Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02977221
• Date of registration: 23/11/2016
• Prospective Registration: No
• Primary sponsor: Damascus University
• Public title: Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment
• Scientific title: Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
• Date of first enrolment: March 2016
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02977221
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Syrian Arab Republic

Contacts

• Name: Mohammad Y Hajeer, DDS MSc PhD
• Affiliation: Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

• Name: Omar Gibreal, DDS
• Affiliation: MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School

• Name: Bassel Brad, DDS MSc PhD
• Affiliation: Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult healthy patients , Male and female, Age range: 15-27 years.

2. Severe crowding = 7 (Little's irregularity index)

3. Permanent occlusion.

4. Exist all the Mandibular teeth (except third molars).

5. Good oral and periodontal health:

- Probing depth<4 mm

- No radiographic evidence of bone loss .

- Gingival index= 1

- Plaque index = 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)

2. Patients have anti indication for oral surgery ( medical - social - psycho)

3. Presence of primary teeth in the mandibular arch

4. Missing permanent mandibular teeth (except third molars).

5. Poor oral hygiene or Current periodontal disease:

- Probing depth = 4 mm

- radiographic evidence of bone loss

- Gingival index > 1

- Plaque index > 1

6. Patient had previous orthodontic treatment



Age minimum: 15 Years
Age maximum: 27 Years
Gender: All

Health Condition(s) or Problem(s) studied

Surgical Incision

Malocclusion

Intervention(s)

Procedure: Piezosurgery

Primary Outcome(s)

Change in Tooth Alignment at two months [Time Frame: Little Index of Irregularity will be measured at 60 days after the onset of treatment.]

Duration of tooth alignment [Time Frame: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation]

Change in Tooth Alignment at one month [Time Frame: Little Index of Irregularity will be measured at 30 days after the onset of treatment.]

Change in Tooth Alignment at last assessment time [Time Frame: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.]

Secondary ID(s)

UDDS-OMFS-01-2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors