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

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Desensitizers
Sponsored by
University of Jazan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Pre-cementation sensitivity, Desensitizers

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harisha Dewan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Group GL (Gluma desensitizer)

Group SF (SheildForce desensitizer)

Group TS (Telio CS desensitizer)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
Post-cementation sensitivity
Patient's response to sensitivity are evaluated over a telephonic interview.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2020
Last Updated
August 11, 2020
Sponsor
University of Jazan
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1. Study Identification

Unique Protocol Identification Number
NCT04512625
Brief Title
Desensitizers in Reducing Post Tooth Preparation Sensitivity for a Fixed Dental Prosthesis
Official Title
Efficacy of Three Commercially Available Desensitizers in Reducing Post Tooth Preparation Sensitivity for a Fixed Dental Prosthesis- A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jazan

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
Pre-cementation sensitivity, Desensitizers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study was designed as a single-center, parallel, double-blind, randomized, controlled clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The application of the stimuli and the desensitizers and collection of subjects' responses during the visits was carried out by two well-trained examiners. After providing informed consent, the first examiner allocated a number to each patient. The patients were blinded to whether they were in the control group or one of the desensitizer groups. The application of the agents was also carried out by the same examiner. The tests were carried out by the second examiner who also recorded the sensitivity during the visits. Group allotment and the application of the agents were thus carried out by the first examiner, which were concealed from the second examiner who assessed and recorded the sensitivity scores, making the study double-blinded.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group GL (Gluma desensitizer)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group SF (SheildForce desensitizer)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group TS (Telio CS desensitizer)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Desensitizers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-cementation sensitivity
Description
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).
Time Frame
First Visit, 3 hours after preparation.
Title
Pre-cementation sensitivity
Description
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).
Time Frame
Second Visit, 1 week after tooth preparation.
Title
Pre-cementation sensitivity
Description
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).
Time Frame
Third Visit, 1 week after metal try in.
Title
Post-cementation sensitivity
Description
Patient's response to sensitivity are evaluated over a telephonic interview.
Time Frame
2 weeks post cementation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harisha Dewan, MDS
Organizational Affiliation
Jazan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harisha Dewan
City
Jazan
ZIP/Postal Code
45142
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no plan to share IPD. However, the interested researchers can request it directly to us if the need arises.

Learn more about this trial

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

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