Enamel Abrasion and Stain Removal Efficacy

November 9, 2022 updated by: Mohamed Osama Metwally, Cairo University

Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes

Enamel abrasion and stain removal efficacy of two whitening toothpastes

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Statement of the problem:

Access to in-office treatments is restricted to a lot of population. Therefore, there has been an interest in developing methods so that patients can remove stains and apply tooth whitening at home. Accordingly, toothpastes, due to their ease of use and low cost, have been used as vehicles for whitening agents as an alternative to home/office whitening.

Hydrogen peroxide is the most commonly used agent for whitening teeth, which is used in various concentrations according to various techniques at home and office. Bleaching of teeth in office is done at a high concentration of Hydrogen peroxide for a specified period of time. In addition to conventional whitening treatments, over-the-counter products, including gels, toothpastes, bleaching strips, mouthwashes, and pens with different Hydrogen peroxide levels, have been developed. In-office teeth whitening is one of the more costly forms of teeth whitening and the concentration of the bleaching element is higher, it is better monitored by a professional.

Whitening toothpaste is probably the one of the most affordable options for someone looking to whiten their teeth at home, which contain abrasive and chemical agents and have the ability to remove external stains from the tooth. The abrasiveness of toothpastes depends on the hardness, size, and shape of abrasive particles. Furthermore, factors such as the brushing technique, brushing pressure, toothbrush hardness, and the number of brush strokes affect tooth abrasion. Abrasive agents include silica, phosphates, carbonates, and bicarbonates Chemical agents present in whitening toothpastes are sodium citrate, phosphate salt, which react with chromogenic molecules of superficial dental stains and eliminate them from the tooth surface.

Whitening toothpastes include different active ingredients in their composition. It normally contain a higher amount of abrasives and detergents than do conventional toothpastes In this sense, it is important to point out that toothpastes with higher amounts of abrasives may produce increased surface roughness in dental tissues, or restorations, or even tooth sensitivity, especially if they are used routinely

Rationale:

Today, active charcoal is added to toothpastes which are marketed as charcoal toothpastes. The first report on the use of charcoal in oral and dental hygiene has been attributed to Hippocrates in ancient Greece. Charcoal is used as powder, soot, coal, and ash in different countries. Charcoal-based products are used in medical treatments, such as its use as an antidote for acute poisoning, drug overdose, skin infections, Charcoal is used legally for the coloring of food in China, Japan, and Korea to improve health.

Activated charcoal is produced as a natural method of the partial oxidation of various materials. High-porosity activated charcoal has the ability to exchange ion in the mouth through nanopores and can attach to tooth enamel and remove tooth-coloring agents (because of its capacity of adsorbing pigments, chromophores, and stains from the tooth surface). The application of this product has been suggested to eliminate some dental coloring agents. Charcoal can help tooth whitening through tooth abrasion.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

In vivo:

  • Patients inclusion:

    1. Adult male and female patients ≥18 years.
    2. Good oral and general health and oral hygiene have at least eight natural anterior teeth (incisors and canines) assessable for extrinsic stain and be available for all study appointments.

Tooth inclusion:

Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.

In vitro:

Teeth inclusion criteria:

  1. Intact, free of caries or restorations.
  2. No cervical lesions .

Exclusion Criteria:

In vivo:

Patients exclusion:

  1. Uncooperative behavior.
  2. Patients allergic to tooth paste material.
  3. Patient with history of medical disease, drug therapies or any other serious relevant problem.
  4. Pregnant or breastfeeding women.
  5. Patients with fixed orthodontic appliances
  6. Patients who had professional tooth whitening, within the last six months.
  7. Patients who had significant amounts of calculus on facial surfaces of the incisors/canines.
  8. Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition.
  9. Patients who had advanced periodontal disease on anterior teeth.
  10. Xerostomic patients.
  11. Patients who used medications which could affect saliva flow or cause staining.
  12. Patients who had undergone dental prophylaxis within 8 weeks of screening.
  13. Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline

Tooth exclusion:

  1. Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment).
  2. Restorations in anterior teeth, parafunctional habits or tooth sensitivity.
  3. Non- vital teeth

In vitro:

Teeth exclusion criteria:

  1. Intrinsically Discolored teeth caused by tetracycline, fluorosis, hyperplasia, endodontic treatment .
  2. Restorations in teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Charcoal -based whitening toothpaste.
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
Other: Charcoal -based whitening toothpaste
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
ACTIVE_COMPARATOR: Calcium carbonate /perlite containing whitening toothpaste.
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
Other: Calcium carbonate /perlite containing whitening toothpaste.
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using (calcium carbonate /perlite) containing toothpaste. Soft bristles toothbrushes will provided to all patients. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stain score
Time Frame: T0: Baseline
mcpherson modification of the stain index and area x intensity
T0: Baseline
Stain score
Time Frame: T1: 4 weeks
mcpherson modification of the stain index and area x intensity
T1: 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface roughness
Time Frame: T0: Baseline
Atomic Force Microscopy
T0: Baseline
Surface roughness
Time Frame: T1: 3 minutes equivalent to 2 times a day for one month.
Atomic Force Microscopy
T1: 3 minutes equivalent to 2 times a day for one month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (ACTUAL)

November 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Charcoal based whitening

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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