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

NCT02975765 | Completed DMC

• 1 other identifier: UDDS-OMFS-02-2016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Crowded Teeth; Surgical Incision

Keywords

corticotomy; minimally invasive; piezosurgery; piezocision; pain; discomfort

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Piezosurgery

EXPERIMENTAL

Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment

Procedure: Piezosurgery

Traditional method

NO INTERVENTION

No intervention is going to be applied to the patients in this group.

Interventions

Piezosurgery PROCEDURE

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

Also known as: Piezocision

Piezosurgery

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult healthy patients , Male and female, Age range: 16-26 years.
• Severe crowding ≤ 7 (Little's irregularity index)
• Permanent occlusion.
• Exist all the Mandibular 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

You may not qualify if:

• Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
• Patients have anti indication for oral surgery ( medical - social - psycho)
• Presence of primary teeth in the mandibular arch
• Missing permanent mandibular 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (4)

• 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.

  PMID: 22105680 BACKGROUND

• 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.

  PMID: 17726988 BACKGROUND

• 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.

  PMID: 24286911 BACKGROUND

• 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.

  PMID: 30991984 DERIVED

MeSH Terms

Conditions

Malocclusion; Crowding; Surgical Wound; Pain

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Omar Gibreal, DDS

  MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Bassel Brad, DDS MSc PhD

  Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School

  STUDY DIRECTOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: March 1, 2016
• Primary Completion: December 12, 2016
• Study Completion: April 23, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)