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

NCT ID: NCT04512625

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2020-02-27

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.

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Desensitizers

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

Desensitizers

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

Desensitizers

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jazan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Harisha Dewan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harisha Dewan, MDS

Role: PRINCIPAL_INVESTIGATOR

University of Jazan

Locations

Harisha Dewan

Jizan, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

UJazan

Identifier Type: -

Identifier Source: org_study_id