Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

White Spot Lesion Clinical Trial

Official title:

Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04245787
• Other study ID #: p11 4
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: omnia amin, master
• Phone: 01272512839
• Email: omniaamin232[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .

Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 and 35 years of age female and males

• Had received conventional periodontal therapy

• Active carious white spot lesions

• No systemic diseases or concomitant medication affecting salivary flow

Exclusion Criteria:

• - Participant in another trial

• Non carious lesion (enamel hypoplasia and dental flourosis)

• Presence of abnormal oral, medical, or mental condition.

• Participants who had evidence of reduced salivary flow or significant tooth wear.

• Allergy to MI paste

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Drug:
• Self assembling peptide with fluoride
peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration

Locations

Country	Name	City	State
Egypt	Faculty Of Oral & Dental Medicine - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remineralization potential	by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: First visual change in enamel.; Distinct visual change in enamel visible when wet, lesion must be visible when dry.	T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(
Secondary	Remineralization potential	by: Image analysis software Change in area of the white spot lesion (mm2)	T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres