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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03930927
Other study ID # 1998
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date May 1, 2019
Est. completion date March 1, 2021

Study information

Verified date April 2019
Source Cairo University
Contact raneen ahmed gohar, Assistant lecturer
Phone (002)01007331552
Email raneen.aboelgheit@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?


Description:

Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.

Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date March 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 22 Years
Eligibility Inclusion Criteria:

- Patients with post orthodontic white spot lesion.

- Patients with good oral hygiene.

- Patients with good general health.

- Cooperative patients.

- Subjects who signed the informed consent.

Exclusion Criteria:

- Patients with tetracycline pigmentation and dental fluorosis.

- Enamel cavitation.

- Disable patient.

- patient with any systemic disease or severe medical complications.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Self Assembling peptide
enamel regeneration
remineralizing agent
enamel regeneration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Raneen Ahmed

Outcome

Type Measure Description Time frame Safety issue
Primary Remineralizing process using DIAGNOpen. 6 months
Secondary Visual assessment using ICDAS II 6 months
See also
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Terminated NCT04827966 - Remineralization Agents for the Treatment of White Spot Lesions N/A
Not yet recruiting NCT03973554 - Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions Phase 2
Completed NCT05757440 - Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions N/A
Completed NCT05871619 - Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions N/A
Not yet recruiting NCT03721198 - RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment N/A
Completed NCT03526276 - Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth N/A
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Completed NCT04401280 - Bioactive Glass in the Treatment of Enamel White Spot Lesions Phase 3
Completed NCT03738839 - A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method N/A
Recruiting NCT04994314 - White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial Phase 3
Completed NCT04992481 - Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients N/A
Active, not recruiting NCT05764187 - Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets N/A
Recruiting NCT03217084 - Treatment of Postorthodontic White Spot Lesions Phase 4
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