Trial Outcomes & Findings for Evaluation of the Effectiveness of Calcium Phosphate Containing Desensitizer on Postoperative Sensitivity (NCT NCT04540835)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

7 days after restoration

Results posted on

2025-12-23

Participant Flow

Unit of analysis: restorations

Participant milestones

Participant milestones
Measure	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
Week 1 STARTED	50 100
Week 1 Teethmate Desensitizer	49 49
Week 1 Negative Control	49 49
Week 1 COMPLETED	49 98
Week 1 NOT COMPLETED	1 2
Week 6 STARTED	49 98
Week 6 Teethmate Desensitizer	47 47
Week 6 Negative Control	47 47
Week 6 COMPLETED	47 94
Week 6 NOT COMPLETED	2 4

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Week 1 Lost to Follow-up	1
Week 6 Pregnancy	1
Week 6 Lack of Efficacy	1

Baseline Characteristics

overall 50 participants enrolled

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental (Teethmate) and Control Groups n=100 teeth Since the study was designed as split-mouth, all participants had both experimental and control groups .
Sex/Gender, Customized All genders	50 participants n=50 Participants • overall 50 participants enrolled
Age, Continuous	30 years STANDARD_DEVIATION 12 • n=50 Participants
Preoperative Vitality Measurement	100 teeth n=100 teeth

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Teethmate n=49 restorations Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration 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) POS after 6 weeks was reported in 34% of teeth of experimental group.	Negative Control n=49 restorations 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.
Visual Analog Scale (VAS)	0.4 cm on a 10-point Visual Analogue Scale Standard Deviation 1.6	1.3 cm on a 10-point Visual Analogue Scale Standard Deviation 5.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Teethmate n=49 restorations Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration 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) POS after 6 weeks was reported in 34% of teeth of experimental group.	Negative Control n=49 restorations 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.
Numerical Rating Scale (NRS)	0.1 score on a scale Standard Deviation 0.3	0.1 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 6 weeks after restoration

This patient-reported outcome was pre-specified in the study protocol to assess the presence of postoperative hypersensitivity at 6 weeks.

Outcome measures

Outcome measures
Measure	Teethmate n=47 restorations Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration 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) POS after 6 weeks was reported in 34% of teeth of experimental group.	Negative Control n=47 restorations 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.
Presence of Postoperative Hypersensitivity (Patient-reported at 6 Weeks)	47 restorations	47 restorations

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leyla Kerimova Köse

Baskent University

Phone: +905378986689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place