Evaluation of the Effectiveness of Calcium Phosphate Containing Desensitizer on Postoperative Sensitivity

NCT04540835 | Completed Results FDA Device

• 1 other identifier: DKA20/15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Presence of Postoperative Hypersensitivity (Patient-reported at 6 Weeks)

  6 weeks after restoration

Study Arms (2)

Teethmate

EXPERIMENTAL

Half of the cavities will be applied Teethmate Desensitizer following manufacturer instructions before restoration

Device: Teethmate Desensitizer (Kuraray)

Negative Control

NO INTERVENTION

Half of the cavities will be restored without application of Teethmate Desensitizer

Interventions

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)

Teethmate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Leyla Kerimova Köse
• Organization: Baskent University

lkerimova@baskent.edu.tr

+905378986689

Study Officials

• Leyla Kerimova, DDS

  Baskent University School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)