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

NCT ID: NCT05707221

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-17

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Oral Disease

Keywords

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Oral biofilm Removable Orthodontic appliance Cleaning Removable appliances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste

Intervention Type OTHER

mechanical cleaning of removable appliance by the patient for 7 days before bedtime for one minute

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.

Group Type ACTIVE_COMPARATOR

cleaning removable acrylic appliance with cleansing tablet

Intervention Type OTHER

chemical cleaning by patient for 7 days with cleansing tablet

combination of mechanical and chemical cleaning

first submitted to the mechanical method, followed by the chemical method.

Group Type ACTIVE_COMPARATOR

combination of mechanical and chemical cleaning

Intervention Type OTHER

cleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet

Interventions

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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

Intervention Type OTHER

cleaning removable acrylic appliance with cleansing tablet

chemical cleaning by patient for 7 days with cleansing tablet

Intervention Type OTHER

combination of mechanical and chemical cleaning

cleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet

Intervention Type OTHER

Other Intervention Names

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Denture brush (Foramen denture brush, Spain), CHX toothpaste(Lacalute Active, Germany) cleansing tablet (Lacalute cleansing tablet, Germany) cleaning with brushing then with the cleaning tablet

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Dheaa Hussein Al-Groosh

Prof.Dr Dheaa Hussein Al-Groosh

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dheaa Al-Groosh, Ph.D

Role: STUDY_DIRECTOR

University of Baghdad

Locations

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Baghdad college of dentistry

Baghdad, Bab-Almuadham, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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safa khawwam, B.D.S

Role: CONTACT

Phone: +9647704221054

Email: [email protected]

Dheaa Al-Groosh, Ph.D

Role: CONTACT

Phone: +9647737776503

Email: [email protected]

References

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Albanna RH, Farawanah HM, Aldrees AM. Microbial evaluation of the effectiveness of different methods for cleansing clear orthodontic retainers: A randomized clinical trial. Angle Orthod. 2017 May;87(3):460-465. doi: 10.2319/072916-585.1. Epub 2016 Nov 15.

Reference Type BACKGROUND
PMID: 27845562 (View on PubMed)

Eichenauer J, Serbesis C, Ruf S. Cleaning removable orthodontic appliances: a survey. J Orofac Orthop. 2011 Oct;72(5):389-95. doi: 10.1007/s00056-011-0043-2. English, German.

Reference Type BACKGROUND
PMID: 21990062 (View on PubMed)

Leao RS, Maior JRS, Lemos CAA, Vasconcelos BCDE, Montes MAJR, Pellizzer EP, Moraes SLD. Complications with PMMA compared with other materials used in cranioplasty: a systematic review and meta-analysis. Braz Oral Res. 2018 Jun 7;32:e31. doi: 10.1590/1807-3107bor-2018.vol32.0031.

Reference Type BACKGROUND
PMID: 29898018 (View on PubMed)

Lima EM, Moura JS, Del Bel Cury AA, Garcia RC, Cury JA. Effect of enzymatic and NaOCl treatments on acrylic roughness and on biofilm accumulation. J Oral Rehabil. 2006 May;33(5):356-62. doi: 10.1111/j.1365-2842.2005.01564.x.

Reference Type BACKGROUND
PMID: 16629894 (View on PubMed)

Pathak AK, Sharma DS. Biofilm associated microorganisms on removable oral orthodontic appliances in children in the mixed dentition. J Clin Pediatr Dent. 2013 Spring;37(3):335-9. doi: 10.17796/jcpd.37.3.92230h6256v8697t.

Reference Type BACKGROUND
PMID: 23855182 (View on PubMed)

Puri G, Berzins DW, Dhuru VB, Raj PA, Rambhia SK, Dhir G, Dentino AR. Effect of phosphate group addition on the properties of denture base resins. J Prosthet Dent. 2008 Oct;100(4):302-8. doi: 10.1016/S0022-3913(08)60210-3.

Reference Type BACKGROUND
PMID: 18922259 (View on PubMed)

Rodriguez-Renteria M, Marquez-Preciado R, Ortiz-Magdaleno M, Bermeo-Escalona J, Sanchez-Vargas LO. Frequency of Pathogenic Microorganisms in Removable Orthodontic Appliances and Oral Mucosa in Children. J Clin Pediatr Dent. 2021 Apr 1;45(2):135-139. doi: 10.17796/1053-4625-45.2.11.

Reference Type BACKGROUND
PMID: 33951170 (View on PubMed)

Schwindling FS, Rammelsberg P, Stober T. Effect of chemical disinfection on the surface roughness of hard denture base materials: a systematic literature review. Int J Prosthodont. 2014 May-Jun;27(3):215-25. doi: 10.11607/ijp.3759.

Reference Type BACKGROUND
PMID: 24905261 (View on PubMed)

Xiao J, Moon Y, Li L, Rustchenko E, Wakabayashi H, Zhao X, Feng C, Gill SR, McLaren S, Malmstrom H, Ren Y, Quivey R, Koo H, Kopycka-Kedzierawski DT. Candida albicans Carriage in Children with Severe Early Childhood Caries (S-ECC) and Maternal Relatedness. PLoS One. 2016 Oct 14;11(10):e0164242. doi: 10.1371/journal.pone.0164242. eCollection 2016.

Reference Type BACKGROUND
PMID: 27741258 (View on PubMed)

Khawwam SI, Al-Groosh DH. Effect of Different Cleaning Regimes on Biofilm Formation of Acrylic-Based Removable Orthodontic Appliance: A Randomized Clinical Trial. ScientificWorldJournal. 2023 Oct 12;2023:9920850. doi: 10.1155/2023/9920850. eCollection 2023.

Reference Type DERIVED
PMID: 37868294 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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cleaning of ROA

Identifier Type: -

Identifier Source: org_study_id