Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations

NCT05024669 | Completed DMC

• 1 other identifier: Harisha
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.

Conditions

Sensitivity

Keywords

Gluma; Sheildforce Plus; Telio CS; Desensitisers

Outcome Measures

Primary Outcomes (3)

• Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

  The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar.

  Within 24 hours

• Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

  The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar.

  After one week

• Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.

  The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar.

  after one month

Study Arms (4)

Control Group

NO INTERVENTION

where no desensitizer application was done,

Group GL

EXPERIMENTAL

applied with Gluma dentin desensitizer

Combination Product: Gluma desensitiser

Group SF

EXPERIMENTAL

applied with Shieldforce desensitizer

Combination Product: Sheildforce Plus desensitiser

Group TC

EXPERIMENTAL

applied with Telio CS desensitizer

Combination Product: Telio CS desensitiser

Interventions

Gluma desensitiser COMBINATION_PRODUCT

Gluma desensitiser was used before restoration.

Group GL

Sheildforce Plus desensitiser COMBINATION_PRODUCT

Sheildforce Plus desensitiser was used before restoration.

Group SF

Telio CS desensitiser COMBINATION_PRODUCT

Telio CS desensitiser was used before restoration.

Group TC

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The selection criteria:
• Age was 20-45 years.
• Vital teeth, (electric pulp test)
• Apical periodontal ligament space radiographically identified
• The remaining dentin thickness at least 1mm.

You may not qualify if:

• Restored, periodontally weak nonvital teeth are excluded.

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Harisha Dewan

Jizan, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Harisha Dewan

  University of Jazan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 27, 2021
• Study Start: December 10, 2020
• Primary Completion: April 10, 2021
• Study Completion: May 10, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)