Efficacy of Desensitizing Agent,Propolis After an In-office Vital Tooth Bleaching.

NCT ID: NCT05569590

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2022-06-22

Brief Summary

This study was conducted to evaluate the efficacy of desensitizing agent Propolis, after an in -office vital tooth bleaching and to compare its desensitizing effect to traditionally used desensitizing agent fluoride varnish.

Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.

Kruskal-Wallis test was applied to check median pain score and sensitivity difference between and among the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups.

Detailed Description

Dental aesthetic is one of the great importance to the patients, various causes of tooth discoloration which usually encountered are dental fluorosis, aging, staining, smoking, medication use, etc. Different treatment options are available to treat discoloration depends on the individual case. Dental bleaching is one of the most conservative, noninvasive, low cost effective treatment modality to treat discoloration. In vital tooth bleaching dentists use 35 to 38 % hydrogen peroxide which have the deleterious effects on tooth structures. The main problem which is usually experienced by the patients with the vital tooth bleaching is dentine hypersensitivity. Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.

Statistical analysis was carried out by using the software SPSS IBM version 26.Median and inter quartile range (IQR) were reported to describe continuous variables (pain and sensitivity score) Normality of continuous variable (VAS pain score and sensitivity score) was checked by using the Shapiro-wilk test and Kruskal-Wallis test was applied to check median pain score and sensitivity difference between the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups. Chi-squire test was applied and cross tabulation done to see the association between all groups and visual analog scale. P-values of less than or equal to ≤ 0.05 were used to determine the significance of all test results.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

One visit three application of bleaching agent (hydrogen peroxide 35%) will be performed and desensitizing agent (fluoride varnish) will be applied for 10 minutes after bleaching.

Group Type: ACTIVE_COMPARATOR

hydrogen peroxide 35%

Intervention Type: DRUG

hydrogen peroxide 35%

fluoride varnish

Intervention Type: OTHER

fluoride varnish

Propolis

One sitting vital tooth bleaching procedure will be performed. Three application each of 15 minutes of bleaching agent (hydrogen peroxide 35%) will be applied and desensitizing agent propolis in paste form will be applied for 10 minutes.

Group Type: EXPERIMENTAL

Propolis

Intervention Type: DRUG

Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.

hydrogen peroxide 35%

Intervention Type: DRUG

hydrogen peroxide 35%

Propolis mixed with bleaching agent

One visit vital tooth bleaching procedure will be performed. three application each of 15 minutes of Propolis mixed with bleaching agent (hydrogen peroxide 35%) will be applied.

Group Type: EXPERIMENTAL

Propolis

Intervention Type: DRUG

Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.

hydrogen peroxide 35%

Intervention Type: DRUG

hydrogen peroxide 35%

Interventions

Propolis

Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.

Intervention Type: DRUG

hydrogen peroxide 35%

hydrogen peroxide 35%

Intervention Type: DRUG

fluoride varnish

fluoride varnish

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Presence of all anterior teeth with mild to moderate discoloration

• Patient's age must be 18 to 30 years
• Absence of pre-operative pain or sensitivity
• Patients having no history of smoking
• Patients with no cervical lesions and exposed roots
• Good oral hygiene using simplified oral hygiene index
• NO or minimum dental hypersensitivity to heat and cold before bleaching.

Exclusion Criteria

• Candidates with severe discoloration
• Gross pathology with in oral cavity
• The Presence of heavy stains or calculus on study sites.
• Patients using any analgesics
• Patients having the use of desensitizing agent in any form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Fatima Soomro

Efficacy of desensitizing agent Propolis,after an in-office vital tooth bleaching.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatima Soomro, MDS

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Fatima Soomro

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

FSoomro

Identifier Type: -

Identifier Source: org_study_id