Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions

Cairo University (CU)

Status: Unknown

Conditions: Remineralization

Treatments: Drug: Tricalcium phosphate fluoride varnish, 5% F-; Drug: Monomeric self - assembling peptide P11-4; Drug: fluoride varnish (5% sodium fluoride)

Study type: Interventional

Funder types: Other

Identifiers

NCT05064137

257

Details and patient eligibility

About

The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apparently healthy cooperative children
• Aging from 3-5 years old child
• Both genders
• Primary teeth with active WSLs on buccal or labial surfaces
• Patient and parent acceptance to treatment and maintenance of good oral hygiene

Exclusion criteria

• Restored teeth
• White spot lesions due to fluorosis
• Teeth with hypoplasia
• Lesions that require an invasive treatment
• Any pathology or concomitant medication affecting salivary flow or causing dry mouth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Curodont Repair® ( monomeric self - assembling peptide P11-4 )

Experimental group

Description:

Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals.

Treatment:

Drug: Monomeric self - assembling peptide P11-4

Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )

Experimental group

Description:

Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp.

Treatment:

Drug: Tricalcium phosphate fluoride varnish, 5% F-

Voco-profluorid® fluoride varnish (5% sodium fluoride)

Active Comparator group

Description:

Fluoride varnish is the gold standard for treating WSLs.

Treatment:

Drug: fluoride varnish (5% sodium fluoride)