Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment

NCT ID: NCT05250921

Last Updated: 2022-02-22

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-09

Study Completion Date

2020-08-26

Brief Summary

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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, disicion, micro-osteoperforation, and piezopuncture 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

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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 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 malocclusions.

Conditions

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Crowding, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Corticision

Corticision will be performed on the lower anterior teeth using a surgical blade and a hammer.

Group Type EXPERIMENTAL

Corticision

Intervention Type PROCEDURE

Corticision will be performed to enhance teeth alignment.

Conventional method

A fixed appliance will be applied using conventional braces without any surgical procedure.

Group Type ACTIVE_COMPARATOR

Conventional fixed appliance

Intervention Type DEVICE

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

Interventions

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Corticision

Corticision will be performed to enhance teeth alignment.

Intervention Type PROCEDURE

Conventional fixed appliance

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age range between 18 and 24 years
2. Completion of 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

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamad Radwan Sirri, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics, Damascus University, Syria

Ahmad S Burhan, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Fehmieh R Nawaya, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor, Department of Pediatric Dentistry,Syrian PrivateUniversity

Rashad MT Murad, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Toxins and Pharmaceutics, University of Damascus, Faculty of Pharmacology

Locations

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University of Damascus

Damascus, , Syria

Site Status

Countries

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Syria

References

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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)

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)

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)

Other Identifiers

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UDDS-Ortho-03-2022

Identifier Type: -

Identifier Source: org_study_id

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