Efficacy and Periodontal Parameters in Self-ligating Brackets Alone or With Corticotomy vs Conventional Brackets

NCT ID: NCT04950829

Last Updated: 2021-07-06

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2020-08-15

Brief Summary

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Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

Detailed Description

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The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems.

Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time.

Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.

Conditions

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Crowding of Anterior Maxillary Teeth

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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Conventional brackets

Patients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth.

Group Type ACTIVE_COMPARATOR

Conventional brackets

Intervention Type DEVICE

These brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets.

Self-ligating brackets

Patients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth.

Group Type EXPERIMENTAL

Self-ligating brackets

Intervention Type DEVICE

These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.

3- Self-Ligating brackets with fapless corticotomy

Patients will receive an orthodontic treatment using self-ligating brackets with corticotomy until achieving appropriate alignment of the upper anterior teeth.

Group Type EXPERIMENTAL

Self-Ligating Brackets with flapless corticotomy

Intervention Type PROCEDURE

These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.

Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only.

Interventions

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Conventional brackets

These brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets.

Intervention Type DEVICE

Self-ligating brackets

These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.

Intervention Type DEVICE

Self-Ligating Brackets with flapless corticotomy

These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.

Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars.
* The Little's Index of Irregularity is more than 7 mm.
* Good oral health (plaque Index is less or equal to 1).
* Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0).
* Overbite is between 0-4 mm.
* No skeletal constriction on the upper jaw.
* No congenitally missing or extracted teeth (except for the third molars).

Exclusion Criteria

* Any systemic diseases affect teeth movement.
* Any congenital syndromes or cleft lip and palate.
* Bad oral health.
* The patient is not committed to periodic follow-up times.
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 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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Heba M AL-Ibrahim, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student at the Orthodontic Department, University of Damascus Dental

Mohammad Y Hajeer

Role: STUDY_CHAIR

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

Issam Khoury, DDS,MSc,PhD

Role: STUDY_DIRECTOR

Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria

Locations

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Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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Bergamo AZ, Nelson-Filho P, Romano FL, da Silva RA, Saraiva MC, da Silva LA, Matsumoto MA. Gingival crevicular fluid volume and periodontal parameters alterations after use of conventional and self-ligating brackets. J Orthod. 2016 Dec;43(4):260-267. doi: 10.1080/14653125.2016.1221214. Epub 2016 Sep 8.

Reference Type BACKGROUND
PMID: 27607519 (View on PubMed)

Chhibber A, Agarwal S, Yadav S, Kuo CL, Upadhyay M. Which orthodontic appliance is best for oral hygiene? A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Feb;153(2):175-183. doi: 10.1016/j.ajodo.2017.10.009.

Reference Type BACKGROUND
PMID: 29407494 (View on PubMed)

Pandis N, Vlachopoulos K, Polychronopoulou A, Madianos P, Eliades T. Periodontal condition of the mandibular anterior dentition in patients with conventional and self-ligating brackets. Orthod Craniofac Res. 2008 Nov;11(4):211-5. doi: 10.1111/j.1601-6343.2008.00432.x.

Reference Type BACKGROUND
PMID: 18950317 (View on PubMed)

Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.

Reference Type BACKGROUND
PMID: 27891568 (View on PubMed)

Mulla Issa FHK, Mulla Issa ZHK, Rabah AF, Hu L. Periodontal parameters in adult patients with clear aligners orthodontics treatment versus three other types of brackets: A cross-sectional study. J Orthod Sci. 2020 Feb 12;9:4. doi: 10.4103/jos.JOS_54_17. eCollection 2020.

Reference Type BACKGROUND
PMID: 32166083 (View on PubMed)

Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.

Reference Type BACKGROUND
PMID: 24326120 (View on PubMed)

Other Identifiers

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UDDS-Ortho-05-2021

Identifier Type: -

Identifier Source: org_study_id

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