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Dental Biofilm Control During Orthodontic Treatment (ORTHOBIOFILM)

Primary Purpose

Gingivitis, Malocclusion

Status
Recruiting
Phase
Phase 3
Locations
Croatia
Study Type
Interventional
Intervention
fixed metal orthodontic appliance
fixed non-metal orthodontic appliance
oral hygiene
Chlorhexidine mouthwash
Sponsored by
University of Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gingivitis focused on measuring malocclusion, gingivitis, dental biofilm

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rijeka, Faculty of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

metal + OH

metal + CHX

non-metal + OH

non-metal + CHX

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

bacterial composition of dental biofilm
bacterial ratio in dental biofilm (molecular biology analysis)
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

Secondary Outcome Measures

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
pH of biofilm
colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity)
extent of gingivitis
Full mouth bleeding score on a scale 0-100%, higher score means worse outcome
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

Full Information

First Posted
May 23, 2022
Last Updated
September 3, 2022
Sponsor
University of Rijeka
Collaborators
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT05532241
Brief Title
Dental Biofilm Control During Orthodontic Treatment
Acronym
ORTHOBIOFILM
Official Title
Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rijeka
Collaborators
University of Ljubljana

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Malocclusion
Keywords
malocclusion, gingivitis, dental biofilm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2 types of appliances and 2 experimental conditions
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metal + OH
Arm Type
Experimental
Arm Description
fixed metal orthodontic appliance with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Arm Title
metal + CHX
Arm Type
Experimental
Arm Description
fixed metal orthodontic appliance with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Arm Title
non-metal + OH
Arm Type
Placebo Comparator
Arm Description
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with regular oral hygiene (toothbrush + toothpaste with low concentration of fluorides 1450 ppm)
Arm Title
non-metal + CHX
Arm Type
Active Comparator
Arm Description
fixed non-metal orthodontic appliance (ceramic brackets + nylon thread) with antiseptic mouthwash one-month use (0.12% chlorhexidine digluconate)
Intervention Type
Device
Intervention Name(s)
fixed metal orthodontic appliance
Intervention Description
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
Intervention Name(s)
fixed non-metal orthodontic appliance
Intervention Description
fixed non-metal orthodontic appliance (ceramic brackets (Radiance MBT 0.022'', American Orthodontics), nylon thread, elastomeric ligatures (Elastomerics, American Orthodontics))
Intervention Type
Procedure
Intervention Name(s)
oral hygiene
Intervention Description
conducting regular oral hygiene, commonly recommended for orthodontic patients (toothbrush + toothpaste with a low fluoride concentration of 1450 ppm (Parodontax, GSK)
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
0.12% chlorhexidine digluconate mouthwash (Curasept ADS 212, Curaden) daily during one month
Primary Outcome Measure Information:
Title
bacterial composition of dental biofilm
Description
bacterial ratio in dental biofilm (molecular biology analysis)
Time Frame
90 days (change from start to 2 months and 3 months after start)
Title
gingival enlargement
Description
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
Time Frame
90 days (change from start to 2 months and 3 months after start)
Secondary Outcome Measure Information:
Title
dental biofilm accumulation
Description
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
Time Frame
90 days (change from start to 2 months and 3 months after start)
Title
pH of biofilm
Description
colorimetric test with pH scale in range 4-7, lower score means worse outcome (higher acidity)
Time Frame
90 days (change from start to 2 months and 3 months after start)
Title
extent of gingivitis
Description
Full mouth bleeding score on a scale 0-100%, higher score means worse outcome
Time Frame
90 days (change from start to 2 months and 3 months after start)
Title
oral health-related quality of life
Description
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
Time Frame
90 days (change from start to 2 months and 3 months after start)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stjepan Spalj, PhD
Phone
+385916119853
Email
stjepan.spalj@fdmri.uniri.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Zigante, PhD
Phone
+385981306006
Email
mzigante0@gmail.com
Facility Information:
Facility Name
University of Rijeka, Faculty of Dental Medicine
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stjepan Spalj, PhD
Phone
385916119853
Email
stjepan.spalj@fdmri.uniri.hr
First Name & Middle Initial & Last Name & Degree
Martina Zigante, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared on reasonable request.
IPD Sharing Time Frame
March 2024
IPD Sharing Access Criteria
No criteria established
Links:
URL
https://sites.google.com/view/ip-2020-02/početna-stranica
Description
This research is a part of a larger project described on this site

Learn more about this trial

Dental Biofilm Control During Orthodontic Treatment

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