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Trial record 34 of 1201 for:    tooth decay

Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions

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ClinicalTrials.gov Identifier: NCT02724592
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:

Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.


Condition or disease Intervention/treatment Phase
Dental Caries Device: self assembling peptide P11-4 (Curodont™ Repair) Device: fluoride varnish (Duraphat®) Phase 2

Detailed Description:

Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study
Study Start Date : February 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: intervention
intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)
Device: self assembling peptide P11-4 (Curodont™ Repair)
Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions

Device: fluoride varnish (Duraphat®)
Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions

Active Comparator: control
control group, only Fluoride varnish (Duraphat®)
Device: fluoride varnish (Duraphat®)
Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions




Primary Outcome Measures :
  1. ICDAS (International Caries Detection and Assessment System) index, caries activity assessment according to Nyvad criteria and LASER fluorescence readings using Diagnodent® device. [ Time Frame: 6 months ]
    Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using ICDAS caries index, caries activity assessment according to Nyvad criteria and LASER fluorescence readings using Diagnodent® device.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (definitions are adapted from Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42). [ Time Frame: 6 months ]
    Safety definitions are adapted from the Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42.

  2. clinical applicability [ Time Frame: 6 months ]
    clinical applicability was investigated using dentist's questionnaire.

  3. patient satisfaction [ Time Frame: 6 months ]
    patient satisfaction was investigated using patient's questionnaire.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
  • Age ≥ 5 years
  • Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
  • Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
  • Written informed consent before participation in the study

Exclusion Criteria:

  • Evidence of tooth erosion
  • Fluoride varnish application < 3 months prior to study treatment
  • History of head and neck illnesses (e.g. head/neck cancer)
  • Any pathology or concomitant medication affecting salivary flow or dry mouth
  • Any metabolic disorders affecting bone turnover
  • Concurrent participation in another clinical trial

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): NCT02724592


Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Principal Investigator: Mohammad Alkilzy, Dr. PhD Humboldt-Universität zu Berlin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02724592     History of Changes
Other Study ID Numbers: BB001/13
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Sodium fluoride topical preparation
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents