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

NCT ID: NCT02724592

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-10-31

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.

Detailed 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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention

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

Group Type: EXPERIMENTAL

self assembling peptide P11-4 (Curodont™ Repair)

Intervention Type: DEVICE

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

fluoride varnish (Duraphat®)

Intervention Type: DEVICE

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

control

control group, only Fluoride varnish (Duraphat®)

Group Type: ACTIVE_COMPARATOR

fluoride varnish (Duraphat®)

Intervention Type: DEVICE

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

Interventions

self assembling peptide P11-4 (Curodont™ Repair)

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

Intervention Type: DEVICE

fluoride varnish (Duraphat®)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Alkilzy, Dr. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Greifswald

References

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.

Reference Type: DERIVED

PMID: 28892645 (View on PubMed)

Other Identifiers

BB001/13

Identifier Type: -

Identifier Source: org_study_id