Lesion Progression of Approximal Caries After Resin Infiltration

NCT02191943 | Withdrawn

• 1 other identifier: CHARM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Caries

Keywords

caries; proximal; non-cavitated; fluoridation

Outcome Measures

Primary Outcomes (1)

• progression of non-cavitated proximal caries lesions

  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

  up to 36 months

Study Arms (2)

Control (fluoride varnish)

ACTIVE COMPARATOR

Device: Duraphat

resin infiltration (Icon)

EXPERIMENTAL

Device: Icon approximal caries infiltration kit

Interventions

Duraphat DEVICE

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.

Also known as: fluoride varnish

Control (fluoride varnish)

Icon approximal caries infiltration kit DEVICE

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:

Also known as: resin infiltration

resin infiltration (Icon)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead
• Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Jack L Ferracane, Prof.

  OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 16, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: January 26, 2015

Record last verified: 2014-07

Locations

US (1)