Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teethmate | Experimental | Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration |
|
| Negative Control | No Intervention | Half of the cavities will be restored without application of Teethmate Desensitizer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teethmate Desensitizer (Kuraray) | Device | Calcium phosphate desensitizer applied after caries removal. After restored using an oblique incremental technique with a composite resin (Filtek Z250, 3M Espe, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Postoperative hypersensitivity was evaluated using a 10-cm Visual Analogue Scale (VAS). The scale consisted of a straight 10-cm line with endpoints defining extreme limits: "no pain at all" (score = 0) and "pain as bad as it could be" (score = 10). Participants were asked to mark their perceived pain level on the line between the two endpoints. The distance (in cm) from the "no pain" end to the mark represented the participant's pain score. Higher scores indicated greater hypersensitivity (worse outcome). | 7 days after restoration |
| Numerical Rating Scale (NRS) | Progress of postoperative hypersensitivity will be also evaluated by using Numerical Rating Scale with five possibilities for the patient to state how much sensitivity there is in each tooth. The patients will have the option of saying whether the sensitivity was equal to 0 (none), 1 (mild), 2 (moderate), 3 (considerable), or 4 (severe). The mean and standard deviation (SD) of NRS scores were calculated for each group. | 7 days after restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Postoperative Hypersensitivity (Patient-reported at 6 Weeks) | This patient-reported outcome was pre-specified in the study protocol to assess the presence of postoperative hypersensitivity at 6 weeks. | 6 weeks after restoration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leyla Kerimova, DDS | Baskent University School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Ankara | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Since the study was designed as split-mouth, each participant had 2 restorations (experimental and control group) . The study groups allocated according to randomisation list created in www.sealedenvelope.com |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 |
|
| ||||||||||||||||||||||||
| Week 6 |
|
The baseline analysis included participants whose treated teeth responded positively to the electric pulp test. Each participant was examined intraorally using an electric pulp tester, and only teeth that responded to the vitality test were considered vital and included in the study.
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental (Teethmate) and Control Groups | Since the study was designed as split-mouth, all participants had both experimental and control groups . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | Postoperative hypersensitivity was evaluated using a 10-cm Visual Analogue Scale (VAS). The scale consisted of a straight 10-cm line with endpoints defining extreme limits: "no pain at all" (score = 0) and "pain as bad as it could be" (score = 10). Participants were asked to mark their perceived pain level on the line between the two endpoints. The distance (in cm) from the "no pain" end to the mark represented the participant's pain score. Higher scores indicated greater hypersensitivity (worse outcome). | Posted | Mean | Standard Deviation | cm on a 10-point Visual Analogue Scale | 7 days after restoration | restorations | restorations |
|
Up to 7 days and 6 weeks after restorative procedure
Participants were actively and systematically monitored for any adverse events, including temporary sensitivity, discomfort, or soft tissue irritation, during treatment and at follow-up visits after the restorative procedures.
Of the 50 total participants, 49 attended the 1-week and 47 attended the 6-week follow-up. No non-serious adverse events were reported or observed during the study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Because this was a split-mouth design, each participant received both interventions (Teethmate and Control) on different teeth. Therefore, adverse events could not be attributed to a single intervention. Adverse event data are reported for all participants combined. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leyla Kerimova Köse | Baskent University | +905378986689 | lkerimova@baskent.edu.tr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Oct 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2019 | Oct 4, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
|
| teeth |
|
| years |
| Participants |
|
|
| Sex/Gender, Customized | overall 50 participants enrolled | Number | participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Preoperative Vitality Measurement | Pulp vitality of each tooth was evaluated using a D624 pulp tester (Parkell Inc, Edgewood, NY, USA.). A toothpaste was applied to the probe tip, and the electrode was placed on the middle third of the buccal surface. The device intensity was gradually increased until the participant felt a mild tingling sensation. If the patient feels an uncomfortable sensation, such as tingling, warmth, or pain, the tooth pulp is considered vital. No score recording was performed. Electric pulp tester used only for checking the vitality of teeth and excluding them in case of negative (nonvital) response. | Count of Units | teeth | teeth |
|
|
| OG001 | Negative Control | Half of the cavities will be restored without application of Teethmate Desensitizer. POS after 6 weeks was reported in 40.4% of teeth of control group. |
|
|
| Primary | Numerical Rating Scale (NRS) | Progress of postoperative hypersensitivity will be also evaluated by using Numerical Rating Scale with five possibilities for the patient to state how much sensitivity there is in each tooth. The patients will have the option of saying whether the sensitivity was equal to 0 (none), 1 (mild), 2 (moderate), 3 (considerable), or 4 (severe). The mean and standard deviation (SD) of NRS scores were calculated for each group. | Posted | Mean | Standard Deviation | score on a scale | 7 days after restoration | restorations | restorations |
|
|
|
| Secondary | Presence of Postoperative Hypersensitivity (Patient-reported at 6 Weeks) | This patient-reported outcome was pre-specified in the study protocol to assess the presence of postoperative hypersensitivity at 6 weeks. | Posted | Count of Units | restorations | 6 weeks after restoration | restorations | restorations |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |