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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Propolis
hydrogen peroxide 35%
fluoride varnish
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis, Vital tooth bleaching

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fatima Soomro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Propolis

Propolis mixed with bleaching agent

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
October 5, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05569590
Brief Title
Efficacy of Desensitizing Agent,Propolis After an In-office Vital Tooth Bleaching.
Official Title
Effiacacy of Desensitizing Agent,After an In-office Vital Tooth Bleaching. A Randomized Double Blind Clinical Trial Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis, Vital tooth bleaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects are randomly placed into one of the groups: Control, Propolis and Propolis mixed with bleaching agent. In Propolis group Propolis paste will be applied for 10 minutes. Post operative sensitivity will be assessed for 7 days by using visual analogue and Shiff's scale.
Masking
ParticipantOutcomes Assessor
Masking Description
Double (participant, Outcome assessor) It is double blinded study in which participant will be blinded. the assessor who will assess the post operative sensitivity of the participant will also be blinded regarding the intervention.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Propolis
Arm Type
Experimental
Arm Description
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.
Arm Title
Propolis mixed with bleaching agent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propolis
Intervention Description
Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.
Intervention Type
Drug
Intervention Name(s)
hydrogen peroxide 35%
Intervention Description
hydrogen peroxide 35%
Intervention Type
Other
Intervention Name(s)
fluoride varnish
Intervention Description
fluoride varnish
Primary Outcome Measure Information:
Title
Assessment of efficacy of desensitizing agent Propolis after an in office vital tooth bleaching
Description
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.
Time Frame
Post operative sensitivity was assessed for 7 days after treatment. Visual analogue scale was used to assess the pain (sensitivity).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:• 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Soomro, MDS
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima Soomro
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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