Clinical trial NCT02975765: Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth
Official title: Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Crowded Teeth
Surgical Incision
Keywords: corticotomy
minimally invasive
piezosurgery
piezocision
pain
discomfort
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

Detailed description: According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.

Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

Eligibility criteria: Inclusion Criteria:

1. Adult healthy patients , Male and female, Age range: 16-26 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

Primary outcomes:
measure: Levels of Pain and Discomfort at one day
timeFrame: at 24 hours following the engagement of first initial arch wire in the brackets
measure: Levels of Pain and Discomfort at seven days
timeFrame: at seven days following the onset of orthodontic treatment
measure: Levels of Pain and Discomfort at 14 days
timeFrame: at 14 days following the onset of orthodontic treatment
measure: Levels of Pain and Discomfort at 28 days
timeFrame: at 28 days following the onset of orthodontic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School
Study officials:
affiliation: MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
name: Omar Gibreal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
name: Bassel Brad, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
citation: Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
citation: Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
citation: Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.