Oral DiseaseNCT05707221
Effect of Different Cleaning Regimes on Biofilm Formation of Acrylic Based Removable Orthodontic Appliance
A study testing cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste, cleaning removable acrylic appliance with cleansing tablet and combination of mechanical and chemical cleaning in people with Oral Disease, run by University of Baghdad at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 7 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Disease
- What is being tested?
- cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste, cleaning removable acrylic appliance with cleansing tablet and combination of mechanical and chemical cleaning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIraq
- Study dates
- 17 Apr 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Participant taking steroid-based or antibacterial mouthwash or broad-spectrum antibiotics
- Mouth breather
- Participant taking medication that reduces salivary flow
- Pregnant lactating female
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Baghdad college of dentistry
Baghdad, Bab-Almuadham, 10047
About this study
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.
Read the 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
- Conditions
- Oral Disease
- Being tested
- cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste, cleaning removable acrylic appliance with cleansing tablet, combination of mechanical and chemical cleaning
- Keywords
- Oral biofilm, Removable Orthodontic appliance, Cleaning Removable appliances
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleaning removable acrylic appliance with denture brush and chlorhexidine toothpasteOther
Also called Denture brush (Foramen denture brush, Spain), CHX toothpaste(Lacalute Active, Germany)
mechanical cleaning of removable appliance by the patient for 7 days before bedtime for one minute
cleaning removable acrylic appliance with cleansing tabletOther
Also called cleansing tablet (Lacalute cleansing tablet, Germany)
chemical cleaning by patient for 7 days with cleansing tablet
combination of mechanical and chemical cleaningOther
Also called cleaning with brushing then with the cleaning tablet
cleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: combination of mechanical and chemical cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start17 Apr 2022
- Primary completion25 Feb 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dheaa Hussein Al-Groosh, University of Baghdad
- Investigators
- Dheaa Al-Groosh, Ph.D, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707221
- Sponsor's protocol ID
- cleaning of ROA
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27845562Eichenauer 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.
PubMed 21990062Leao 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.
PubMed 29898018Lima 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.
PubMed 16629894Pathak 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.
PubMed 23855182Puri 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.
PubMed 18922259Rodriguez-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.
PubMed 33951170Schwindling 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.
PubMed 24905261Xiao 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.
PubMed 27741258Khawwam 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.
PubMed 37868294
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Cleaning Regimes on Biofilm Formation of Acrylic Based Removable Orthodontic Appliance
- ClinicalTrials.gov ID
- NCT05707221
- Acronym / sponsor ID
- cleaning of ROA
- Conditions
- Oral Disease
- Keywords
- Oral biofilm, Removable Orthodontic appliance, Cleaning Removable appliances
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 25 Feb 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| mechanical cleaning method by denture brush and Chlorhexidine toothpaste | Active comparator | Other: cleaning removable acrylic appliance with denture brush and chlorhexidine toothpastepatients 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 |
| chemical cleaning method with cleaning tablet | Active comparator | Other: cleaning removable acrylic appliance with cleansing tabletpatients 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. |
| combination of mechanical and chemical cleaning | Active comparator | Other: combination of mechanical and chemical cleaningfirst submitted to the mechanical method, followed by the chemical method. |
Who may qualify
- Ages
- 7 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Participant taking steroid-based or antibacterial mouthwash or broad-spectrum antibiotics
- Mouth breather
- Participant taking medication that reduces salivary flow
- Pregnant lactating female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cleaning removable acrylic appliance with denture brush and chlorhexidine toothpasteAlso: Denture brush (Foramen denture brush, Spain), CHX toothpaste(Lacalute Active, Germany)mechanical cleaning of removable appliance by the patient for 7 days before bedtime for one minute | Other | mechanical cleaning method by denture brush and Chlorhexidine toothpaste |
| cleaning removable acrylic appliance with cleansing tabletAlso: cleansing tablet (Lacalute cleansing tablet, Germany)chemical cleaning by patient for 7 days with cleansing tablet | Other | chemical cleaning method with cleaning tablet |
| combination of mechanical and chemical cleaningAlso: cleaning with brushing then with the cleaning tabletcleaning the appliance with denture brush and CHX toothpaste followed by the cleansing tablet | Other | combination of mechanical and chemical cleaning |
Primary outcome
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.
1 secondary outcome
microbial evaluation between the polished and unpolished acrylic discs
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 27845562Albanna 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.
- Background: PubMed 21990062Eichenauer 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.
- Background: PubMed 29898018Leao 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.
- Background: PubMed 16629894Lima 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.
- Background: PubMed 23855182Pathak 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.
- Background: PubMed 18922259Puri 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.
- Background: PubMed 33951170Rodriguez-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.
- Background: PubMed 24905261Schwindling 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.
- Background: PubMed 27741258Xiao 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.
- Derived from this study: PubMed 37868294Khawwam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheaa Al-Groosh, Ph.D study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cleaning removable acrylic appliance with denture brush and chlorhexidine toothpaste, cleaning removable acrylic appliance with cleansing tablet and combination of mechanical and chemical cleaning in people with Oral Disease, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact safa khawwam, B.D.S (+9647704221054 ext. +964, safa.emad1203a@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbial evaluation between the three cleaning methods (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707221, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.