Enamel Abrasion and Stain Removal Efficacy

Discoloration, Tooth Clinical Trial

Official title:

Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05619315
• Other study ID #: Charcoal based whitening
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Mohamed Osama Metwally
• Phone: 00201008488587
• Email: Mohamedelbadry[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enamel abrasion and stain removal efficacy of two whitening toothpastes

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: October 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abrasion
• Discoloration, Tooth
• Tooth Discoloration

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (22)

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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. — View 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. Review. — View 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. Review. — View Citation

Collins LZ, Naeeni M, Schäfer 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. — View 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. — View 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. — View Citation

Hattab FN, Qudeimat MA, al-Rimawi HS. Dental discoloration: an overview. J Esthet Dent. 1999;11(6):291-310. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Macpherson LM, Stephen KW, Joiner A, Schäfer F, Huntington E. Comparison of a conventional and modified tooth stain index. J Clin Periodontol. 2000 Nov;27(11):854-9. — View Citation

Özkan P, Kansu G, Özak 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. — View 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. — View 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. — View Citation

Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. Review. — View Citation

Wülknitz P. Cleaning power and abrasivity of European toothpastes. Adv Dent Res. 1997 Nov;11(4):576-9. — View 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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stain score	mcpherson modification of the stain index and area x intensity	T0: Baseline
Primary	Stain score	mcpherson modification of the stain index and area x intensity	T1: 4 weeks
Secondary	Surface roughness	Atomic Force Microscopy	T0: Baseline
Secondary	Surface roughness	Atomic Force Microscopy	T1: 3 minutes equivalent to 2 times a day for one month.