Postoperative PainNCT04540835
Evaluation of the Effectiveness of Calcium Phosphate Containing Desensitizer on Postoperative Sensitivity
A study testing Teethmate Desensitizer (Kuraray) in people with Postoperative Pain, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Teethmate Desensitizer (Kuraray)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Accepting to participate
- Being in the age range of 18-65
- Presence of at least 12 teeth in occlusion
- The teeth to be included in the study have natural opposite and aproximal teeth
- The teeth to be included in the study will be vital
- The anterior or posterior teeth to be included in the study, regardless of the deep carious cavity type, have a primary carious lesion that is estimated to be very close to the pulp during cavity preparation but the pulp will not expose (dentin thickness close to the remaining pulp is less than 2 mm)
- In the patient's mouth, one on the right and the other on the left 4., 5. and 6. 2 teeth matching the criteria.
Who cannot join
- Not accepting voluntarily to participate in the study 2- Being younger than 18 years old or over 65 years old 3- Presence of spontaneous toothache or orofacial pain 4- Bruxism 5- Presence of advanced periodontal disease 6- The presence of a serious systemic disease. 7- Worn, cracked or devital teeth with enough material loss to be crowned 8- Presence of lesions in the apical region after radiographic examination 9- Exposure of pulp during cavity preparation 10- Presence of gingival recession 11- Individuals who have taken painkillers, anti-inflammatory and psychotropics in the last two weeks and are currently taking 12- Pregnancy and breastfeeding individuals 13- Individuals who are allergic to the materials to be used
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Teethmate Desensitizer (Kuraray)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Teethmate | Experimental | Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration Receives: Device: Teethmate Desensitizer (Kuraray) |
| Negative Control | No intervention | Half of the cavities will be restored without application of Teethmate Desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 7 days after restoration
Secondary outcomes (1)
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.
Measured: 6 weeks after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Oct 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kerimova, Baskent University
- Investigators
- Leyla Kerimova, DDS, Principal investigator, Baskent University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540835
- Sponsor's protocol ID
- DKA20/15
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2020
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04540835
- Acronym / sponsor ID
- DKA20/15
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teethmate | Experimental | Device: Teethmate Desensitizer (Kuraray)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Accepting to participate
- Being in the age range of 18-65
- Presence of at least 12 teeth in occlusion
- The teeth to be included in the study have natural opposite and aproximal teeth
- The teeth to be included in the study will be vital
Key exclusion criteria (1 listed)
- Not accepting voluntarily to participate in the study 2- Being younger than 18 years old or over 65 years old 3- Presence of spontaneous toothache or orofacial pain 4- Bruxism 5- Presence of advanced periodontal disease 6- The presence of a serious systemic disease. 7- Worn, cracked or devital teeth with enough material loss to be crowned 8- Presence of lesions in the apical region after radiographic examination 9- Exposure of pulp during cavity preparation 10- Presence of gingival recession 11- Individuals who have taken painkillers, anti-inflammatory and psychotropics in the last two weeks and are currently taking 12- Pregnancy and breastfeeding individuals 13- Individuals who are allergic to the materials to be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teethmate Desensitizer (Kuraray)Calcium phosphate desensitizer applied after caries removal. After restored using an oblique incremental technique with a composite resin (Filtek Z250, 3M Espe, USA) | Device | Teethmate |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 7 days after restoration
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).
Numerical Rating Scale (NRS)
Time frame: 7 days after restoration
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.
1 secondary outcome
Presence of Postoperative Hypersensitivity (Patient-reported at 6 Weeks)
Time frame: 6 weeks after restoration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Kerimova, DDS principal investigator
Baskent University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teethmate Desensitizer (Kuraray) in people with Postoperative Pain, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 7 days after restoration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.