Clinical Assessment of Color Stability and Patient Satisfaction for Polished Versus Glazed Lithium Disilicate Glass Ceramic Restorations and Patient Satisfaction

• ClinicalTrials.gov Identifier: NCT03696641
• Recruitment Status: Unknown
• First Posted: October 5, 2018
• Last Update Posted: October 5, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Rasha Sayed Mosallam, Cairo University

Study Description

Brief Summary:

Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface,Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration

Condition or disease	Intervention/treatment	Phase
Color Change of Lithium Disilicate Crowns	Other: glazed lithium disilicate crowns; Other: polished lithium disilicate crowns	Not Applicable

Detailed Description:

Dental overglaze is consist of colorless glass powder and applied to the fired crown surface to provide a glossy surface. Natural glaze is a vitrified layer that is formed on the surface of the porcelain containing a glass phase when the porcelain is heated to a glazing temperature for a specific time, Adjustment procedure break the production of the glaze layer through a natural glaze or overglaze process and create a rough surface, The color of porcelain restorations is affected by surface roughness because rough surface reflects light irregularly and less than a glazed surface . Therefore, glazing or polishing after adjustment procedures is important to enhance the appearance of the restoration .

Although glazed surfaces appeared whiter, the CIE L* value measured with the specular component excluded (SCE) geometry was lower than that of polished surfaces (28).Several reports have investigated different polishing techniques that support the use of polishing as an alternative for glazing of ceramic restorations .

Polishing can reduce chair time, eliminates laboratory procedures, infection control may be obtained . Polishing is also important for the porcelain surface for esthetic so several different techniques have been described for repolishing porcelain surfaces in the mouth .

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: participant, outcome assessor double blind
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of Color Stability and Patient Satisfaction for Polished Versus Glazed Lithium Disilicate Glass Ceramic Restorations and Patient Satisfaction
• Estimated Study Start Date: November 1, 2018
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: November 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: glazed IPS e.max; lithium disilicate glazed crowns that proved to have a good color stability	Other: glazed lithium disilicate crowns; glazing of IPS e.max crowns; Other Name: glazed IPS e.max; Other: polished lithium disilicate crowns; polishing of IPS e.max crowns; Other Name: polished IPS e.max
Experimental: polished IPS e.max; polished lithium disilicate crowns with the polishing kit	Other: glazed lithium disilicate crowns; glazing of IPS e.max crowns; Other Name: glazed IPS e.max; Other: polished lithium disilicate crowns; polishing of IPS e.max crowns; Other Name: polished IPS e.max

Outcome Measures

Primary Outcome Measures :

1. color stability [ Time Frame: one year ]
   L* a* b* values and ∆E

Secondary Outcome Measures :

1. patient satisfaction [ Time Frame: one year ]
   patient satisfaction through a questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All subjects are required to be:

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Physically and psychologically able to tolerate conventional restorative procedures
  3. have no active periodontal or pulpal diseases, have teeth with good restorations
  4. Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

• 1. Patients in the growth stage with partially erupted teeth 2. Patients with poor oral hygiene and motivation 3. Pregnant women's 4. Psychiatric problems or unrealistic expectations

Contacts and Locations

Contacts

Contact: rasha sayed MOSALLAM, MDS; 01004222871; rashamosallam@yahoo.com

Contact: Hesham katamish, professor; 01222102001

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Rasha Sayed Mosallam, Assistant lecturer- fixed prosthodontics department, Cairo University
• ClinicalTrials.gov Identifier: NCT03696641
• Other Study ID Numbers: CEBD-CU-2018-09-25
• First Posted: October 5, 2018
• Last Update Posted: October 5, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lithium Carbonate; Antidepressive Agents; Psychotropic Drugs; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs