NCT06855940

Brief Summary

The goal of this clinical study is to evaluate the success of different whitening agents in whitening teeth in healthy volunteers aged 18-50. Also, patients' tooth sensitivity will be assessed after application. The main questions it aims to answer are: Is the teeth whitening success of different whitening agents similar? Did participants develop tooth sensitivity to whitening agents? The researchers will compare the whitening success of 3 different whitening agents and changes in tooth sensitivity within 1 year after application. Participants: Whitening agent will be applied in the clinic Visit our clinic for checkups and records after 1 week, 2 weeks, 1 month, 2 months, 4 months , 6 months and 1 year after application

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

February 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

February 25, 2025

Last Update Submit

March 1, 2025

Conditions

Healthy VolunteersDiscoloration of TeethBleaching Sensitivity

Keywords

Bleaching AgentsBleaching agent \( BOOST 40%\)Bleaching teethDiscoloration of TeethSensitivity, Tooth

Outcome Measures

Primary Outcomes (2)

  • Change in tooth color within 1 year after whitening

    Measurement and recording of numerical values of tooth color with vita easyshade device

    through study completion, an average of 1 year

  • Change in tooth sensitivity after whitening within 1 year

    Numerical measurement of sensitivity after bleaching with VAS (visual analog scale)

    through study completion, an average of 1 year

Study Arms (3)

Group A

ACTIVE COMPARATOR

20 random patients( Whitening agent containing fluoride and 40% active ingredients)

Other: Bleaching Agents

Group B

ACTIVE COMPARATOR

20 random patients(Whitening agent containing calcium and 35% active ingredients)

Other: Bleaching Agents

Group C

ACTIVE COMPARATOR

20 random patients(Whitening agent containing hydroxyapatite and 18% active ingredients)

Other: Bleaching Agents

Interventions

Bleaching AgentsOTHER

whitening agent containing fluoride and 40% hydrogen peroxide

Group A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Vital teeth
  • Healthy gums
  • No tooth sensitivity
  • External discoloration ( tea,coffee..)
  • Good oral hygiene
  • No allergy to the material to be used

You may not qualify if:

  • Decayed and devital teeth
  • Presence of gingival bleeding
  • History of trauma
  • Presence of fractures, cracks and aesthetic restoration
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38000, Turkey (Türkiye)

Location

Related Publications (3)

  • Matis BA. Tray whitening: what the evidence shows. Compend Contin Educ Dent. 2003 Apr;24(4A):354-62.

    PMID: 12793212RESULT

  • Meireles SS, Heckmann SS, Santos IS, Della Bona A, Demarco FF. A double blind randomized clinical trial of at-home tooth bleaching using two carbamide peroxide concentrations: 6-month follow-up. J Dent. 2008 Nov;36(11):878-84. doi: 10.1016/j.jdent.2008.07.002. Epub 2008 Aug 22.

    PMID: 18722039RESULT

  • Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients' acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent. 2005 Mar-Apr;30(2):156-63.

    PMID: 15853099RESULT

MeSH Terms

Conditions

Tooth DiscolorationDentin Sensitivity

Interventions

Bleaching Agents

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OxidantsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A: X bleaching agents Group B: Y bleaching agents Group C: Z bleaching agents
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 4, 2025

Study Start

February 2, 2024

Primary Completion

September 13, 2024

Study Completion

October 13, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The work is not yet complete

Locations

TU(1)