch.
- Full upper dentition up to the second molars.
- Third molar present in both sides, not yet erupted.
Key exclusion criteria (8 listed)
- Systemic disease or syndrome.
- Evidence of root resorption.
- Poor oral hygiene.
- Previous orthodontic treatment
- Evidence of bone loss.
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 |
|---|---|---|
| Micro-osteoperforationflapless small punctures in the bone at direction of tooth movement to accelerate the movement. | Procedure or surgery | Single MOP, repeated MOP |
Primary outcome
rate of maxillary first molar distal movement
Time frame: through study completion, an average 1 year
evaluation of the whole rate of distal movement of the first molar
3 secondary outcomes
decrease in length of maxillary first molars in mm.
Time frame: through study completion, an average 1 year
bone density
Time frame: through study completion, an average 1 year
pain perception questionnaire
Time frame: through study completion, an average 1 year
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 22 Dec 2021.
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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.
yasser lotfy, professor study chair
Mansoura University
marwaa shamaa, ph.D study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-osteoperforation in people with Accretions; Teeth, run by Mansoura 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 4 inclusion and 8 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 22 Dec 2021. 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 maxillary first molar distal movement (time frame: through study completion, an average 1 year). 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 22 Dec 2021.