Enamel Abrasion and Stain Removal Efficacy

NCT05619315 | Unknown

• 1 other identifier: Charcoal based whitening
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Enamel abrasion and stain removal efficacy of two whitening toothpastes

Conditions

Abrasion; Discoloration, Tooth

Keywords

abrasion; toothpaste; stain; whitening

Outcome Measures

Primary Outcomes (2)

• Stain score

  mcpherson modification of the stain index and area x intensity

  T0: Baseline

• Stain score

  mcpherson modification of the stain index and area x intensity

  T1: 4 weeks

Secondary Outcomes (2)

• Surface roughness

  T0: Baseline

• Surface roughness

  T1: 3 minutes equivalent to 2 times a day for one month.

Study Arms (2)

Charcoal -based whitening toothpaste.

EXPERIMENTAL

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

Calcium carbonate /perlite containing whitening toothpaste.

ACTIVE COMPARATOR

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.

Interventions

Charcoal -based whitening toothpaste OTHER

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.

Charcoal -based whitening toothpaste.

Calcium carbonate /perlite containing whitening toothpaste. OTHER

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.

Calcium carbonate /perlite containing whitening toothpaste.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In vivo:
• 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.
• Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
• In vitro:
• Intact, free of caries or restorations.
• No cervical lesions .

You may not qualify if:

• In vivo:
• 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
• Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment).

Sponsors & Collaborators

• Cairo University: lead

Related Publications (22)

• 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.

  PMID: 23210419 BACKGROUND

• 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.

  PMID: 11325156 BACKGROUND

• 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.

  PMID: 18622478 BACKGROUND

• 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.

  PMID: 21356017 BACKGROUND

• 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.

  PMID: 16004250 BACKGROUND

• 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.

  PMID: 25046241 BACKGROUND

• 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.

  PMID: 25134963 BACKGROUND

• 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.

  PMID: 12892441 BACKGROUND

• 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.

  PMID: 22746180 BACKGROUND

• 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.

  PMID: 24929591 BACKGROUND

• 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.

  PMID: 22747485 BACKGROUND

• 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.

  PMID: 21977958 BACKGROUND

• 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.

  PMID: 15794456 BACKGROUND

• 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.

  PMID: 16972390 BACKGROUND

• 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.

  PMID: 28599961 BACKGROUND

• 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.

  PMID: 27737352 BACKGROUND

• 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.

  PMID: 20562012 BACKGROUND

• Wulknitz P. Cleaning power and abrasivity of European toothpastes. Adv Dent Res. 1997 Nov;11(4):576-9. doi: 10.1177/08959374970110042701.

  PMID: 9470519 BACKGROUND

• 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.

  PMID: 18646364 BACKGROUND

• 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.

  PMID: 11073329 BACKGROUND

• 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.

  PMID: 18173893 BACKGROUND

• 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.

  PMID: 10825865 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Iman Ibrahim El Sayad, prof

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Osama Metwally

CONTACT

00201008488587; Mohamedelbadry@dentistry.cu.edu.eg

Mohamed Refaat El-Bialy, phd

CONTACT

00201202552666; mohamed.refaat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bachelor

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 16, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share