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

NCT ID: NCT02975765

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion Crowded Teeth Surgical Incision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Piezosurgery

Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment

Group Type EXPERIMENTAL

Piezosurgery

Intervention Type PROCEDURE

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

Traditional method

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Piezosurgery

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Piezocision

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damascus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Omar Gibreal, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Bassel Brad, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Damascus, , Syria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Syria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22105680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17726988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24286911 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30991984 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDDS-OMFS-02-2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.