NCT02846116

Brief Summary

The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium disilicate on patient satisfaction combined with shade matching.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

July 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

July 19, 2016

Last Update Submit

October 15, 2016

Conditions

Keywords

all ceramic crownLithium disilicatee-maxvita suprinity

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)

    1 year

Secondary Outcomes (1)

  • Shade matchUsing the modified United States Public Health Service criteria (Modified USPHS)- categorical

    1 year

Study Arms (2)

lithium disilicate

ACTIVE COMPARATOR

The intervention will be: Prosthetic crown

Other: Prosthetic crown

Vita suprinity

ACTIVE COMPARATOR

The intervention will be: Prosthetic crown

Other: Prosthetic crown

Interventions

Also known as: all ceramic crown
Vita suprinitylithium disilicate

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  • Patients able physically and psychologically to tolerate conventional restorative procedures.
  • Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
  • Patients with teeth problems indicated for full coverage restoration (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  • Patients with root canal treated teeth requiring full coverage restorations.
  • Patients willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
  • Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).
  • Patients have no opposite occluding dentition in the area intended for restoration.
  • Patients suffer from parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Tin-Oo MM, Saddki N, Hassan N. Factors influencing patient satisfaction with dental appearance and treatments they desire to improve aesthetics. BMC Oral Health. 2011 Feb 23;11:6. doi: 10.1186/1472-6831-11-6.

    PMID: 21342536BACKGROUND
  • Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.

    PMID: 24980739BACKGROUND
  • John MT, Slade GD, Szentpetery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11.

    PMID: 15543905BACKGROUND
  • Grossmann AC, Hassel AJ, Schilling O, Lehmann F, Koob A, Rammelsberg P. Treatment with double crown-retained removable partial dentures and oral health-related quality of life in middle- and high-aged patients. Int J Prosthodont. 2007 Nov-Dec;20(6):576-8.

    PMID: 18069364BACKGROUND
  • Corciolani G, Vichi A, Louca C, Ferrari M. Color match of two different ceramic systems to selected shades of one shade guide. J Prosthet Dent. 2011 Mar;105(3):171-6. doi: 10.1016/S0022-3913(11)60025-5.

    PMID: 21356409BACKGROUND
  • Ishikawa-Nagai S, Yoshida A, Sakai M, Kristiansen J, Da Silva JD. Clinical evaluation of perceptibility of color differences between natural teeth and all-ceramic crowns. J Dent. 2009;37 Suppl 1:e57-63. doi: 10.1016/j.jdent.2009.04.004. Epub 2009 Apr 18.

    PMID: 19423209BACKGROUND
  • Al-Wahadni A, Ajlouni R, Al-Omari Q, Cobb D, Dawson D. Shade-match perception of porcelain-fused-to-metal restorations: a comparison between dentist and patient. J Am Dent Assoc. 2002 Sep;133(9):1220-5; quiz 1260-1. doi: 10.14219/jada.archive.2002.0363.

    PMID: 12356253BACKGROUND
  • Etman MK, Woolford MJ. Three-year clinical evaluation of two ceramic crown systems: a preliminary study. J Prosthet Dent. 2010 Feb;103(2):80-90. doi: 10.1016/S0022-3913(10)60010-8.

    PMID: 20141812BACKGROUND
  • Dr Rupal J Shah1. A Study of Patient Satisfaction with Maxillary Anterior Teeth Restorations and Desirable Esthetic Treatment Options\n. IOSR J. Dent. Med. Sci. 13, 79-86 (2014).

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Amina Zaki, Professor

    Faculty of Oral and Dental Medicine- Cairo University

    STUDY DIRECTOR

Central Study Contacts

Sameh Sh Abou-Steit, Master

CONTACT

Jylan El Guindy, Professor

CONTACT

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
Principal investigator, Assisstant lecturer

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 27, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10