Dental PlaquePhase 1NCT00254345
Effect of Provisional-Crown Surface Coating on Biofilm Formation
A Phase 1 study testing coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin in people with Dental Plaque, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient in need for PMAA provisional crowns
Who cannot join
- Patient took antibiotics three months prior to experiment
Trial locations and contacts
1 site in 1 country.
About this study
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized.
One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported.
Read the detailed description
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized.
One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.
The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported. In this study we intend to measure, in vivo early biofilm formation on PMMA PRs with and without resin coatings.
- Conditions
- Dental Plaque
- Being tested
- coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin
- Keywords
- biofilm, adhesion, liquid polish, bonding resin, PMMA Polymethylmetacrylate, provisional crown, no antibiotics treatment three months prior to experiment, no mouth rinse with oral solutions one month prior to experiment
- Medical subject headings
- Dental Plaque, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coating a dental restoration material ,polymethylmethacrylate, with liquid polish resinProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael M Perez Davidi, DMD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254345
- Sponsor's protocol ID
- 191056HMO-CTIL
- Status last verified
- Dec 2007
- First submitted
- 15 Nov 2005
- Last updated
- 11 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez Davidi M, Beyth N, Sterer N, Feuerstein O, Weiss EI. Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations: part 1. Quintessence Int. 2007 Jul-Aug;38(7):591-6.
PubMed 17694216
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Provisional-Crown Surface Coating on Biofilm Formation
- ClinicalTrials.gov ID
- NCT00254345
- Acronym / sponsor ID
- 191056HMO-CTIL
- Conditions
- Dental Plaque
- Keywords
- biofilm, adhesion, liquid polish, bonding resin, PMMA Polymethylmetacrylate, provisional crown, no antibiotics treatment three months prior to experiment, no mouth rinse with oral solutions one month prior to experiment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Nov 2005 (estimated)
- 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.
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized.
One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported.
Detailed description
Auto polymerizing poly methyl methacrylate (PMMA), and light initiated resin modified PMMAs, are commonly used for fabricating provisional restorations (PRs) during prosthetic treatment 1. Biofilm accumulated on these PRs may cause caries and inflammation of the surrounding tissue, tempering the outcome of the final restoration 2. Plaque adherence to temporary restorations was significantly increased compared with the untreated reference teeth 3. Biologic and physical properties of the various materials used as PRs were studied extensively 4-8 whereas their interaction with bacterial biofilm in vivo and ex vivo is less characterized.
One improvement in provisional restorative materials is the use of liquid polish. It is claimed that these materials gives a high luster finish to provisional bis-acryl restorations and processed acrylic appliances, reduces or eliminates costly and time consuming polishing steps and can be used on all types of direct and indirect restorations and appliances.
The effect of liquid polish coating or resin bonding coating on biofilm formation on PRs was not reported. In this study we intend to measure, in vivo early biofilm formation on PMMA PRs with and without resin coatings.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient in need for PMAA provisional crowns
Key exclusion criteria (1 listed)
- Patient took antibiotics three months prior to experiment
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 |
|---|---|---|
| coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin | Procedure or surgery | – |
Primary outcome
surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2007.
- Results publication: PubMed 17694216Perez Davidi M, Beyth N, Sterer N, Feuerstein O, Weiss EI. Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations: part 1. Quintessence Int. 2007 Jul-Aug;38(7):591-6.
- Michael Perez DavidiLink provided by the sponsor.
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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.
Michael M Perez Davidi, DMD study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing coating a dental restoration material ,polymethylmethacrylate, with liquid polish resin in people with Dental Plaque, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2007. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope. 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 NCT00254345, which also lists 1 linked publication.
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 11 Dec 2007.