Effect of Different Cleaning Regimes on Biofilm Formation of Acrylic Based Removable Orthodontic Appliance

January 27, 2023 updated by: Dheaa Hussein Al-Groosh, University of Baghdad
This study is to evaluate the effects of different cleaning regimes i.e. chemical and mechanical on biofilm formation of an acrylic based removable orthodontic appliance and to find out if surface modification i.e. polished acrylic fitting surface, have an impact on cleaning the biofilm formation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is double-blind, parallel, randomized clinical trial conducted in the orthodontic clinic after obtaining the ethical approval from the ethics committee of the department. Thirty nine orthodontic patients who meet the eligibility criteria will be included in the study and will be provided by the patient information sheet and consent form that will explain the nature of the study. After initial approval from the patient an alginate impression of the maxillary arch will be taken and a negative replica will be made by type IV stone. The wire framework of the removable appliance will be fabricated according to the design for the case. After applying a separating medium, an acrylic base will be fabricated using the orthodontic acrylic powder and liquid (Orthocryle, Dentaurum, Ispringen, German) with a ratio of (2.5 parts powder to 1 part liquid) according to the manufacturer's instruction with four wells on each side of the fitting surface of the appliance. Acrylic samples i.e. tiles of different surface texture will be made. An acrylic sheet of 1 mm thickness will be made using a mold material. One sheet will be polished using a conventional polishing technique until a glossy surface appears, whereas, the other sheet will be kept without modification. Tiles of 5mm in diameter will be bored using a trephine bur on both sides of the acrylic sheets and each set of tiles i.e. the polished and unpolished samples will be color coated from its seated surface. The acrylic tiles (5mm in diameter and 1mm thickness) will be placed and fixed into the holes created using sticky wax. The acrylic samples will be randomly seated, The appliance will be sterilized using proper sterilization protocol. The removable appliance will be assigned randomly and blindly and fitted into the oral cavity of the patient for one week. Each individual will be given by an independent person a pack containing the cleansing pack and an instruction sheet describing the cleaning regimen for his/ her appliance. The packs are similar in shape and color and will be prepared by a third person who does not know the purpose of the study. The participant will be grouped into three groups:

  1. Brushing with denture brush and chlorhexidine (CHX) toothpaste (lacalut Active, Germany) for one minute.
  2. Chemical cleaning i.e. Lacalut cleaning tablet (lacalut DENT cleaning tab, Germany), fill the cup to the marked line (150 mL) with tap water, dissolve one cleansing tablet and wait for 20 minutes then wash it with tap water.
  3. Combination of brushing with CHX toothpaste and cleaning tablet. At the end of the study period, the acrylic samples will be removed carefully and applied into a petri dish containing PBS via a sterile tweezer. The samples will be then immersed twice in a 25ml sterile tubes containing PBS to remove the planktonic bacteria and inserted into 5ml bijou tube containing 1mm PBS. The sample will be vortex mixed for 1 minute to disseminate the biofilm and create a homogenous solution. Ten-fold serial dilutions will be carried out in PBS before the samples are plated onto blood agar (BA), to give the total anaerobic count, mitis salivarius agar (MS), a selective agar for streptococci spp. and Mannitol salt agar (MA) for Staphylococci spp. BA and MS plates will be incubated anaerobically for 2-4 days at 37ºC using anaerobic cabinet whereas the MA will be incubated for 2 days in aerobic condition. All organisms from both selective and nonselective agars will be distinguished by colony morphology and will be characterized by Gram reaction and other confirmatory tests: 1. Catalase testing 2. Coagulase testing

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

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

  • Iraq
    • Bab-Almuadham
      • Baghdad, Bab-Almuadham, Iraq, 10047
        • Recruiting
        • Baghdad college of dentistry

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

7 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of full upper permanent dentition
  • Well-aligned teeth or mild crowding (less than 3mm)
  • No history of sensitivity to any ingredient contained in the cleaning materials
  • Nonsmoker
  • Caries free

Exclusion Criteria:

  • Participant taking steroid-based or antibacterial mouthwash or broad-spectrum antibiotics
  • Mouth breather
  • Participant taking medication that reduces salivary flow
  • Pregnant lactating female

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: mechanical cleaning method by denture brush and Chlorhexidine toothpaste
patients will be instructed to brush both sides of the removable appliance once a day for 1 minute before bedtime using the toothbrush and the CHX toothpaste provided and water
Other: cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste
mechanical cleaning of removable appliance by the patient for 7 days before bedtime for one minute
Other Names:
  • Denture brush (Foramen denture brush, Spain), CHX toothpaste(Lacalute Active, Germany)
ACTIVE_COMPARATOR: chemical cleaning method with cleaning tablet
patients will be instructed to immerse the appliance in 150 ml cup with tap water and dissolve one cleansing tablet for 20 minutes according to the manufacture instructions.
Other: cleaning removable acrylic appliance with cleansing tablet
chemical cleaning by patient for 7 days with cleansing tablet
Other Names:
  • cleansing tablet (Lacalute cleansing tablet, Germany)
ACTIVE_COMPARATOR: combination of mechanical and chemical cleaning
first submitted to the mechanical method, followed by the chemical method.
Other: combination of mechanical and chemical cleaning
cleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet
Other Names:
  • cleaning with brushing then with the cleaning tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbial evaluation between the three cleaning methods
Time Frame: 7 days
numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbial evaluation between the polished and unpolished acrylic discs
Time Frame: 7 days
numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.
7 days

Collaborators and Investigators

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

Sponsor

University of Baghdad

Investigators

  • Study Director: Dheaa Al-Groosh, Ph.D, university of Baghdad, college of dentistry

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.

General Publications

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)

April 17, 2022

Primary Completion (ANTICIPATED)

February 25, 2023

Study Completion (ANTICIPATED)

April 30, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cleaning of ROA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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