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Dental Biofilm Control During Orthodontic Treatment

NCT ID: NCT05532241

Last Updated: 2024-12-30

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-06-01

Brief Summary

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Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.

Detailed Description

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The aim is:

* to determine the clinical characteristics of gingiva of subjects not exposed to metals of dental alloys and exposed to metals
* characterization of microbiome of dental biofilm in subjects not exposed to metals of dental alloys and exposed to metals and to determine changes in the structure of dental biofilm due to exposure to metals
* examine the extent to which environmental influences modify the effectiveness of treatment of gingivitis by mechanical removal of biofilm and chemical control (chlorhexidine digluconate mouthwash (CHX))
* to examine the behavior of bacteria of early and late colonizers of dental biofilm after chemical control
* to analyze biofilm on metal and non-metal appliance
* to explore patient reported outcome measures Study design is a randomized controlled trial with 4 parallel groups: (I) fixed metal orthodontic appliance with regular oral hygiene, (II) fixed metal orthodontic appliance with CHX, (III) non-metal fixed orthodontic appliance with regular oral hygiene, and (IV) non-metal orthodontic appliance with CHX.

Conditions

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Gingivitis Malocclusion

Keywords

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malocclusion gingivitis dental biofilm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 types of appliances and 2 experimental conditions
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Groups were labeled as I-IV, appliance is fixed on teeth and visible for both participants and care providers. Mouthwash is also visible. Outcome assessor does not know wether patient was in mouthwash group, but he sees the type of appliance. Microbiologist and statisticians are not aware of the group affiliation.

Study Groups

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metal + OH

fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)

Group Type EXPERIMENTAL

fixed metal orthodontic appliance

Intervention Type DEVICE

fixed metal orthodontic appliance (stainless steel brackets (Mini Master MBT 0.022'', American Orthodontics), nickel-titanium archwire (NiTi, American Orthodontics), elastomeric ligatures (Elastomerics, American Orthodontics))

oral hygiene

Intervention Type PROCEDURE

conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)

metal + CHX

fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)

Group Type EXPERIMENTAL

fixed metal orthodontic appliance

Intervention Type DEVICE

fixed metal orthodontic appliance (stainless steel brackets (Mini Master MBT 0.022'', American Orthodontics), nickel-titanium archwire (NiTi, American Orthodontics), elastomeric ligatures (Elastomerics, American Orthodontics))

Chlorhexidine mouthwash

Intervention Type DRUG

conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

non-metal + OH

fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)

Group Type PLACEBO_COMPARATOR

fixed non-metal orthodontic appliance

Intervention Type DEVICE

fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))

oral hygiene

Intervention Type PROCEDURE

conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)

non-metal + CHX

fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)

Group Type ACTIVE_COMPARATOR

fixed non-metal orthodontic appliance

Intervention Type DEVICE

fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))

Chlorhexidine mouthwash

Intervention Type DRUG

conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

Interventions

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fixed metal orthodontic appliance

fixed metal orthodontic appliance (stainless steel brackets (Mini Master MBT 0.022'', American Orthodontics), nickel-titanium archwire (NiTi, American Orthodontics), elastomeric ligatures (Elastomerics, American Orthodontics))

Intervention Type DEVICE

fixed non-metal orthodontic appliance

fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), polyamide thread, elastomeric ligatures (Elastomerics, American Orthodontics))

Intervention Type DEVICE

oral hygiene

conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)

Intervention Type PROCEDURE

Chlorhexidine mouthwash

conducting regular oral hygiene (Parodontay, GSK) + 0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month

Intervention Type DRUG

Other Intervention Names

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Mini Master MBT 0.022'' and nickel-titanium archwire (American Orthodontics) Radiance MBT 0.022'' (American Orthodontics) and polyamide thread Parodontax (GSK) Parodontax (GSK) + Curasept ADS 212 (Curadent)

Eligibility Criteria

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Inclusion Criteria

* malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3)

Exclusion Criteria

* neurodevelopmental disorders
* intellectual disability
* oligodontia
* congenital craniofacial anomalies
* orofacial clefts
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ljubljana

OTHER

Sponsor Role collaborator

University of Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Stjepan Spalj

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rijeka Faculty of Dental Medicine

Rijeka, , Croatia

Site Status RECRUITING

University of Rijeka, Faculty od Dental Medicine, Dental Clinic

Rijeka, , Croatia

Site Status RECRUITING

University of Rijeka, Faculty of Dental Medicine

Rijeka, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Stjepan Spalj, PhD

Role: CONTACT

Phone: +385916119853

Email: [email protected]

Martina Zigante, PhD

Role: CONTACT

Phone: +385981306006

Email: [email protected]

Facility Contacts

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Stjepan Spalj, PhD

Role: primary

Stjepan Spalj, PhD

Role: primary

Stjepan Spalj, PhD

Role: primary

Related Links

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https://sites.google.com/view/ip-2020-02/početna-stranica

This research is a part of a larger project described on this site

Other Identifiers

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IP-2020-02-4027

Identifier Type: -

Identifier Source: org_study_id