Evaluation of the Effectiveness of Calcium-Phosphate-Containing Desensitizing Agent on Postoperative Sensitivity in Composite Restorations: A Double-Blind Prospective Randomized Controlled Study
Phase: NA
Conditions: Postoperative Pain
Sponsor: Baskent University

Official Title:
Evaluation of the Effect of a Hydroxyapatite-Forming Desensitizing Agent on
Postoperative Sensitivity in Composite Restorations
NCT Number:
NCT04540835
Document Date / Version:
Version 1.0  01 November 2019

PROJECT SUMMARY
Title
Evaluation of the Effect of a Hydroxyapatite-Forming Desensitizing Agent on
Postoperative Sensitivity in Composite Restorations
INTRODUCTION AND GENERAL INFORMATION
Nowadays, both esthetic concerns and ecological awareness have led to the
preference of composite resin instead of amalgam in most restorations. However,
the acidic adhesive monomers used during the application of composite resins can
cause pain following restoration. This type of pain, defined as postoperative
sensitivity, generally occurs independently of restoration failure and is reported by
patients at different levels and intensities. Typically, this pain lasts for a period of
several days to one month after the restoration and then subsides. In rare cases
where severe pain occurs, endodontic treatment may become necessary (1).
Postoperative sensitivity may arise due to several factors, including the remaining
dentin thickness, the diameter and patency of dentin tubules after acid etching, the
general condition of the pulp, and clinician-related factors (2). To reduce
postoperative sensitivity, several approaches have been suggested, such as
avoiding excessive drying during cavity preparation (3), applying desensitizers and
liners to the cavity (2), and using self-etch adhesives (4). However, current evidence
shows that the type of adhesive itself is not a determining factor for postoperative
sensitivity (5). It has also been reported that desensitizers applied to the cavity may
influence bond strength. Therefore, careful selection of the material to be applied is
important for the success of the restoration.
Teethmate Desensitizer (Kuraray Noritake), a desensitizing agent containing
tetracalcium phosphate and dicalcium phosphate anhydrous, forms hydroxyapatite
through a dissolutionprecipitation reaction. An in vitro study demonstrated that this
material does not adversely affect bond strength (6). Another in vitro study (7)
reported that while Teethmate Desensitizer reduced adhesive bond strength, it also
decreased microleakage. For this reason, it was suggested that in multimode
adhesives used in self-etch mode, Teethmate Desensitizer could be applied to the
cavity before adhesive application in order to reduce postoperative sensitivity.
Although the effectiveness of Teethmate Desensitizer in occluding dentin tubules
and reducing sensitivity has been reported in clinical studies (810), no study
investigating its effect on postoperative sensitivity following composite resin
restorations has been identified.
Based on literature review, the aim of this phase IV study is to evaluate the effects of
Teethmate Desensitizer, when applied under composite restorations, on
postoperative sensitivity compared with a control group.

MATERIALS AND METHODS
This study will be conducted in three phases. In the first phase, sample size
calculation was performed using statistical methods.
Statistical Pre-analysis:
The sample size was calculated using the online calculator at
www.sealedenvelope.com. Assuming a power of 90% and an error margin of 5%, the
required number for each group (experimental and control teeth) was found to be
43. Since a split-mouth design will be used, in which each patient will have both
experimental and control groups, the required number of participants was also
determined to be at least 43. Considering possible dropouts during the study, the
final sample size was set at 50 participants. Randomization will be achieved using a
blocked randomization technique at www.sealedenvelope.com. For blocked
randomization, the seed number will be set as 12345 and block size as 2.
In the second phase, volunteer participants will be selected among patients who
apply to the Faculty of Dentistry, Bakent University, and are referred to the
Department of Restorative Dentistry for treatment after clinical and radiological
examination revealed carious lesions. The inclusion criteria will be as follows:
- Voluntary acceptance of participation in the study
- Age between 1865 years
- Presence of at least 12 teeth in occlusion
- The teeth to be included must have natural antagonists and adjacent teeth (normal
occlusion)
- Anterior or posterior teeth with primary or secondary carious lesions in which the
cavity preparation is expected to approach the pulp closely but without pulpal
exposure
- Each participant must have two teeth, one on the right and one on the left, fulfilling
the above criteria
- Absence of any other factor causing sensitivity or pain that might interfere with
evaluation
Exclusion criteria:
- Refusal to participate in the study
- Age under 18 or over 65 years
- Presence of dental or orofacial pain
- Presence of bruxism
- Presence of advanced periodontal disease
- Presence of systemic diseases that may hinder treatment procedures or follow-up
visits
- Teeth with excessive loss of tooth structure requiring full crown restoration, or with
severe attrition, cracks, or non-vital teeth
- Pulpal exposure during cavity preparation
- Presence of gingival recession
- Use of analgesics, anti-inflammatory, or psychotropic drugs within the last 15 days
or currently using them
- Pregnancy or lactation
- Known allergy to the materials to be used
Eligible individuals will be invited to participate in the study after verbal explanation

of the purpose and methodology. Participation will be voluntary, and those who
accept will sign an Informed Consent Form. If deemed necessary, participants will
receive oral hygiene motivation, and interventions will begin once oral hygiene has
reached a satisfactory level.
In the third phase, before starting treatment of the teeth diagnosed with caries
through clinical and radiological examination, vitality tests will be performed. After
cavity preparation of two teeth per participant, the cavities will be isolated. At the
point closest to the pulp, a calcium hydroxide-based pulp capping agent (Dycal,
Dentsply Sirona, York, USA) will be applied in paste form. Subsequently, Teethmate
Desensitizer will be applied according to the manufacturers instructions to one
cavity randomly, while the other will receive no desensitizer. To ensure
randomization, pre-prepared allocation lists from www.sealedenvelope.com will be
placed in opaque envelopes, which will be opened only at the time of intervention.
When necessary depending on cavity type, a matrix system (Mylar strip, sectional
matrix, or Tofflemire) will be applied before restoration. All cavities will be treated
with a one-step self-etch adhesive (Clearfil SE Bond, Kuraray Noritake, Tokyo, Japan)
according to manufacturers instructions and light-cured with an LED unit (LedMax
Cordless 550, Benliolu Dental, Ankara, Turkey) at a constant intensity >1,500
mW/cm for 10 seconds. Restorations will be completed using a universal composite
resin (Filtek Z250, 3M Espe, St. Paul, MN, USA) with the oblique incremental
technique. Each increment of composite will be polymerized for 20 seconds with the
same LED device. Finishing and polishing will be performed using diamond finishing
burs, polishing rubbers, and disks (Soflex, 3M Espe, St. Paul, MN, USA). All
restorations will be performed by a single operator.
After restoration, participants will be given two forms (one for each tooth) to record
their daily pain levels for one week. Instructions for filling out the forms will be
provided. The forms will include the Numerical Rating Scale (NRS, 04) and the
Visual Analog Scale (VAS, 0100 mm). One week later, patients will return for
follow-up, and the completed forms will be collected. Six weeks after the
restorations, patients will return for another follow-up. At both the one-week and
six-week follow-up visits, restorations will be evaluated by another dentist to ensure
double blinding.
At the one-month control visit, tooth vitality will first be assessed. If the tooth is vital,
postoperative sensitivity will be evaluated using VAS scores and by applying a cold
spray (Ice Spray, Picdare S.p.A, Casnate con Bernate, Italy) with a cotton pellet to
the mid-buccal surface of the teeth for 5 seconds.
Study Start Date: May 3, 2021
Study Completion Date: May 3, 2022

STATISTICAL ANALYSIS
Measurements will be obtained from two paired teeth of the same patient. The VAS
and NRS values of these paired groups will be compared. For this purpose,
chi-square test will be used for NRS values, and independent two-sample t-test will
be used for VAS values. The significance level will be set at p = 0.05.
EXPECTED OUTCOMES AND SCIENTIFIC CONTRIBUTIONS
The aim of this study is to evaluate the effect of applying a hydroxyapatite-forming
desensitizing material (Teethmate Desensitizer) to the cavity prior to restoration,
compared with a control. Teethmate Desensitizer is a biocompatible material.
Therefore, it may be effective in reducing postoperative sensitivity in cavities and
increasing patient comfort.
As a result of this original study, it is expected that data on the effect of using
Teethmate Desensitizer beneath restorative materials on postoperative sensitivity
will contribute both to national and international literature.

REFERENCES
1. Survashe M. Immediate Post-operative Sensitivity after Composite Resin
RestorationA Review of Treatment Protocol. Int J Dent and Oral Heal.
2016;2(2):59-68.
2. Sabbagh J, Fahd JC, McConnell RJ. Post-operative sensitivity and posterior
composite resin restorations: a review. Dental Update. 2018;45(3):207-13.
3. Porto I. Post-operative sensitivity in direct resin composite restorations: clinical
practice guidelines. IJRD. 2012;1:1-12.
4. Costa T, Rezende M, Sakamoto A, Bittencourt B, Dalzochio P, Loguercio A, et al.
Influence of adhesive type and placement technique on postoperative sensitivity in
posterior composite restorations. Operative dentistry. 2017;42(2):143-54.
5. Reis A, Loguercio AD, Schroeder M, Luque-Martinez I, Masterson D, Maia LC. Does
the adhesive strategy influence the post-operative sensitivity in adult patients with
posterior resin composite restorations?: A systematic review and meta-analysis.
Dental Materials. 2015;31(9):1052-67.
6. Gupta T, Nagaraja S, Mathew S, Narayana IH, Madhu K, Dinesh K. Effect of
desensitization using bioactive glass, hydroxyapatite, and diode laser on the shear
bond strength of resin composites measured at different time intervals: An In vitro
Study. Contemporary clinical dentistry. 2017;8(2):244-47.
7. Siso S, Dnmez N, Kahya D, Uslu Y. The effect of calcium phosphate-containing
desensitizing agent on the microtensile bond strength of multimode adhesive agent.
Nigerian journal of clinical practice. 2017;20(8):964-70.
8. Mehta D, Jyothi S, Moogi P, Finger WJ, Sasaki K. Novel treatment of inoffice tooth
bleaching sensitivity: A randomized, placebocontrolled clinical study. Journal of
Esthetic and Restorative Dentistry. 2018;30(3):254-58.
9. Mehta D, Gowda Vs, Santosh A, Finger WJ, Sasaki K. Randomized controlled
clinical trial on the efficacy of dentin desensitizing agents. Acta Odontologica
Scandinavica. 2014;72(8):936-41.
10. Shetty R, Bhat AN, Mehta D, Finger WJ. Effect of a Calcium Phosphate
Desensitizer on Pre-and Postcementation Sensitivity of Teeth Prepared for
Full-Coverage Restorations: A Randomized, Placebo-Controlled Clinical Study.
International Journal of Prosthodontics. 2017;30(1): 38-42.