Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 1:00 AM
Study NCT ID:
NCT04540835
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effectiveness of Calcium Phosphate Containing Desensitizer on Postoperative Sensitivity
Sponsor:
Baskent University
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of Calcium-Phosphate-Containing Desensitizing Agent on Postoperative Sensitivity in Composite Restorations: A Double-Blind Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this randomized clinical study, we aim to evaluate the effects of Teethmate Desensitizer on postoperative sensitivity when applied underneath the composite restoration by comparing it with the negative control group.
Detailed Description:
For the purpose of statistical preliminary analysis, the part related to the comparison of the dependent two sample means (t test) was used in the G \* power 3.1 program. The power of the test was taken as 90%, margin of error 5% and effect size 0.50. The total sample size was found to be 44. In this study, the required number of participants was determined to be at least 44, since the split-mouth technique in which both the experimental and the control groups will be used in each patient, and the number of participants to be included in the study was determined as 50 considering the ''drop-outs'' that may occur during the study. Then, randomization will be achieved using the blocked randomization technique. Randomization will be done on www.sealedenvelope.com website. For blocked randomization, the seed number will be 12345 and the block width will be 2.
After applying to Başkent University Faculty of Dentistry, dental caries are detected as a result of the clinical and radiological examination, and female or male patients will be selected among the ones who are referred to the Restorative Dentistry Department's clinic for treatment. Participation in the study is on a voluntary basis and the participants who accept the invitation will have the Informed Consent Form read and signed. If deemed necessary, the participants will be given oral hygiene motivation and initiatives will be started after their oral hygiene is achieved to a satisfactory level.
Before starting treatment of individuals diagnosed with caries clinically and radiologically, the vitality of the relevant teeth will be measured using a vitalometer (Model D624, Parkell Inc, USA). After the opening of 2 cavities in each participant, the cavities will be isolated, and Teethmate Desensitizer will be applied randomly to one of the two cavities. In order to ensure randomization, the randomization list prepared using the program on www.sealedenvelop.com will be put in an opaque envelope. When the application will be made, the envelope will be opened. Then, CaOH(Dycal, Dentsply, USA) will be placed in the deepest place where the pulp is closest. Restorations will be performed after the matrix system is applied when necessary. All cavities one-step self-etch an adhesive (Clearfil SE Bond, Kuraray Noritake, Tokyo, Japan) LED light applied according to the user instructions (Ledmax Cordless 550 Benlioğlu, Turkey)\> 1,500mw / cm2 for 10 seconds polymerized. The teeth will be restored using an oblique incremental technique with a composite resin (Filtek Z250, 3M Espe, USA). Each layer will be polymerized for 20 sec. Finishing and polishing process will be done using diamond finishing burs, tires and polishing discs (Soflex, 3M Espe, USA). Restoration will be done by a single operator (LK). After the restoration, patients will be given two forms, one for each tooth, where they will record their daily pain levels for a week, and how to register on this form will be explained. These forms given to the participants will include a Numerical Rating Scale (NRS) with scores between 0-4 and a Visual Analogue Scale (VAS) of 0-100mm for 1 week. When patients will be called to the control appointment after a week, the forms in which they score the sensitivity level will be taken back. 6 weeks after the restorations are applied, the patients will be invited to a control appointment and the restorations will be checked. At the first week and sixth week control appointments, the restorations will be evaluated by another physician (KY). At the end of the 6 week, the vitality will be controlled. During the six-week study, patients will be asked not to use any pain medication, and if the participant uses painkillers during the study, the participant will be excluded from the study.
After applying to Başkent University Faculty of Dentistry, dental caries are detected as a result of the clinical and radiological examination, and female or male patients will be selected among the ones who are referred to the Restorative Dentistry Department's clinic for treatment. Participation in the study is on a voluntary basis and the participants who accept the invitation will have the Informed Consent Form read and signed. If deemed necessary, the participants will be given oral hygiene motivation and initiatives will be started after their oral hygiene is achieved to a satisfactory level.
Before starting treatment of individuals diagnosed with caries clinically and radiologically, the vitality of the relevant teeth will be measured using a vitalometer (Model D624, Parkell Inc, USA). After the opening of 2 cavities in each participant, the cavities will be isolated, and Teethmate Desensitizer will be applied randomly to one of the two cavities. In order to ensure randomization, the randomization list prepared using the program on www.sealedenvelop.com will be put in an opaque envelope. When the application will be made, the envelope will be opened. Then, CaOH(Dycal, Dentsply, USA) will be placed in the deepest place where the pulp is closest. Restorations will be performed after the matrix system is applied when necessary. All cavities one-step self-etch an adhesive (Clearfil SE Bond, Kuraray Noritake, Tokyo, Japan) LED light applied according to the user instructions (Ledmax Cordless 550 Benlioğlu, Turkey)\> 1,500mw / cm2 for 10 seconds polymerized. The teeth will be restored using an oblique incremental technique with a composite resin (Filtek Z250, 3M Espe, USA). Each layer will be polymerized for 20 sec. Finishing and polishing process will be done using diamond finishing burs, tires and polishing discs (Soflex, 3M Espe, USA). Restoration will be done by a single operator (LK). After the restoration, patients will be given two forms, one for each tooth, where they will record their daily pain levels for a week, and how to register on this form will be explained. These forms given to the participants will include a Numerical Rating Scale (NRS) with scores between 0-4 and a Visual Analogue Scale (VAS) of 0-100mm for 1 week. When patients will be called to the control appointment after a week, the forms in which they score the sensitivity level will be taken back. 6 weeks after the restorations are applied, the patients will be invited to a control appointment and the restorations will be checked. At the first week and sixth week control appointments, the restorations will be evaluated by another physician (KY). At the end of the 6 week, the vitality will be controlled. During the six-week study, patients will be asked not to use any pain medication, and if the participant uses painkillers during the study, the participant will be excluded from the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: