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

Evaluation of Leveling and Alignment Time and the Periodontal Status in Patients With Severe Upper Crowding Treated by Flapless Corticotomy-assisted Self-ligating Brackets in Comparison With Conventional or Self-Ligating Brackets Alone

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.

Study Overview

• Status: Completed
• Conditions: Crowding of Anterior Maxillary Teeth
• Intervention / Treatment: Device: Conventional brackets; Device: Self-ligating brackets; Procedure: Self-Ligating Brackets with flapless corticotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional brackets; Patients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth.	Device: 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.
EXPERIMENTAL: Self-ligating brackets; Patients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth.	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.
EXPERIMENTAL: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the plaque index.	Assessment will be achieved using a gingival probe according to Silness and Loe (1964). A. (0) = No plaque. B. (1) = A film of plaque stick to the free gingival margin and adjacent area of the tooth. C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket. D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.	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	Assessment will be achieved using a gingival probe according to Silness and Loe (1964). A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing. C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing. D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding	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.	Assessment will be achieved using a gingival probe according to Muhlemann (1977). A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears. D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.	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	Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus.	T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Heba M AL-Ibrahim, DDS, MSc student at the Orthodontic Department, University of Damascus Dental; Study Chair: Mohammad Y Hajeer, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria; Study Director: Issam Khoury, DDS,MSc,PhD, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2018
• Primary Completion (ACTUAL): September 15, 2019
• Study Completion (ACTUAL): August 15, 2020

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-Ortho-05-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No