Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining

BLEACHING EFFECT OF STRAWBERRY EXTRACT VERSUS HYDROGEN PEROXIDE IN PATIENTS WITH EXRINSIC STAINING A RANDOMIZED CLINICAL TRIAL

with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity.

Study Overview

• Status: Not yet recruiting
• Conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract
• Intervention / Treatment: Other: strawberry extract.

Detailed Description

The whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. The ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. The more amount of ellagic acid will produce more potential OH clusters as a powerful oxidizer thus make the more effective bleaching process. Ellagic acid releases the OH and H radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. Ellagic acid has an OH cluster, not COOH cluster like any other acids. The electronegativity of the OH group will be easier to break and react with the organic molecules of tooth enamel.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participant inclusion criteria:

1. At least 18 years old.
2. Good general and oral health.
3. six present maxillary anterior teeth.

Tooth inclusion criteria:

1. yellowing of teeth due to age.
2. stains due to coffee or tea.

3. light tetracycline stain.

   • Exclusion Criteria:

participant exclusion criteria:

1. patients undergoing radiotherapy or chemotherapy.
2. Pregnant females or breast feeders.
3. Bruxism and patients who reported tooth sensitivity.

Tooth exclusion criteria:

1. Hypoplastic enamel.
2. carious lesion.
3. sensitive recession area or sensitive tooth.
4. Amalgam staining.
5. Non vital tooth.
6. Discolration due to pulp trauma or necrosis.
7. presence of non carious cervical lesion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with extrinsic staining will be treated with strawberry extract.	Other: strawberry extract.; strawberry has a whitening effect due to its content of ellagic and maleic acids. the presence of acidic components namely ascorbic acid may increase the surface energy by removing the surface debris, thereby allowing the citric and maleic acids to penetrate into tooth surface to remove the surface stains.
Active Comparator: patients with extrinsic staining will be treated with Hydrogen peroxide bleaching agent.	Other: strawberry extract.; strawberry has a whitening effect due to its content of ellagic and maleic acids. the presence of acidic components namely ascorbic acid may increase the surface energy by removing the surface debris, thereby allowing the citric and maleic acids to penetrate into tooth surface to remove the surface stains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleaching effect of strawberry extract versus Hydrogen peroxide.	objective assessment for the bleaching effect by spectrophotometer.	immediately , one week and one month after application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative sensitivity.	Tooth sensitivity is scored according to the VRS verbal Rating scale, where 0=none, 1=mild, 2=moderate, 3=considerable, and 4=severe	immediately after bleaching agent removal , 24 hours after application.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Strawberry extract

Drug and device information, study documents

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