Trial Outcomes & Findings for Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions (NCT NCT02724592)

Results Overview

Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

70 participants

Primary outcome timeframe

6 months

Results posted on

2021-04-08

Participant Flow

70 patients met the inclusion criteria and offered participation

No patient declined to participate

Participant milestones

Participant milestones
Measure	Intervention intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
Overall Study STARTED	35	35
Overall Study COMPLETED	31	34
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=35 Participants intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control n=35 Participants control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Total n=70 Participants Total of all reporting groups
Age, Continuous	9.0 years n=5 Participants	10.5 years n=7 Participants	9.75 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment Germany	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device. Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity. Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control n=34 Participants control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.	18.6 units on a scale Standard Deviation 19.8	1.1 units on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: 6 months

Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control n=34 Participants control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
Visual Analog Scale of Lesion Progression (VAS)	88.0 units on a scale Standard Deviation 40.8	49.1 units on a scale Standard Deviation 43.8

SECONDARY outcome

Timeframe: 6 months

Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall. This carries clinical index range from 0 to 6. The values mean: 0 No evidence of caries 1. Initial caries 2. Distinct visual change in enamel 3. Localised enamel breakdown due to caries with no visible dentine 4. Underlying dark shadow from dentine 5. Distinct cavity with visible dentine 6. Extensive distinct cavity with visible dentine. During the study, a change from level to lower level number (e.g. from 2 to 1) in patients means that the carious lesion is regressed.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control n=34 Participants control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
ICDAS Classification Index	9 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study. This assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color. During the study, an alteration from active lesion to in active lesion means an improvement.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) self assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions	Control n=34 Participants control group, only Fluoride varnish (Duraphat®) fluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
Caries Activity Assessment According to Nyvad Criteria	6 Participants	21 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohammad Alkilzy

University of Greifswald

Phone: 0049-17623399340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place