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

Effiacacy of Desensitizing Agent,After an In-office Vital Tooth Bleaching. A Randomized Double Blind Clinical Trial Trial.

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: hydrogen peroxide 35%; Other: fluoride varnish; Drug: Propolis

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Fatima Soomro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:• Patients with any kind of restoration, calculus or heavy stain on study site

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: hydrogen peroxide 35%; hydrogen peroxide 35%; Other: fluoride varnish; fluoride varnish
Experimental: 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.	Drug: hydrogen peroxide 35%; hydrogen peroxide 35%; Drug: Propolis; Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.
Experimental: 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.	Drug: hydrogen peroxide 35%; hydrogen peroxide 35%; Drug: Propolis; Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of efficacy of desensitizing agent Propolis after an in office vital tooth bleaching	Visual analogue scale (VAS) was used to assess the postoperative dentine hypersensitivity after procedure. Performa was provided to the patients which include VAS. the scale is usually a straight line 10 cm line which clearly defined boundries 0= no pain,1-3=mild pain,4-6 moderate pain and 7-10 severe pain.patients marked the no according to their pain ( sensitivity) level.	Post operative sensitivity was assessed for 7 days after treatment. Visual analogue scale was used to assess the pain (sensitivity).

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Fatima Soomro, MDS, DUHS

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis; Vital tooth bleaching
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Fluorides; Hydrogen Peroxide; Fluorides, Topical; Propolis
• Other Study ID Numbers: FSoomro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No