Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975765
• Other study ID #: UDDS-OMFS-02-2016
• Status: Completed
• Phase: N/A
• First received: November 24, 2016
• Last updated: July 26, 2017
• Start date: March 2016
• Est. completion date: April 23, 2017

Study information

• Verified date: July 2017
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 23, 2017
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Crowded Teeth
• Malocclusion
• Surgical Incision

Intervention

Procedure:
• Piezosurgery
The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.

Locations

Country	Name	City	State
Syrian Arab Republic	Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Pain and Discomfort at one day	Pain and discomfort will be measured on visual analog scale	at 24 hours following the engagement of first initial arch wire in the brackets
Primary	Levels of Pain and Discomfort at seven days	Pain and discomfort will be measured on visual analog scale	at seven days following the onset of orthodontic treatment
Primary	Levels of Pain and Discomfort at 14 days	Pain and discomfort will be measured on visual analog scale	at 14 days following the onset of orthodontic treatment
Primary	Levels of Pain and Discomfort at 28 days	Pain and discomfort will be measured on visual analog scale	at 28 days following the onset of orthodontic treatment