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Trial record 82 of 292 for:    Sodium Fluoride OR Duraphat

Lesion Progression of Approximal Caries After Resin Infiltration

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ClinicalTrials.gov Identifier: NCT02191943
Recruitment Status : Withdrawn
First Posted : July 16, 2014
Last Update Posted : January 26, 2015
Sponsor:
Collaborators:
Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover
Oregon Health and Science University
Information provided by (Responsible Party):
DMG Dental Material Gesellschaft mbH

Brief Summary:

The aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression.

Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard preventive treatments.

In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at each institution are to be treated with both, the infiltration technique and using conventional fluoridation treatment in different sides of the mouth ("split-mouth design").

The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration to prevent the progression of existing approximal carious lesions, and thereby enable an improvement in caries prevention within the scope of dental treatment.


Condition or disease Intervention/treatment Phase
Proximal Caries Device: Duraphat Device: Icon approximal caries infiltration kit Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride

Arm Intervention/treatment
Active Comparator: Control (fluoride varnish) Device: Duraphat
The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.
Other Name: fluoride varnish

Experimental: resin infiltration (Icon) Device: Icon approximal caries infiltration kit
Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:
Other Name: resin infiltration




Primary Outcome Measures :
  1. progression of non-cavitated proximal caries lesions [ Time Frame: up to 36 months ]
    preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years and older
  • Good general health
  • At least 2 active, approximal caries lesions present without evidence of frank cavitation Caries depth: E2 - D1 (minimum extension to the inner half of the enamel and maximum to the outer third of the dentin)
  • The posterior teeth on the upper and lower arches from distal of the first premolar to mesial of the second molar will be included
  • All teeth to be treated must have approximal contacts with the adjacent teeth in the arch
  • Other teeth requiring treatment will be treated prior to the beginning of the trial
  • The patients must declare their consent to participate in the clinical trial following the provision of the required clarifications regarding the method, significance and scope of the trial as well as the associated risks. They may withdraw this consent at any time.
  • Participation in the follow-up examinations

Exclusion Criteria:

  • - Parallel participation in a further trial relating to dental materials
  • The patient has not signed the participant consent form
  • Pregnant and breastfeeding women prior to the trial commencing A woman that becomes pregnant after the treatment has been performed will remain in the study, unless she becomes pregnant for a second time in which case, she will be excluded from the study
  • Unexplained diseases of the mucous membranes or conditions in the sense of contact allergies to materials used, e.g. oral lichenoid lesions
  • Known allergies to ingredients contained within the treatment materials used
  • Infectious diseases such as HIV, hepatitis, etc
  • Undergoing orthodontic treatment at the time of the trial
  • Persons who are presently taking other medication due to other illnesses, which upon our examination are deemed to possibly be a risk or a problem for the patient or the study
  • A large number of existing carious lesions that have not been restored and would require extensive treatment, comprehensive prosthetic restorations that need to be done or replaced and severe periodontal disease
  • Current use of bleaching products or use within the two weeks previous to the start of the study
  • No assured dry isolation possible as required per the criteria of the adhesive technology (rubber dam system)
  • Persons with a history of allergies
  • Patients with dental treatment phobias

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191943


Locations
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United States, Oregon
OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)
Portland, Oregon, United States, 97239
Sponsors and Collaborators
DMG Dental Material Gesellschaft mbH
Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover
Oregon Health and Science University
Investigators
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Principal Investigator: Silke Jacker-Guhr, Dr. Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
Principal Investigator: Anne-Kathrin Lührs, Dr. Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
Study Chair: Jack L Ferracane, Prof. OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)

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Responsible Party: DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier: NCT02191943     History of Changes
Other Study ID Numbers: CHARM
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: July 2014
Keywords provided by DMG Dental Material Gesellschaft mbH:
caries
proximal
non-cavitated
fluoridation
Additional relevant MeSH terms:
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Listerine
Fluorides
Fluorides, Topical
Sodium fluoride topical preparation
Sodium Fluoride
Disease Progression
Disease Attributes
Pathologic Processes
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents