Clinical trial NCT02119507: Effect of Curodont Repair in Patients With Early Approximal Carious Lesions
Official title: Effect of Curodont Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Post-marketing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Curodont Repair
P11-4
Lead sponsor: Credentis AG
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.

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 the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.

Eligibility criteria: Inclusion Criteria:

* Two approximal carious lesions on different teeth with at least one tooth in between
* Both study lesions must not require an invasive treatment
* Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
* The two carious lesions must fall into classes:

D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)

* Able and willing to observe good oral hygiene throughout the study
* Age ≥ 18 years and ≤ 65 years
* Willing and able to attend the on-study visits
* Willing and able to understand all study-related procedures
* Written informed consent before participation in the study

Exclusion Criteria:

* The two study test lesions are located on adjacent teeth
* Fluoride varnish application \< 3 months prior to study treatment
* Tooth with numerous carious lesions
* Evidence of tooth erosion
* 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
* Patient suffers from diabetes
* Concurrent participation in another clinical trial
* Women who are breast-feeding, pregnant or who plan a pregnancy during the study
* 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

Primary outcomes:
measure: Opaqueness on X-Ray
timeFrame: Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Zumstein Dental Clinic Ag
Study officials:
affiliation: zumstein dental clinic ag
name: Rolf Heimlinger, Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.