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

NCT05569590 | Completed DMC

• 1 other identifier: FSoomro
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis; Vital tooth bleaching

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

Control

ACTIVE COMPARATOR

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%; Other: fluoride varnish

Propolis

EXPERIMENTAL

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: Propolis; Drug: hydrogen peroxide 35%

Propolis mixed with bleaching agent

EXPERIMENTAL

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: Propolis; Drug: hydrogen peroxide 35%

Interventions

Propolis DRUG

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

Propolis; Propolis mixed with bleaching agent

hydrogen peroxide 35% DRUG

hydrogen peroxide 35%

Control; Propolis; Propolis mixed with bleaching agent

fluoride varnish OTHER

fluoride varnish

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Fatima Soomro

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Tooth Discoloration; Dentin Sensitivity

Interventions

Propolis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Fatima Soomro, MDS

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Efficacy of desensitizing agent Propolis,after an in-office vital tooth bleaching.

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 6, 2022
• Study Start: May 14, 2021
• Primary Completion: December 25, 2021
• Study Completion: June 22, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)