Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment (NCT02606331) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment
Syria36 participantsStarted 2015-04
Plain-language summary
Thirty six patients needs therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into two groups : piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group, piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal arch will be used as an anchor unit.
Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, canine rotation and anchorage loss over a follow-up period until a Class I canine relationship is achieved. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at four assessment times during the first month after the minimally invasive procedure.
Who can participate
Age range
14 Years – 27 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult healthy patients , Male and female , Age range: 15-27 years.
* Class II Division 1 malocclusion :
* Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
* Overjet ≤10
* Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
* Mild to moderate crowding ≤ 4
* Permanent occlusion.
* Existence of all the upper teeth (except third molars).
* Good oral and periodontal health:
* Probing depth \< 4 mm
* No radiographic evidence of bone loss .
* Gingival index ≤ 1
* Plaque index ≤ 1
Exclusion Criteria:
* Medical problems that affect tooth movement (corticosteroid, nonsteroidal antiinflammatory drugs (NSAIDs), …)
* patients have anti indication for oral surgery ( medical - social - psycho)
* Presence of primary teeth in the maxillary arch
* Missing permanent maxillary teeth (except third molars).
* Poor oral hygiene or Current periodontal disease:
* Probing depth ≥ 4 mm
* radiographic evidence of bone loss
* Gingival index \> 1
* Plaque index \> 1
* Patient had previous orthodontic treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of canine retraction
Timeframe: This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which takes up to 12 weeks