NCT04348773

Brief Summary

The aim of this study was to investigate any change in tooth color resulting from dehydration resulted from rubber dam application and the time required for any change to return to baseline and to investigate the nature of change and areas of the teeth most affected.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 9, 2020

Last Update Submit

April 15, 2020

Conditions

Tooth Shade

Outcome Measures

Primary Outcomes (1)

  • Clinical spectrophotometric assessment of tooth shade change

    Using Easyshade V clinical spectrophotometer

    10, 30, 40 and 60 minutes

Study Arms (2)

Dehydration

EXPERIMENTAL
Procedure: Dehydration

Rehydration

EXPERIMENTAL
Procedure: Rehydration

Interventions

DehydrationPROCEDURE

Dehydration of the natural tooth by tooth isolation

Dehydration
RehydrationPROCEDURE

Rehydration

Rehydration

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with unrestored intact maxillary central incisors with no tooth bleaching performed during the previous year.

You may not qualify if:

  • Presence of any restorations or fixed orthodontic appliance or any fixed retainers on central incisors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo Univerity

Cairo, 11553, Egypt

RECRUITING

Related Publications (14)

  • Samorodnitzky-Naveh GR, Geiger SB, Levin L. Patients' satisfaction with dental esthetics. J Am Dent Assoc. 2007 Jun;138(6):805-8. doi: 10.14219/jada.archive.2007.0269.

    PMID: 17545270BACKGROUND

  • Burki Z, Watkins S, Wilson R, Fenlon M. A randomised controlled trial to investigate the effects of dehydration on tooth colour. J Dent. 2013 Mar;41(3):250-7. doi: 10.1016/j.jdent.2012.11.009. Epub 2012 Nov 14.

    PMID: 23160038BACKGROUND

  • Bazos P, Magne P. Bio-Emulation: biomimetically emulating nature utilizing a histoanatomic approach; visual synthesis. Int J Esthet Dent. 2014 Autumn;9(3):330-52.

    PMID: 25126615BACKGROUND

  • Hariri I, Sadr A, Nakashima S, Shimada Y, Tagami J, Sumi Y. Estimation of the enamel and dentin mineral content from the refractive index. Caries Res. 2013;47(1):18-26. doi: 10.1159/000342416. Epub 2012 Oct 10.

    PMID: 23051596BACKGROUND

  • Hariri I, Sadr A, Shimada Y, Tagami J, Sumi Y. Effects of structural orientation of enamel and dentine on light attenuation and local refractive index: an optical coherence tomography study. J Dent. 2012 May;40(5):387-96. doi: 10.1016/j.jdent.2012.01.017. Epub 2012 Feb 7.

    PMID: 22342164BACKGROUND

  • Joiner A. Tooth colour: a review of the literature. J Dent. 2004;32 Suppl 1:3-12. doi: 10.1016/j.jdent.2003.10.013.

    PMID: 14738829BACKGROUND

  • Paul S, Peter A, Pietrobon N, Hammerle CH. Visual and spectrophotometric shade analysis of human teeth. J Dent Res. 2002 Aug;81(8):578-82. doi: 10.1177/154405910208100815.

    PMID: 12147751BACKGROUND

  • Brewer JD, Wee A, Seghi R. Advances in color matching. Dent Clin North Am. 2004 Apr;48(2):v, 341-58. doi: 10.1016/j.cden.2004.01.004.

    PMID: 15172604BACKGROUND

  • Douglas RD, Steinhauer TJ, Wee AG. Intraoral determination of the tolerance of dentists for perceptibility and acceptability of shade mismatch. J Prosthet Dent. 2007 Apr;97(4):200-8. doi: 10.1016/j.prosdent.2007.02.012.

    PMID: 17499089BACKGROUND

  • Stevenson B. Current methods of shade matching in dentistry: a review of the supporting literature. Dent Update. 2009 Jun;36(5):270-2, 274-6. doi: 10.12968/denu.2009.36.5.270.

    PMID: 19585849BACKGROUND

  • Dozic A, Kleverlaan CJ, El-Zohairy A, Feilzer AJ, Khashayar G. Performance of five commercially available tooth color-measuring devices. J Prosthodont. 2007 Mar-Apr;16(2):93-100. doi: 10.1111/j.1532-849X.2007.00163.x.

    PMID: 17362418BACKGROUND

  • Russell MD, Gulfraz M, Moss BW. In vivo measurement of colour changes in natural teeth. J Oral Rehabil. 2000 Sep;27(9):786-92. doi: 10.1046/j.1365-2842.2000.00610.x.

    PMID: 11012854BACKGROUND

  • Meng Z, Yao XS, Yao H, Liang Y, Liu T, Li Y, Wang G, Lan S. Measurement of the refractive index of human teeth by optical coherence tomography. J Biomed Opt. 2009 May-Jun;14(3):034010. doi: 10.1117/1.3130322.

    PMID: 19566303BACKGROUND

  • Suliman S, Sulaiman TA, Olafsson VG, Delgado AJ, Donovan TE, Heymann HO. Effect of time on tooth dehydration and rehydration. J Esthet Restor Dent. 2019 Mar;31(2):118-123. doi: 10.1111/jerd.12461. Epub 2019 Feb 23.

    PMID: 30801926BACKGROUND

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Ahmed El Zohairy, PhD

    Head of Operative department

    STUDY DIRECTOR

Central Study Contacts

Sameh Abou-Steit, PhD

CONTACT

01001891010samehabousteit@gmail.com

Ahmed El Zohairy, PhD

CONTACT

01227848002aelzohairy@gmail.com

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
Sameh Abou-Steit

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 16, 2020

Study Start

April 15, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

EG(1)