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

NCT05707221 | Unknown

• 1 other identifier: cleaning of ROA
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Disease

Keywords

Oral biofilm; Removable Orthodontic appliance; Cleaning Removable appliances

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• microbial evaluation between the polished and unpolished acrylic discs

  7 days

Study Arms (3)

mechanical cleaning method by denture brush and Chlorhexidine toothpaste

ACTIVE COMPARATOR

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

chemical cleaning method with cleaning tablet

ACTIVE COMPARATOR

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

combination of mechanical and chemical cleaning

ACTIVE COMPARATOR

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

Other: combination of mechanical and chemical cleaning

Interventions

cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste OTHER

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

Also known as: Denture brush (Foramen denture brush, Spain), CHX toothpaste(Lacalute Active, Germany)

mechanical cleaning method by denture brush and Chlorhexidine toothpaste

cleaning removable acrylic appliance with cleansing tablet OTHER

chemical cleaning by patient for 7 days with cleansing tablet

Also known as: cleansing tablet (Lacalute cleansing tablet, Germany)

chemical cleaning method with cleaning tablet

combination of mechanical and chemical cleaning OTHER

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

Also known as: cleaning with brushing then with the cleaning tablet

combination of mechanical and chemical cleaning

Eligibility Criteria

• Age: 7 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad college of dentistry

Baghdad, Bab-Almuadham, 10047, Iraq

RECRUITING

Related Publications (10)

• 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.

  PMID: 27845562 BACKGROUND

• 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.

  PMID: 21990062 BACKGROUND

• 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.

  PMID: 29898018 BACKGROUND

• 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.

  PMID: 16629894 BACKGROUND

• 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.

  PMID: 23855182 BACKGROUND

• 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.

  PMID: 18922259 BACKGROUND

• 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.

  PMID: 33951170 BACKGROUND

• 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.

  PMID: 24905261 BACKGROUND

• 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.

  PMID: 27741258 BACKGROUND

• 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.

  PMID: 37868294 DERIVED

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Dheaa Al-Groosh, Ph.D

  University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

safa khawwam, B.D.S

CONTACT

+9647704221054; safa.emad1203a@codental.uobaghdad.edu.iq

Dheaa Al-Groosh, Ph.D

CONTACT

+9647737776503; d.al-groosh@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr Dheaa Hussein Al-Groosh

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 31, 2023
• Study Start: April 17, 2022
• Primary Completion: February 25, 2023
• Study Completion: April 30, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

IR (1)