Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite

NCT05771077 | Completed Phase 1 DMC

• 1 other identifier: Asmaa Khater
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is a common oral disease. The process of caries formation is a cycle of remineralization and demineralization with various stages being either reversible or irreversible.

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Remineralization

  to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer and Nanohydroxy apatite alone or combined on demineralized enamel on White Spot lesion. Remineralization will be assessed by radiodensity using digital radiography

  3 months

Study Arms (1)

patients have White spot lesions

EXPERIMENTAL

White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization, without cavitation. These manifestations represent the first clinical observation of the progression of dental caries, with the possibility of being reversed

Drug: Poly(Amidoamine) dendrimer

Interventions

Poly(Amidoamine) dendrimer DRUG

to evaluate the Remineralizing effect of Poly Amido Amine Dendrimer, Nanohydroxy apatite \& Their Combination on demineralized enamel \& Their Clinical Efficacy on White Spot lesion

Also known as: Nano-hydroxyapatite

patients have White spot lesions

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patients have at least 3 WSLS.
• The patients aged between 16 and 25 years old
• The patients with good general health and no systemic disease.

You may not qualify if:

• Presence of enamel hypoplasia or dental fluorosis.
• Presence of carious cavity.
• Allergy to fluoride gel being used in this stufy
• Patients who have a significant medical history, including pregnancy and breast feeding and smokers.
• Patients who have evidence of reduced salivary flow or significant tooth wear.
• Patients who had participating in concurrent clinical trials or who had recently participated in other clinical trials of an investigational drug or device.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Dentistary - Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Interventions

Poly(amidoamine); Dendrimers; nano-hydroxyapatite-collagen

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Drug Carriers; Drug Delivery Systems; Drug Therapy; Therapeutics; Nanoparticles; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Wael Essam Gamel, Professor

  Al-Azhar Faculty of Dentistary for girls

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 16, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

EG (1)