Clinical trial NCT06708481: Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions
Official title: Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: White Spot Lesion
Keywords: Resin Infilteration , white spot lesions , Self assembling peptide, remineralization
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
name: University of Science and Technology of Fujairah
First posted: 2024-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Esthetic Improvement of white spot lesion
timeFrame: 6 months
measure: Tooth remineralization
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
state: Giza
Study officials:
References: