NCT02724592

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
5 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 7, 2016

Results QC Date

February 27, 2017

Last Update Submit

March 15, 2021

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.

    Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.

    6 months

Secondary Outcomes (3)

  • Visual Analog Scale of Lesion Progression (VAS)

    6 months

  • ICDAS Classification Index

    6 months

  • Caries Activity Assessment According to Nyvad Criteria

    6 months

Study Arms (2)

intervention

EXPERIMENTAL

intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)

Device: self assembling peptide P11-4 (Curodont™ Repair)Device: fluoride varnish (Duraphat®)

control

ACTIVE COMPARATOR

control group, only Fluoride varnish (Duraphat®)

Device: fluoride varnish (Duraphat®)

Interventions

self assembling peptide P11-4 (Curodont™ Repair)DEVICE

Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions

intervention
fluoride varnish (Duraphat®)DEVICE

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

controlintervention

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.

    PMID: 28892645DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Mohammad Alkilzy
Organization
University of Greifswald
alkilzym@uni-greifswald.de
0049-17623399340

Study Officials

  • Mohammad Alkilzy, Dr. PhD

    University of Greifswald

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 31, 2016

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share