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

Sponsor

University of Baghdad (Other)

Overall Status

Recruiting

CT.gov ID

NCT05707221

Collaborator

(none)

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease	Other: cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste Other: cleaning removable acrylic appliance with cleansing tablet Other: combination of mechanical and chemical cleaning	N/A

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:

Brushing with denture brush and chlorhexidine (CHX) toothpaste (lacalut Active, Germany) for one minute.
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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 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 volunteer will be grouped into three groups: Group 1: patients will be instructed to brush both sides of the removable appliance once a day for 1 minute before bedtime using the denture brush and the CHX toothpaste (lacalut active, Germany) provided and water. Group 2: patients will be instructed to immerse the appliance in 150 ml cup with tap water and dissolve one cleansing (lacalut DENT cleaning tablet, Germany) tablet for 20 minutes according to the manufacture instructions. Group 3: Combination of brushing with CHX and cleaning tablets.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 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 volunteer will be grouped into three groups:Group 1: patients will be instructed to brush both sides of the removable appliance once a day for 1 minute before bedtime using the denture brush and the CHX toothpaste (lacalut active, Germany) provided and water. Group 2: patients will be instructed to immerse the appliance in 150 ml cup with tap water and dissolve one cleansing (lacalut DENT cleaning tablet, Germany) tablet for 20 minutes according to the manufacture instructions. Group 3: Combination of brushing with CHX and cleaning tablets.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Sequence Generation: A computer random generator will be used to develop a simple randomization Allocation Concealment: This will be achieved using sequentially numbered, opaque and sealed envelopes which will be numbered according to the study numbers. Each envelope includes the treatment allocation card (group 1, 2 or 3) and the related cleaning method with instruction card. Blinding: An independent person will be responsible for giving the patient the envelope, all data collection and counting will be completed by a microbiologist who would not know about the study.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 17, 2022

Anticipated Primary Completion Date :

Feb 25, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

microbial evaluation between the three cleaning methods [7 days]
numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.

Secondary Outcome Measures

microbial evaluation between the polished and unpolished acrylic discs [7 days]
numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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