search
Back to results

Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes: An In-vitro and In-vivo Trial

Primary Purpose

Tooth Abrasion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt
Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Abrasion focused on measuring Charcoal based toothpaste, External tooth stains, Teeth abrasion

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

IN VIVO: Patients inclusion: Adult male and female patients ≥18 years. 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. Patients exclusion: Uncooperative behavior. Patients allergic to tooth paste material. Patient with history of medical disease, drug therapies or any other serious relevant problem. Pregnant or breastfeeding women. Patients with fixed orthodontic appliances Patients who had professional tooth whitening, within the last six months. Patients who had significant amounts of calculus on facial surfaces of the incisors/canines. Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition. Patients who had advanced periodontal disease on anterior teeth. Xerostomic patients. Patients who used medications which could affect saliva flow or cause staining. Patients who had undergone dental prophylaxis within 8 weeks of screening. Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline. Tooth inclusion: ▪ Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease. Tooth exclusion: Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment). Restorations in anterior teeth, parafunctional habits or tooth sensitivity. Non- vital teeth. IN-VITRO: Teeth inclusion criteria: Intact, free of caries or restorations. No cervical lesions Teeth exclusion criteria: Intrinsically Discolored teeth caused by tetracycline, fluorosis, hyperplasia, endodontic treatment . Restorations in teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Charcoal -based whitening toothpaste

    Calcium carbonate /perlite containing whitening toothpaste

    Arm Description

    signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt

    signal whitening moonlight toothpaste Unilever Mashreq - Egypt

    Outcomes

    Primary Outcome Measures

    Stain scores as per Macpherson modification of the Lobene stain index
    Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration faint stain clearly visible stain, orange to brown (moderate stain) dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: thin line, can be continuous (< 1/3) thick line or band (>1/3, <2/3) covering total area (> 2/3)
    Stain scores as per Macpherson modification of the Lobene stain index
    Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration faint stain clearly visible stain, orange to brown (moderate stain) dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: thin line, can be continuous (< 1/3) thick line or band (>1/3, <2/3) covering total area (> 2/3)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 24, 2022
    Last Updated
    December 24, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05650840
    Brief Title
    Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes: An In-vitro and In-vivo Trial
    Official Title
    Enamel Abrasion and Stain Removal Efficacy of Charcoal -Based and Calcium Carbonate /Perlite Whitening Toothpastes: A Randomized Clinical Trial and In-vitro Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Abrasion
    Keywords
    Charcoal based toothpaste, External tooth stains, Teeth abrasion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Charcoal -based whitening toothpaste
    Arm Type
    Experimental
    Arm Description
    signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt
    Arm Title
    Calcium carbonate /perlite containing whitening toothpaste
    Arm Type
    Active Comparator
    Arm Description
    signal whitening moonlight toothpaste Unilever Mashreq - Egypt
    Intervention Type
    Procedure
    Intervention Name(s)
    Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt
    Intervention Description
    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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. Intervention drug : whitening toothpaste charcoal based whitening toothpaste compared to calcium carbonate and perlite whitening toothpaste FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush (Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination
    Intervention Type
    Procedure
    Intervention Name(s)
    Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt).
    Intervention Description
    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 (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. The main operator will perform the tooth brushing procedures for all the patients himself twice daily. FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush(Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination Device used is atomic force microscopy to determine enamel abrasion after brushing
    Primary Outcome Measure Information:
    Title
    Stain scores as per Macpherson modification of the Lobene stain index
    Description
    Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration faint stain clearly visible stain, orange to brown (moderate stain) dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: thin line, can be continuous (< 1/3) thick line or band (>1/3, <2/3) covering total area (> 2/3)
    Time Frame
    Baseline
    Title
    Stain scores as per Macpherson modification of the Lobene stain index
    Description
    Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration faint stain clearly visible stain, orange to brown (moderate stain) dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: thin line, can be continuous (< 1/3) thick line or band (>1/3, <2/3) covering total area (> 2/3)
    Time Frame
    after four weeks
    Other Pre-specified Outcome Measures:
    Title
    enamel abrasion using atomic force microscopy before and after brushing (Anton Paar - Tosca™ 200 - atomic force microscope, USA.)
    Description
    evaluation the surface roughness of enamel before and after brushing using atomic force microscopy
    Time Frame
    3 minutes equivalent to 2 times a day for one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    IN VIVO: Patients inclusion: Adult male and female patients ≥18 years. 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. Patients exclusion: Uncooperative behavior. Patients allergic to tooth paste material. Patient with history of medical disease, drug therapies or any other serious relevant problem. Pregnant or breastfeeding women. Patients with fixed orthodontic appliances Patients who had professional tooth whitening, within the last six months. Patients who had significant amounts of calculus on facial surfaces of the incisors/canines. Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition. Patients who had advanced periodontal disease on anterior teeth. Xerostomic patients. Patients who used medications which could affect saliva flow or cause staining. Patients who had undergone dental prophylaxis within 8 weeks of screening. Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline. Tooth inclusion: ▪ Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease. Tooth exclusion: Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment). Restorations in anterior teeth, parafunctional habits or tooth sensitivity. Non- vital teeth. IN-VITRO: Teeth inclusion criteria: Intact, free of caries or restorations. No cervical lesions Teeth exclusion criteria: Intrinsically Discolored teeth caused by tetracycline, fluorosis, hyperplasia, endodontic treatment . Restorations in teeth.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iman I ElSayad, Professor
    Phone
    0201005287368
    Email
    iman.sayad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed R El-Bialy, Post Phd
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iman I ElSayad
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohamed R El-Bialy, Post Phd
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes: An In-vitro and In-vivo Trial

    We'll reach out to this number within 24 hrs