Health TrialsbyHealthPanel

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

ConditionWhite Spot Lesion
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age7-14
SponsorOctober 6 University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • P11-4, a self-assembling peptide

    Drug

    rationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues

  • P11-4, a self-assembling peptide with flouride

    Drug

    self assembling peptide with 500 ppm sodium fluoride

  • resin infilteration

    Drug

    Improvement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Self-Assembling Peptide (P11-4)Experimental treatment 1 intervention
Group B: Self-Assembling Peptide (P11-4) with fluoride varnishExperimental treatment 1 intervention
Group C: Resin InfilterationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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: Percentage change

Time frame
6 months
2

Tooth remineralization

ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99

Time frame
6 months

Secondary outcomes

1

Patient Satisfaction

Likert 5-point faces scale ranging from very sad to very happy

Time frame
6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

October 6 UniversityRecruiting Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

October 6 University

Lead sponsor

Al-Azhar University

Collaborator

University of Science and Technology of Fujairah

Collaborator

Source ClinicalTrials.gov
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