Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions

Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Curodont Repair; Device: Fluoride

Detailed Description

All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Sirnach, Thurgau, Switzerland, 8370
      • Zahnheilkunde Seifert Gmbh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Two approximal carious lesions on different teeth with at least one tooth in between
2. Both study lesions must not require an invasive treatment
3. Size and form of the lesions: the lesions must be fully visible and assessable on radiographs

4. The two carious lesions must fall into classes:

   • D2 (inner half of enamel)
   • D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)
5. Able and willing to observe good oral hygiene throughout the study
6. Age ≥ 18 years and ≤ 65 years
7. Willing and able to attend the on-study visits
8. Willing and able to understand all study-related procedures
9. Written informed consent before participation in the study

Exclusion Criteria:

1. The two study test lesions are located on adjacent teeth
2. Fluoride varnish application < 3 months prior to study treatment
3. Tooth with numerous carious lesions
4. Evidence of tooth erosion
5. History of head and neck illnesses (e.g. head/neck cancer)
6. Any pathology or concomitant medication affecting salivary flow or dry mouth
7. Any metabolic disorders affecting bone turnover
8. Patient suffers from diabetes
9. Concurrent participation in another clinical trial
10. Women who are breast-feeding, pregnant or who plan a pregnancy during the study
11. Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curodont Repair; Application on Day 0 and Day 360	Device: Curodont Repair; Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360; Other Names: P11-4
Active Comparator: Fluoride; Application on Day 0, Day 180, Day 360, Day 540	Device: Fluoride; Application on Day 0, Day 180, Day 360, Day 540; Other Names: Duraphat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opaqueness on X-Ray	The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group.	Day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional benefit of a second Curodont Repair application	The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group.	Day 720

Collaborators and Investigators

• Sponsor: Credentis AG
• Investigators: Principal Investigator: Mathias Seifert, Med. dent., Zahnheilkunde Seifert Gmbh

Publications and helpful links

General Publications

• Brunton PA, Davies RP, Burke JL, Smith A, Aggeli A, Brookes SJ, Kirkham J. Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial. Br Dent J. 2013 Aug;215(4):E6. doi: 10.1038/sj.bdj.2013.741.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 26, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Dental caries; Curodont Repair; P11-4
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: P11-4-RACL