NCT00254345

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 11, 2007

Status Verified

December 1, 2007

First QC Date

November 15, 2005

Last Update Submit

December 10, 2007

Conditions

Keywords

biofilmadhesionliquid polishbonding resinPMMA Polymethylmetacrylateprovisional crownno antibiotics treatment three months prior to experimentno mouth rinse with oral solutions one month prior to experiment

Outcome Measures

Primary Outcomes (1)

  • surface coating with reduced biofilm formation demonstrated by confocal scanning laser microscope and scanning electron microscope

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient in need for PMAA provisional crowns

You may not qualify if:

  • Patient took antibiotics three months prior to experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Dental PlaqueTissue Adhesions

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael M Perez Davidi, DMD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 16, 2005

Study Start

September 1, 2006

Study Completion

April 1, 2007

Last Updated

December 11, 2007

Record last verified: 2007-12

Locations