Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment

NCT ID: NCT04348526

Last Updated: 2020-04-16

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-02-15

Brief Summary

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

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Detailed Description

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

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.

Conditions

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

Crowding

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.

Corticision

Patients will undergo a corticision procedure in order to accelerate tooth movement

Group Type EXPERIMENTAL

Corticision

Intervention Type PROCEDURE

Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made

Traditional treatment

Patients will undergo traditional orthodontic treatment without any surgical intervention.

Group Type ACTIVE_COMPARATOR

Traditional orthodontic treatment

Intervention Type PROCEDURE

No surgical intervention will be used, just normal orthodontic sequence of procedures.

Interventions

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

Corticision

Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made

Intervention Type PROCEDURE

Traditional orthodontic treatment

No surgical intervention will be used, just normal orthodontic sequence of procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

1. Age range between 18 and 24 years
2. Completion permanent dentition (except third molars)
3. Mild to moderate crowding (2-6 mm according to Little's index)
4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion Criteria

1. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
3. Patients had previous orthodontic treatments
4. Poor oral hygiene or concurrent periodontal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 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.

Mohamad Radwan Sirri, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

MSc student in Orthodontics, University of Damascus Dental School

Ahmad S Burhan, DDS MSc PhD

Role: STUDY_CHAIR

Professor of Orthodontics, University of Damascus, Damascus, Syria

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Orthodontics, University of Damascus Dental School, Damascus, SYRIA

Locations

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

Orthodontic Department, 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.

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 BACKGROUND
PMID: 30991984 (View on PubMed)

Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.

Reference Type BACKGROUND
PMID: 29853235 (View on PubMed)

Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.

Reference Type BACKGROUND
PMID: 27129491 (View on PubMed)

Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.

Reference Type BACKGROUND
PMID: 28371882 (View on PubMed)

Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.

Reference Type BACKGROUND
PMID: 30370430 (View on PubMed)

Other Identifiers

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

UDDS-Ortho-03-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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