Mesial Movement of TeethNCT04055935
Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
A study testing elevation of full thickness mucoperiosteal flap and low level laser therapy in people with Mesial Movement of Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 15 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mesial Movement of Teeth
- What is being tested?
- elevation of full thickness mucoperiosteal flap and low level laser therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Jun 2019
- 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 15 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- o Free of any syndromes affecting the head region or any craniofacial injuries.
- No history of previous orthodontic treatment
- All of the permanent dentition present excluding third molars.
- Good oral hygiene before starting treatment.
- Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.
- Malocclusion cases that allow initial stage of leveling and alignment without extraction.
Who cannot join
- o Patients with systemic diseases especially bleeding disorders and osteoporosis.
- History of administration of corticosteroids, exogenous hormones and non-steroidal anti-inflammatory drugs (all drugs interfere with OTM).
- Presence of previous history of oral surgeries in maxillary arch.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement.
Read the detailed description
This study was a split mouth design study included 32 side according to sample size calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8 sides control). Extraction of the first maxillary premolars followed by canine retraction in the extraction space with maximum anchorage were indicated. FTMPF was elevated from the mesial interdental papilla of maxillary canine to the mesial interdental papilla of second maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital superimposition was done to measure the rate of canine retraction and anchorage loss.
- Conditions
- Mesial Movement of Teeth
- Being tested
- elevation of full thickness mucoperiosteal flap, low level laser therapy
- Medical subject headings
- Mesial Movement of Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elevation of full thickness mucoperiosteal flapProcedure or surgery
A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.
low level laser therapyDevice
LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)
| Study group | Role | What they receive |
|---|---|---|
| full thickness mucoperiosteal flap | Experimental | A full thickness mucoperiosteal flap (FTMPF) was reflected on FTMPF side at the maxillary canine/premolar region by the same surgeon for all patients following the same procedures. Receives: Procedure: elevation of full thickness mucoperiosteal flap |
| low level laser therapy | Experimental | LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length Receives: Device: low level laser therapy |
| Control for Full thickness mucoperiosteal flap | No intervention | Control for Full thickness mucoperiosteal flap, in which canine retraction was done in a conventional method |
| control for Low level laser therapy group | No intervention | Control for Low level laser therapy , in which canine retraction was done in a conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction
measure the rate of canine retraction on series of study models
Measured: the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction
Secondary outcomes (1)
clinical mesial movement of first maxillary molar measured by millimeter on the 3D model
amount of mesial movement of first maxillary molar after 24 month
Measured: t0(start of canine retraction) to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2017
- Primary completion1 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesial Movement of TeethStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- split mouth study design, side intervention and other side for control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsena Ahmad, Al-Azhar University
- Investigators
- Mohsena a arazik, orthodontist, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055935
- Sponsor's protocol ID
- Doctor's degree research
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be shared the weekly rate and distance of canine retraction, the amount of maxillary canine mesial movement and the periodontal pocket depth around the maxillary canine
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
- ClinicalTrials.gov ID
- NCT04055935
- Acronym / sponsor ID
- Doctor's degree research
- Conditions
- Mesial Movement of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 14 Aug 2019 (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.
This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement.
Detailed description
This study was a split mouth design study included 32 side according to sample size calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8 sides control). Extraction of the first maxillary premolars followed by canine retraction in the extraction space with maximum anchorage were indicated. FTMPF was elevated from the mesial interdental papilla of maxillary canine to the mesial interdental papilla of second maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital superimposition was done to measure the rate of canine retraction and anchorage loss.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- split mouth study design, side intervention and other side for control
| Arm | Type | Receives |
|---|---|---|
| full thickness mucoperiosteal flap | Experimental | Procedure: elevation of full thickness mucoperiosteal flapA full thickness mucoperiosteal flap (FTMPF) was reflected on FTMPF side at the maxillary canine/premolar region by the same surgeon for all patients following the same procedures. |
| low level laser therapy | Experimental | Device: low level laser therapyLLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length |
| Control for Full thickness mucoperiosteal flap | No intervention | –Control for Full thickness mucoperiosteal flap, in which canine retraction was done in a conventional method |
| control for Low level laser therapy group | No intervention | –Control for Low level laser therapy , in which canine retraction was done in a conventional method |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- o Free of any syndromes affecting the head region or any craniofacial injuries.
Key exclusion criteria (3 listed)
- o Patients with systemic diseases especially bleeding disorders and osteoporosis.
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 |
|---|---|---|
| elevation of full thickness mucoperiosteal flapA free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine. | Procedure or surgery | full thickness mucoperiosteal flap |
| low level laser therapyLLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip) | Device | low level laser therapy |
Primary outcome
rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction
Time frame: the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction
measure the rate of canine retraction on series of study models
1 secondary outcome
clinical mesial movement of first maxillary molar measured by millimeter on the 3D model
Time frame: t0(start of canine retraction) to 24 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 20 Aug 2019.
- Individual participant dataSharing planned: Yes. the data will be shared the weekly rate and distance of canine retraction, the amount of maxillary canine mesial movement and the periodontal pocket depth around the maxillary canine
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.
Mohsena a arazik, orthodontist principal investigator
Al-Azhar 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 elevation of full thickness mucoperiosteal flap and low level laser therapy in people with Mesial Movement of Teeth, 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 6 inclusion and 3 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 20 Aug 2019. 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 orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction (time frame: the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction). 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 20 Aug 2019.