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Repeatability Of A Calibrated Digital Spectrophotometer For Dental Shade Evaluation In Current, Former And Never Smokers Study Protocol

Journal: MedRxiv


Despite the negative impact of cigarette smoking on oral health and teeth appearance, there is no data available on dental shade changes in smokers who quit smoking. Dental discoloration caused by smoking may be permanent, with minimal restoration after stopping smoking. If this is valid, former smokers can show dental shade values equivalent to those of current smokers.

The aim of this study is to compare the dental shade assessment by digital spectrophotometry (VITA Easyshade V) in current, former and never smokers and to verify the short (7 days) and long-term (30 days) repeatability of these measurements.

Confirmation of good reproducibility of VITA Easyshade V with clear objective discrimination of dental shade measurements among current, former, and never smokers will improve the power of this measurement giving more confidence in clinical research findings of dental shades in these populations.

It is also anticipated that results from the study will expand the application of this measurements to include medical and regulatory research applied to combustion-free tobacco products (e.g. e-cigarettes, heated tobacco products, oral tobacco/nicotine products, etc.), smoking cessation medications, and to consumer care product for oral hygiene and dental aesthetics.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

The study was not registered in ClinicalTrials.gov considering that is a pilot study, parts of a larger project with ID: NCT04649645

Funding Statement

This investigator initiated research is supported by a grant from the Foundation for a Smoke free World (FSFW)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.


The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Comitato Etico Catania 2 n. 73/2020/CECT2

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.


I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).


I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.