Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study
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.


Options:
A: Inclusion Criteria:

- Children aged 3-8 years who attend the Preventive and Paediatric Department of Greifswald University, Germany.

(Lithuania: children who attend the paediatric dentistry department, Dental Faculty, Lithuanian University of Health Sciences)

* At least one primary molar tooth with caries into dentine involving two dental surfaces (diagnosed according to the International Caries Detection and Assessment System \[ICDAS\], codes 3 to 5)
* Willing to be examined

Exclusion Criteria:

* Clinical or radiographic signs of pulpal or peri-radicular pathology
* Patients with a systemic disease requiring special considerations during their dental treatment.
* Parents/children who refuse to participate in the study
B: Inclusion Criteria:

* Any primary school in New York City with a Hispanic/Latino student population greater than 50% and,
* A low-income population (defined as a student receiving free or reduced price lunch) of at least 80%.
* Within participating schools, all children are eligible to participate in the study.

Exclusion Criteria:

* Schools that already have a pre-existing school-based dental health program.
* Within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.
C: Inclusion Criteria:

* Children 3-9 yr
* Good general health
* Minimum one active deep (D3) occlusal/occlusal-proximal, one-/two-surface caries lesion

Exclusion Criteria:

* Participating in other study
* Plan to move or not resident
* Systemic disease or general disability
* Expected limited compliance
* Known allergy to study material expected exfoliation within 18 month
D: 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

Answer: D