Clinical trial NCT06855940: Evaluation of Tooth Sensitivity and Whitening Effects of Different Content Teeth Whitening Agents
Official title: Evaluation of the Tooth Sensitivity and Whitening Effects of Calcium, Hydroxyapatite and Fluoride Containing Tooth Whitening Agents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Discoloration of Teeth
Bleaching Sensitivity
Keywords: Bleaching Agents
Bleaching agent \( BOOST 40%\)
Bleaching teeth
Discoloration of Teeth
Sensitivity, Tooth
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
name: Scientific Research Projects
First posted: 2025-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: X bleaching agents Group B: Y bleaching agents Group C: Z bleaching agents
Primary purpose: TREATMENT

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

Detailed description: The participants in the study were healthy volunteers between the ages of 18-50. The number of volunteers was determined by using other studies similar to this study. There are 60 volunteers in three groups, 20 volunteers in each group. A different whitening agent is applied to each group by the researcher.

The researcher did not include volunteers with poor oral hygiene, smoking, tooth sensitivity, caries, or medication use in the study.

The researcher began the study by performing color measurement and sensitivity assessment before the procedure. Then he applied the whitening agent. The volunteers who underwent the whitening procedure will be evaluated in terms of both color measurements and sensitivity changes at the end of the treatment, 1st week, 2nd week, 1st month, 2nd month, 4th month, 6th month, and 1st year control sessions.

Each patient has their own evaluation form. There are different fields for both color and sensitivity in the form according to the control dates. All numerical data are recorded in their own fields.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in tooth color within 1 year after whitening
timeFrame: through study completion, an average of 1 year
measure: Change in tooth sensitivity after whitening within 1 year
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
References:
citation: Matis BA. Tray whitening: what the evidence shows. Compend Contin Educ Dent. 2003 Apr;24(4A):354-62.
citation: 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.
citation: 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.