Desensitizers in Reducing Post Tooth Preparation Sensitivity for a Fixed Dental Prosthesis

Efficacy of Three Commercially Available Desensitizers in Reducing Post Tooth Preparation Sensitivity for a Fixed Dental Prosthesis- A Randomized Controlled Clinical Trial.

The main purpose of the present study was to evaluate and compare the effectiveness of three kinds of commercially available desensitizing agents: Gluma, Sheildforce plus, and Telio CS desensitizers in reducing the pre- and post-cementation sensitivity for full coverage restorations.

Study Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Biological: Desensitizers

Detailed Description

During the first visit, standard prosthodontic principles were followed to prepare the teeth for complete coverage restorations using high-speed handpiece and copious water-coolant spray. After the effect of local anesthesia was worn off, baseline sensitivity (first reading) was recorded on the VAS using Cold Test and Electric Pulp Test (EPT) . Final impression using addition silicon (Virtual from Ivoclar Vivadent, Amherst, NY) was made, and the provisional prosthesis was fabricated using Protemp TM II (3M ESPE, Germany), by the direct method using polyvinyl siloxane putty (ExpressTM STD, 3M ESPE) matrix. The first application of desensitizer was done then on the desensitizer group according to the manufacturer's recommendation. The fabricated provisional prosthesis was cemented with non-eugenol provisional cement Tempbond NE (Rely XTM TempNE, 3M ESPE, Germany) and the patient was recalled for the metal try-in. During the second visit, the provisional prosthesis was removed and the patient's response to Cold Test and EPT was again recorded on VAS (second reading) and the metal try-in was carried out. The second application of desensitizing agent was done, the provisional prosthesis was re-cemented, and the patient was recalled for final cementation. During the third visit, the provisional prosthesis was removed, the patient's response to Cold Test and EPT was again recorded (third reading), and the third application of desensitizing agent was done before cementing the final prosthesis with G-cem resin cement. The control group had similar clinical steps except for the application of desensitizer, Evaluation of sensitivity level Subjective evaluation of pain produced by cold and electrical stimulus was done, for checking pre-cementation sensitivity. Before starting the procedure, patients were explained about the Cold Test, EPT, and the VAS scores.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan, Saudi Arabia, 45142
    • Harisha Dewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The inclusion criteria were: minimum of one posterior tooth missing and patient in need of fixed dental prosthesis (porcelain fused to metal); abutment teeth with a vital pulp, normal apical periodontal ligament space, no history of hypersensitivity; and previous restorations not involving more than 50% of the coronal tooth surface.

Exclusion Criteria:

• The exclusion criteria were: patients with chronic diseases, gross oral pathology, or those undergoing any kind of medications; subjects with teeth that had extensive restorations, mobility or periodontal diseases; pregnant or lactating women; and individuals participating in any other clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Sensitivity level scores were evaluated on the Visual Analogue Scale using cold stimuli (Cold Test) and electrical stimuli (Electric Pulp Test) at all the 3-time intervals, i. e first, second, and the third visit and then telephonically two weeks after the final cementation.
Experimental: Group GL (Gluma desensitizer); In desensitizer groups, respective desensitizer application was done following the manufacturer's directions immediately after tooth preparation before final impressions were made (first visit), before metal try-in (second visit) and before final cementation (third visit). Sensitivity level scores were evaluated, before the desensitizer application, on the Visual Analogue Scale using cold stimuli (Cold Test) and electrical stimuli (Electric Pulp Test) at all the 3-time intervals, i. e first, second, and the third visit and then telephonically two weeks after the final cementation. The data were statistically analyzed using one-way ANOVA followed by post-hoc Bonferroni and unpaired t-test.	Biological: Desensitizers; The main aims and objectives of the present study were to evaluate and compare the effectiveness of three commercially available desensitizing agents: Gluma (Hareus Kulzer), Sheildforce Plus (Tokuyama), and Telio CS (Ivoclar Vivadent) desensitizer in reducing the pre- and post-cementation sensitivity for full coverage restorations.
Experimental: Group SF (SheildForce desensitizer); In desensitizer groups, respective desensitizer application was done following the manufacturer's directions immediately after tooth preparation before final impressions were made (first visit), before metal try-in (second visit) and before final cementation (third visit). Sensitivity level scores were evaluated, before the desensitizer application, on the Visual Analogue Scale using cold stimuli (Cold Test) and electrical stimuli (Electric Pulp Test) at all the 3-time intervals, i. e first, second, and the third visit and then telephonically two weeks after the final cementation. The data were statistically analyzed using one-way ANOVA followed by post-hoc Bonferroni and unpaired t-test.	Biological: Desensitizers; The main aims and objectives of the present study were to evaluate and compare the effectiveness of three commercially available desensitizing agents: Gluma (Hareus Kulzer), Sheildforce Plus (Tokuyama), and Telio CS (Ivoclar Vivadent) desensitizer in reducing the pre- and post-cementation sensitivity for full coverage restorations.
Experimental: Group TS (Telio CS desensitizer); In desensitizer groups, respective desensitizer application was done following the manufacturer's directions immediately after tooth preparation before final impressions were made (first visit), before metal try-in (second visit) and before final cementation (third visit). Sensitivity level scores were evaluated, before the desensitizer application, on the Visual Analogue Scale using cold stimuli (Cold Test) and electrical stimuli (Electric Pulp Test) at all the 3-time intervals, i. e first, second, and the third visit and then telephonically two weeks after the final cementation. The data were statistically analyzed using one-way ANOVA followed by post-hoc Bonferroni and unpaired t-test.	Biological: Desensitizers; The main aims and objectives of the present study were to evaluate and compare the effectiveness of three commercially available desensitizing agents: Gluma (Hareus Kulzer), Sheildforce Plus (Tokuyama), and Telio CS (Ivoclar Vivadent) desensitizer in reducing the pre- and post-cementation sensitivity for full coverage restorations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-cementation sensitivity	Pre-cementation sensitivity is evaluated after Cold Test and EPT using the Visual Analog Scale(1-10, 0 = 'no pain' (non-sensitive) and 10 ='severe pain' (extremely hypersensitive).	First Visit, 3 hours after preparation.
Pre-cementation sensitivity	Pre-cementation sensitivity level is evaluated after Cold Test and EPT using the Visual Analog Scale(1-10, 0 = 'no pain' (non-sensitive) and 10 ='severe pain' (extremely hypersensitive).	Second Visit, 1 week after tooth preparation.
Pre-cementation sensitivity	Pre-cementation sensitivity is evaluated after Cold Test and EPT using the Visual Analog Scale(1-10, 0 = 'no pain' (non-sensitive) and 10 ='severe pain' (extremely hypersensitive).	Third Visit, 1 week after metal try in.
Post-cementation sensitivity	Patient's response to sensitivity are evaluated over a telephonic interview.	2 weeks post cementation.

Collaborators and Investigators

• Sponsor: University of Jazan
• Investigators: Principal Investigator: Harisha Dewan, MDS, Jazan University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pre-cementation sensitivity, Desensitizers
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: UJazan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently, there is no plan to share IPD. However, the interested researchers can request it directly to us if the need arises.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes