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

Oral Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707221
• Other study ID #: cleaning of ROA
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2023
• Source: University of Baghdad
• Contact: safa khawwam, B.D.S
• Phone: +9647704221054
• Email: safa.emad1203a[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: April 30, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Disease

Intervention

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
• cleaning removable acrylic appliance with cleansing tablet
chemical cleaning by patient for 7 days with cleansing tablet
• combination of mechanical and chemical cleaning
cleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet

Locations

Country	Name	City	State
Iraq	Baghdad college of dentistry	Baghdad	Bab-Almuadham

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbial evaluation between the three cleaning methods	numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.	7 days
Secondary	microbial evaluation between the polished and unpolished acrylic discs	numbers of streptococcus species, staphylococcus species and total anaerobic bacteria will be evaluated after isolation from acrylic discs and culture.	7 days