NCT06782087

Brief Summary

The growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile. The discoloration of teeth might be intrinsic, extrinsic, or combined. A variety of commercial bleaching agents is available. The most common substances used are carbamide peroxide or hydrogen peroxide or a mixture of sodium perborate and hydrogen peroxide.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

September 25, 2025

Status Verified

May 1, 2025

Enrollment Period

15 days

First QC Date

December 23, 2024

Last Update Submit

September 24, 2025

Conditions

Tooth Discoloration

Keywords

chitosan nanoparticlesDiode lasercarbamide peroxidenonvital teeth bleaching

Outcome Measures

Primary Outcomes (2)

  • Color change

    these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade obtaining difference ∆E\* values using colorcoordinates CIE L\*, a\* and b\*

    these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade.

  • color change using digital vita easy shade guide

    color change using digital vita easy shade guide

    1 day , 1 week , 1 month

Study Arms (1)

peroxides and sodium perborate and 980nm diode laser.

OTHER

peroxides and sodium perborate + 980nm diode laser.

Drug: nano chitosan

Interventions

nano chitosanDRUG

nano chitosan

peroxides and sodium perborate and 980nm diode laser.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • discolored crown, non-vital or endodontically treated upper central and lateral incisors
  • previous endodontic treatment performed two or more years earlier.

You may not qualify if:

  • caries on upper central and lateral incisors, inadequate fillings, and progressive periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for science and technology

Giza, Egypt, 41211, Egypt

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Manal abd el baky A dr, phd

    Lecturer in conservative surgery departement

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of conservative dentidtry

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 17, 2025

Study Start

October 15, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

September 25, 2025

Record last verified: 2025-05

Locations

EG(1)