Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions

October 6 University

Status and phase: Enrolling; Early Phase 1

Conditions: White Spot Lesion

Treatments: Drug: P11-4, a self-assembling peptide with flouride; Drug: P11-4, a self-assembling peptide; Drug: resin infilteration

Study type: Interventional

Funder types: Other

Identifiers

NCT06708481

P-PD-24-03

Details and patient eligibility

About

Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions

Full description

Patient/population:

Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.

Intervention:

I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish

Comparator Resin Infiltration

Outcome:

Primary outcome

• Esthetic Improvement of white spot lesion

Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software.

Outcome measuring unit: change in Percentage

• Tooth remineralization

1. Outcome measure: International Caries Detection and Assessment System (ICDAS) score.

   Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6

2. Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99

Secondary outcome

Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy

Outcome measuring Unit :Numerical score from 1-5

Study design: Randomized clinical trial Time: 6 months

Enrollment: 150 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age (a range from 7-14 years of age was determined)
• Good general health (absence of disease/no handicaps, to ensure oral care at home)
• Preserved pulp vitality of the teeth.
• Consolidated oral care daily.
• Agreement by patient and parents (or guardians) to participate in the study

Exclusion criteria

• Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
• Teeth revealing any restorations were excluded from the current study.
• Any previous or planned WSL treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Self-Assembling Peptide (P11-4)

Experimental group

Description:

self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS)

Treatment:

Drug: P11-4, a self-assembling peptide

Self-Assembling Peptide (P11-4) with fluoride varnish

Experimental group

Description:

CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355).

Treatment:

Drug: P11-4, a self-assembling peptide with flouride

Resin Infilteration

Active Comparator group

Description:

ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant

Treatment:

Drug: resin infilteration