Dental Biofilm Control During Orthodontic Treatment (ORTHOBIOFILM)

December 22, 2023 updated by: Stjepan Spalj, University of Rijeka

Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • Recruiting
        • University of Rijeka, Faculty of Dental Medicine
        • Contact:
        • Principal Investigator:
          • Martina Zigante, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metal + OH
fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Device: 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))
Procedure: oral hygiene
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
Experimental: metal + CHX
fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Device: 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))
Drug: Chlorhexidine mouthwash
0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
Placebo Comparator: 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)
Procedure: oral hygiene
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
Device: fixed non-metal orthodontic appliance
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), nylon thread, elastomeric ligatures (Elastomerics, American Orthodontics))
Active Comparator: non-metal + CHX
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Drug: Chlorhexidine mouthwash
0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
Device: fixed non-metal orthodontic appliance
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), nylon thread, elastomeric ligatures (Elastomerics, American Orthodontics))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial composition of dental biofilm
Time Frame: 90 days (change from start to 2 months and 3 months after start)
bacterial ratio in dental biofilm (molecular biology analysis)
90 days (change from start to 2 months and 3 months after start)
gingival enlargement
Time Frame: 90 days (change from start to 2 months and 3 months after start)
Seymour index (thickness (scale 0=normal-2=thickening >=3mm) + proportion of tooth crown coverage (scale 0=normal-3=papilla involving .2/3 of adjacent tooth crown half) on frontal teeth vestibular and oral in both jaws; scale 0-100), higher score means worse outcome
90 days (change from start to 2 months and 3 months after start)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental biofilm accumulation
Time Frame: 90 days (change from start to 2 months and 3 months after start)
Silness-Loe index and Williams modification for subjects in orthodontic treatment on a scale from 0=no biofilm to 3=a continuous line greater than 1mm, mean value of referent teeth, range 0-3, higher score indicates worse outcome
90 days (change from start to 2 months and 3 months after start)
pH of biofilm
Time Frame: 90 days (change from start to 2 months and 3 months after start)
colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity)
90 days (change from start to 2 months and 3 months after start)
extent of gingivitis
Time Frame: 90 days (change from start to 2 months and 3 months after start)
Full mouth bleeding score on a scale 0-100%, higher score means worse outcome
90 days (change from start to 2 months and 3 months after start)
oral health-related quality of life
Time Frame: 90 days (change from start to 2 months and 3 months after start)
Oral Health Impact Profile (modification for gingivitis), 8 items, each on a scale 0=never-4=very often, range 0-32, higher score means worse outcome
90 days (change from start to 2 months and 3 months after start)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rijeka

Collaborators

University of Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-2020-02-4027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared on reasonable request.

IPD Sharing Time Frame

March 2024

IPD Sharing Access Criteria

No criteria established

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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