NCT05532241

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
1mo left

Started Nov 2021

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2021Jun 2026

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

May 23, 2022

Last Update Submit

January 28, 2026

Conditions

GingivitisMalocclusion

Keywords

malocclusiongingivitisdental biofilm

Outcome Measures

Primary Outcomes (2)

  • bacterial composition of dental biofilm

    bacterial ratio in dental biofilm (molecular biology analysis)

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

  • 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

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

Secondary Outcomes (4)

  • dental biofilm accumulation

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

  • pH of biofilm

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

  • extent of gingivitis

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

  • oral health-related quality of life

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

Study Arms (4)

metal + OH

EXPERIMENTAL

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

Device: fixed metal orthodontic applianceProcedure: oral hygiene

metal + CHX

EXPERIMENTAL

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

Device: fixed metal orthodontic applianceDrug: Chlorhexidine mouthwash

non-metal + OH

PLACEBO COMPARATOR

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

Device: fixed non-metal orthodontic applianceProcedure: oral hygiene

non-metal + CHX

ACTIVE COMPARATOR

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

Device: fixed non-metal orthodontic applianceDrug: Chlorhexidine mouthwash

Interventions

fixed metal orthodontic applianceDEVICE

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))

Also known as: Mini Master MBT 0.022'' and nickel-titanium archwire (American Orthodontics)
metal + CHXmetal + OH
fixed non-metal orthodontic applianceDEVICE

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

Also known as: Radiance MBT 0.022'' (American Orthodontics) and polyamide thread
non-metal + CHXnon-metal + OH
oral hygienePROCEDURE

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

Also known as: Parodontax (GSK)
metal + OHnon-metal + OH
Chlorhexidine mouthwashDRUG

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

Also known as: Parodontax (GSK) + Curasept ADS 212 (Curadent)
metal + CHXnon-metal + CHX

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Rijeka Faculty of Dental Medicine

Rijeka, 51000, Croatia

Location

University of Rijeka, Faculty od Dental Medicine, Dental Clinic

Rijeka, 51000, Croatia

Location

University of Rijeka, Faculty of Dental Medicine

Rijeka, 51000, Croatia

Location

Related Links

MeSH Terms

Conditions

GingivitisMalocclusion

Interventions

Oral HygieneParodontaxhalofantrine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPreventive DentistryDentistry

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 types of appliances and 2 experimental conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

September 8, 2022

Study Start

November 1, 2021

Primary Completion

May 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
March 2024
Access Criteria
No criteria established

Locations

CR(3)