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GingivitisPhase 3ORTHOBIOFILMNCT05532241

Dental Biofilm Control During Orthodontic Treatment

A Phase 3 study testing fixed metal orthodontic appliance, fixed non-metal orthodontic appliance and oral hygiene in people with Gingivitis and Malocclusion, run by University of Rijeka at 3 sites in Croatia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Gingivitis, Malocclusion
What is being tested?
fixed metal orthodontic appliance, fixed non-metal orthodontic appliance and oral hygiene
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
3 sitesCroatia
Study dates
1 Nov 2021to 1 Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • neurodevelopmental disorders
  • intellectual disability
  • oligodontia
  • congenital craniofacial anomalies
  • orofacial clefts

Trial locations and contacts

3 sites in 1 country.

Croatia3 sites

  • University of Rijeka Faculty of Dental Medicine

    Rijeka, 51000

  • University of Rijeka, Faculty od Dental Medicine, Dental Clinic

    Rijeka, 51000

  • University of Rijeka, Faculty of Dental Medicine

    Rijeka, 51000

Other trials in Croatia

About this study

Official title: 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.

Read the 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.
Being tested
fixed metal orthodontic appliance, fixed non-metal orthodontic appliance, oral hygiene, Chlorhexidine mouthwash
Keywords
malocclusion, gingivitis, dental biofilm
Medical subject headings
Gingivitis, Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fixed metal orthodontic applianceDevice

    Also called Mini Master MBT 0.022'' and nickel-titanium archwire (American Orthodontics)

    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))

  • fixed non-metal orthodontic applianceDevice

    Also called Radiance MBT 0.022'' (American Orthodontics) and polyamide thread

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

  • oral hygieneProcedure or surgery

    Also called Parodontax (GSK)

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

  • Chlorhexidine mouthwashDrug

    Also called Parodontax (GSK) + Curasept ADS 212 (Curadent)

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

Study groups in NCT05532241
Study groupRoleWhat they receive
metal + OHExperimentalfixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Receives: Device: fixed metal orthodontic appliance; Procedure: oral hygiene
metal + CHXExperimentalfixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Receives: Device: fixed metal orthodontic appliance; Drug: Chlorhexidine mouthwash
non-metal + OHPlacebo comparatorfixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Receives: Device: fixed non-metal orthodontic appliance; Procedure: oral hygiene
non-metal + CHXActive comparatorfixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Receives: Device: fixed non-metal orthodontic appliance; Drug: Chlorhexidine mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bacterial composition of dental biofilm

    bacterial ratio in dental biofilm (molecular biology analysis)

    Measured: 90 days (change from start to 2 months and 3 months after start)

  2. gingival enlargement

    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

    Measured: 90 days (change from start to 2 months and 3 months after start)

Secondary outcomes (4)

  1. dental biofilm accumulation

    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

    Measured: 90 days (change from start to 2 months and 3 months after start)

  2. pH of biofilm

    colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity)

    Measured: 90 days (change from start to 2 months and 3 months after start)

  3. extent of gingivitis

    Full mouth bleeding score on a scale 0-100%, higher score means worse outcome

    Measured: 90 days (change from start to 2 months and 3 months after start)

  4. oral health-related quality of life

    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

    Measured: 90 days (change from start to 2 months and 3 months after start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start1 Nov 2021
  3. Primary completion1 May 2025
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 types of appliances and 2 experimental conditions
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05532241
Sponsor's protocol ID
IP-2020-02-4027
Acronym
ORTHOBIOFILM
Status last verified
Jan 2026
First submitted
23 May 2022
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be shared on reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fixed metal orthodontic appliance, fixed non-metal orthodontic appliance and oral hygiene in people with Gingivitis and Malocclusion, run by University of Rijeka at 3 sites in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bacterial composition of dental biofilm (time frame: 90 days (change from start to 2 months and 3 months after start)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05532241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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