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

NCT04950829 | Completed DMC

• 1 other identifier: UDDS-Ortho-05-2021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crowding of Anterior Maxillary Teeth

Outcome Measures

Primary Outcomes (1)

• Duration of teeth alignment

  The number of days required to finish the alignment stage of upper teeth will be calculated from the beginning of treatment till the end of the alignment stage (i.e. teeth alignment is achieved)

  This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days

Secondary Outcomes (4)

• The change in the plaque index.

  T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months

• The change in the gingival index

  T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months

• The change in papillary bleeding index.

  T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months

• The change in the probing depth

  T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months

Study Arms (3)

Conventional brackets

ACTIVE COMPARATOR

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

Device: Conventional brackets

Self-ligating brackets

EXPERIMENTAL

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

Device: Self-ligating brackets

3- Self-Ligating brackets with fapless corticotomy

EXPERIMENTAL

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

Procedure: Self-Ligating Brackets with flapless corticotomy

Interventions

Conventional brackets 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.

Conventional brackets

Self-ligating brackets 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.

Self-ligating brackets

Self-Ligating Brackets with flapless corticotomy 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.

3- Self-Ligating brackets with fapless corticotomy

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 27607519 BACKGROUND

• 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.

  PMID: 29407494 BACKGROUND

• 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.

  PMID: 18950317 BACKGROUND

• 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.

  PMID: 27891568 BACKGROUND

• 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.

  PMID: 32166083 BACKGROUND

• 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.

  PMID: 24326120 BACKGROUND

Study Officials

• Heba M AL-Ibrahim, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer

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

  STUDY CHAIR

• Issam Khoury, DDS,MSc,PhD

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

  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: June 19, 2021
• First Posted: July 6, 2021
• Study Start: August 8, 2018
• Primary Completion: September 15, 2019
• Study Completion: August 15, 2020
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)