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

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512625
• Other study ID #: UJazan
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: August 2020
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 27, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Harisha Dewan	Jazan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Post-cementation sensitivity	Patient's response to sensitivity are evaluated over a telephonic interview.	2 weeks post cementation.