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

NCT04512625 | Completed DMC

• 1 other identifier: UJazan
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Keywords

Pre-cementation sensitivity, Desensitizers

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (4)

Control group

NO INTERVENTION

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 GL (Gluma desensitizer)

EXPERIMENTAL

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

Group SF (SheildForce desensitizer)

EXPERIMENTAL

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

Group TS (Telio CS desensitizer)

EXPERIMENTAL

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

Interventions

Desensitizers 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 GL (Gluma desensitizer); Group SF (SheildForce desensitizer); Group TS (Telio CS desensitizer)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Harisha Dewan

Jizan, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Harisha Dewan, MDS

  University of Jazan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The present study was designed as a single-center, parallel, double-blind, randomized, controlled clinical trial

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 13, 2020
• Study Start: November 28, 2019
• Primary Completion: January 30, 2020
• Study Completion: February 27, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)