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

University Medicine Greifswald

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dental Caries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02724592

BB001/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

intervention

Experimental group

Description:

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

Treatment:

Device: self assembling peptide P11-4 (Curodont™ Repair)

Device: fluoride varnish (Duraphat®)

control

Active Comparator group

Description:

control group, only Fluoride varnish (Duraphat®)

Treatment:

Device: fluoride varnish (Duraphat®)