Evaluation of the Tooth Sensitivity and Whitening Effects of Calcium, Hydroxyapatite and Fluoride Containing Tooth Whitening Agents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in tooth color within 1 year after whitening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group A
20 random patients( Whitening agent containing fluoride and 40% active ingredients)
Intervention: Bleaching Agents (Other)
Group B
20 random patients(Whitening agent containing calcium and 35% active ingredients)
Intervention: Bleaching Agents (Other)
Group C
20 random patients(Whitening agent containing hydroxyapatite and 18% active ingredients)
Intervention: Bleaching Agents (Other)
Outcomes
Primary Outcomes
Change in tooth color within 1 year after whitening
Time Frame: through study completion, an average of 1 year
Measurement and recording of numerical values of tooth color with vita easyshade device
Change in tooth sensitivity after whitening within 1 year
Time Frame: through study completion, an average of 1 year
Numerical measurement of sensitivity after bleaching with VAS (visual analog scale)
Secondary Outcomes
No secondary outcomes reported
Investigators
Betül Tokat
research assistant
TC Erciyes University