search
Back to results

Enamel Abrasion and Stain Removal Efficacy

Primary Purpose

Abrasion, Discoloration, Tooth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Charcoal -based whitening toothpaste
Calcium carbonate /perlite containing whitening toothpaste.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abrasion focused on measuring abrasion, toothpaste, stain, whitening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion 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. 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: Intact, free of caries or restorations. No cervical lesions . Exclusion Criteria: In vivo: 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 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 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

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Stain score
    mcpherson modification of the stain index and area x intensity
    Stain score
    mcpherson modification of the stain index and area x intensity

    Secondary Outcome Measures

    Surface roughness
    Atomic Force Microscopy
    Surface roughness
    Atomic Force Microscopy

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    November 9, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05619315
    Brief Title
    Enamel Abrasion and Stain Removal Efficacy
    Official Title
    Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    October 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
    Enamel abrasion and stain removal efficacy of two whitening toothpastes
    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
    Abrasion, Discoloration, Tooth
    Keywords
    abrasion, toothpaste, stain, whitening

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Charcoal -based whitening toothpaste.
    Arm Type
    Experimental
    Arm 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. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
    Arm Title
    Calcium carbonate /perlite containing whitening toothpaste.
    Arm Type
    Active Comparator
    Arm 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. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
    Intervention Type
    Other
    Intervention Name(s)
    Charcoal -based whitening toothpaste
    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. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
    Intervention Type
    Other
    Intervention Name(s)
    Calcium carbonate /perlite containing whitening toothpaste.
    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. After 1 month, re-evaluation of the stains will be performed and the data will be recorded.
    Primary Outcome Measure Information:
    Title
    Stain score
    Description
    mcpherson modification of the stain index and area x intensity
    Time Frame
    T0: Baseline
    Title
    Stain score
    Description
    mcpherson modification of the stain index and area x intensity
    Time Frame
    T1: 4 weeks
    Secondary Outcome Measure Information:
    Title
    Surface roughness
    Description
    Atomic Force Microscopy
    Time Frame
    T0: Baseline
    Title
    Surface roughness
    Description
    Atomic Force Microscopy
    Time Frame
    T1: 3 minutes equivalent to 2 times a day for one month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion 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. 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: Intact, free of caries or restorations. No cervical lesions . Exclusion Criteria: In vivo: 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 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 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
    Mohamed Osama Metwally
    Phone
    00201008488587
    Email
    Mohamedelbadry@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Refaat El-Bialy, phd
    Phone
    00201202552666
    Email
    mohamed.refaat@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iman Ibrahim El Sayad, prof
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23210419
    Citation
    Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S. Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth. J Clin Dent. 2012;23(3):86-91.
    Results Reference
    background
    PubMed Identifier
    11325156
    Citation
    Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. doi: 10.1038/sj.bdj.4800959.
    Results Reference
    background
    PubMed Identifier
    18622478
    Citation
    Lima DA, Silva AL, Aguiar FH, Liporoni PC, Munin E, Ambrosano GM, Lovadino JR. In vitro assessment of the effectiveness of whitening dentifrices for the removal of extrinsic tooth stains. Braz Oral Res. 2008 Apr-Jun;22(2):106-11. doi: 10.1590/s1806-83242008000200003.
    Results Reference
    background
    PubMed Identifier
    21356017
    Citation
    Kalyana P, Shashidhar A, Meghashyam B, Sreevidya KR, Sweta S. Stain removal efficacy of a novel dentifrice containing papain and Bromelain extracts--an in vitro study. Int J Dent Hyg. 2011 Aug;9(3):229-33. doi: 10.1111/j.1601-5037.2010.00473.x. Epub 2010 Jul 1.
    Results Reference
    background
    PubMed Identifier
    16004250
    Citation
    Collins LZ, Naeeni M, Schafer F, Brignoli C, Schiavi A, Roberts J, Colgan P. The effect of a calcium carbonate/perlite toothpaste on the removal of extrinsic tooth stain in two weeks. Int Dent J. 2005;55(3 Suppl 1):179-82. doi: 10.1111/j.1875-595x.2005.tb00056.x.
    Results Reference
    background
    PubMed Identifier
    25046241
    Citation
    Patil PA, Ankola AV, Hebbal MI, Patil AC. Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial. Int J Dent Hyg. 2015 Feb;13(1):25-9. doi: 10.1111/idh.12090. Epub 2014 Jul 21.
    Results Reference
    background
    PubMed Identifier
    25134963
    Citation
    Zafar MS, Ahmed N. Nanomechanical characterization of exfoliated and retained deciduous incisors. Technol Health Care. 2014;22(6):785-93. doi: 10.3233/THC-140852.
    Results Reference
    background
    PubMed Identifier
    12892441
    Citation
    Litonjua LA, Andreana S, Bush PJ, Tobias TS, Cohen RE. Noncarious cervical lesions and abfractions: a re-evaluation. J Am Dent Assoc. 2003 Jul;134(7):845-50. doi: 10.14219/jada.archive.2003.0282.
    Results Reference
    background
    PubMed Identifier
    22746180
    Citation
    Johannsen G, Tellefsen G, Johannsen A, Liljeborg A. The importance of measuring toothpaste abrasivity in both a quantitative and qualitative way. Acta Odontol Scand. 2013 May-Jul;71(3-4):508-17. doi: 10.3109/00016357.2012.696693. Epub 2012 Jul 2.
    Results Reference
    background
    PubMed Identifier
    24929591
    Citation
    Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.
    Results Reference
    background
    PubMed Identifier
    22747485
    Citation
    Ozkan P, Kansu G, Ozak ST, Kurtulmus-Yilmaz S, Kansu P. Effect of bleaching agents and whitening dentifrices on the surface roughness of human teeth enamel. Acta Odontol Scand. 2013 May-Jul;71(3-4):488-97. doi: 10.3109/00016357.2012.696691. Epub 2012 Jul 2.
    Results Reference
    background
    PubMed Identifier
    21977958
    Citation
    Barbieri GM, Mota EG, Rodrigues-Junior SA, Burnett LH Jr. Effect of whitening dentifrices on the surface roughness of commercial composites. J Esthet Restor Dent. 2011 Oct;23(5):338-45. doi: 10.1111/j.1708-8240.2011.00426.x. Epub 2011 May 9.
    Results Reference
    background
    PubMed Identifier
    15794456
    Citation
    Gerlach RW, Barker ML, Tucker HL. Clinical response of three whitening products having different peroxide delivery: comparison of tray, paint-on gel, and dentifrice. J Clin Dent. 2004;15(4):112-7.
    Results Reference
    background
    PubMed Identifier
    16972390
    Citation
    Joiner A. Review of the extrinsic stain removal and enamel/dentine abrasion by a calcium carbonate and perlite containing whitening toothpaste. Int Dent J. 2006 Aug;56(4):175-80. doi: 10.1111/j.1875-595x.2006.tb00091.x.
    Results Reference
    background
    PubMed Identifier
    28599961
    Citation
    Brooks JK, Bashirelahi N, Reynolds MA. Charcoal and charcoal-based dentifrices: A literature review. J Am Dent Assoc. 2017 Sep;148(9):661-670. doi: 10.1016/j.adaj.2017.05.001. Epub 2017 Jun 7.
    Results Reference
    background
    PubMed Identifier
    27737352
    Citation
    Pintado-Palomino K, Vasconcelos CV, Silva RJ, Fressatti AL, Motta BJ, Pires-DE-Souza FC, Tirapelli C. Effect of whitening dentifrices: a double-blind randomized controlled trial. Braz Oral Res. 2016 Oct 10;30(1):e82. doi: 10.1590/1807-3107BOR-2016.vol30.0082.
    Results Reference
    background
    PubMed Identifier
    20562012
    Citation
    Joiner A. Whitening toothpastes: a review of the literature. J Dent. 2010;38 Suppl 2:e17-24. doi: 10.1016/j.jdent.2010.05.017. Epub 2010 May 24.
    Results Reference
    background
    PubMed Identifier
    9470519
    Citation
    Wulknitz P. Cleaning power and abrasivity of European toothpastes. Adv Dent Res. 1997 Nov;11(4):576-9. doi: 10.1177/08959374970110042701.
    Results Reference
    background
    PubMed Identifier
    18646364
    Citation
    Joiner A, Philpotts CJ, Alonso C, Ashcroft AT, Sygrove NJ. A novel optical approach to achieving tooth whitening. J Dent. 2008;36 Suppl 1:S8-14. doi: 10.1016/j.jdent.2008.02.005.
    Results Reference
    background
    PubMed Identifier
    11073329
    Citation
    Macpherson LM, Stephen KW, Joiner A, Schafer F, Huntington E. Comparison of a conventional and modified tooth stain index. J Clin Periodontol. 2000 Nov;27(11):854-9. doi: 10.1034/j.1600-051x.2000.027011854.x.
    Results Reference
    background
    PubMed Identifier
    18173893
    Citation
    Black MA, Bayne SC, Peterson CA. Effect of power toothbrushing on simulated wear of dental cement margins. J Dent Hyg. 2007 Fall;81(4):79. Epub 2007 Oct 1.
    Results Reference
    background
    PubMed Identifier
    10825865
    Citation
    Hattab FN, Qudeimat MA, al-Rimawi HS. Dental discoloration: an overview. J Esthet Dent. 1999;11(6):291-310. doi: 10.1111/j.1708-8240.1999.tb00413.x.
    Results Reference
    background

    Learn more about this trial

    Enamel Abrasion and Stain Removal Efficacy

    We'll reach out to this number within 24 hrs