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NCT03976583 Clinical Trial

Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions

White Spot Lesion Clinical Trial

Official title:
Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions (Randomized Controlled Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03976583
Other study ID # 1081988
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2019
Est. completion date September 1, 2021

Study information
Verified date June 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.

Description:

The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 62
Est. completion date September 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 25 Years
Eligibility Inclusion Criteria:

- Males or females.

- Age: 12-25 years old.

- Patients with good oral hygiene.

- Co-operative patients who show interest to participate in the study.

Exclusion Criteria:

- Patients with bad oral hygiene.

- Lack of patient's approval and compliance.

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

- Patients who are allergic to milk products.

- Pregnant and lactating women.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cpp-Acp
Remineralising agent
Other:
• Pearl powder
Natural product

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical index used for visual evaluation of white spot lesions Scores(0-No visible colour change, 1-Slight white colour change, only visible after air-drying, 2-Slight colour change with certain marked white areas, 3-White consistent colour change, 4-Distinct white colour change) 12 months
Secondary Digital photographic image analysis Computerised software to analyse the change in the lesion 12 months
See also
  Status Clinical Trial Phase
Completed NCT05710874 - A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding. N/A
Completed NCT04107012 - Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment N/A
Active, not recruiting NCT04342858 - Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment Phase 2
Recruiting NCT05989750 - Air-polishing With Erythritol During Orthodontic Tretament N/A
Completed NCT06200129 - İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin N/A
Not yet recruiting NCT06051981 - White Spot Lesions Treatment in Orthodontic Phase 4
Not yet recruiting NCT04422860 - Remineralization Efficacy of Gum Arabic Varnish. Phase 2/Phase 3
Completed NCT04560478 - Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients N/A
Completed NCT02027922 - Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Groups at High Risk N/A
Completed NCT04908293 - Home Remineralization of White Spot Lesions With Two Different Toothpastes. N/A
Not yet recruiting NCT05868603 - Effect of Different Remineralization Gels N/A
Not yet recruiting NCT06331442 - The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients N/A
Not yet recruiting NCT05306691 - Remineralizing Efficacy of Giomer Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients Early Phase 1
Active, not recruiting NCT06166849 - Clinical Evaluation of an Experimental Remineralization Product N/A
Completed NCT05775250 - Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children N/A
Completed NCT03114475 - Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets N/A
Active, not recruiting NCT06403371 - The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients N/A
Completed NCT05771077 - Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite Phase 1
Completed NCT05721586 - Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth N/A
Completed NCT04671134 - Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study) N/A