- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491809
Adhesive Cementation Materials and Techniques in Aesthetic Dentistry
Adhesive Cementation Materials and Techniques in Aesthetic Dentistry and Their Effect on the Longevity of Porcelain Veneers
AIM: To determine the most effective cementation method and resin cement material for long term success of esthetical restorations TASKS: 1. Compare Panavia Veneer LC (Kuraray Noritake) cement with universal Panavia V5 (Kuraray Noritake) cement for porcelain veneer cementation in terms of marginal defects and discolouration; 2. Evaluating direct vs indirect restorations after 1-year and 3-year follow up periods in terms of patient satisfaction (evaluated by OES scale).
MATERIAL AND METHODS: Participants: Patients attending the Department of Prosthodontics at the RSU Institute of Stomatology, and willing to improve the aesthetics of front teeth with porcelain veneers. Approx. 30 patients. Inclusion criteria: healthy periodontium, needs 4 veneers, stable occlusion. Exclusion criteria: heavy bruxism, poor oral hygiene, active periodontal inflammation.
Veneer preparations will be done for maxillary anterior teeth approximately 0.5mm deep, involving the whole facial surface and keeping enamel around all borders. For digital impressions of preparations intra-oral scans with intraoral scanner (3Shape TRIOS 5 WIRELESS, Denmark) will be taken. Veneers will be fabricated according to the CAD/CAM technique. This will be a prospective paired design study, i.e., two different composite cements (Panavia V5 and Panavia Veneer LC) will be used for each patient, cementing two veneers with each of the cements.
Data on following variables will be collected:
- Restoration condition (defects related to restoration - ceramic fractures, cracks, loss of retention, discolouration);
- Condition of the abutment teeth (secondary caries, endodontic complications);
- Periodontal condition (probing depth, bleeding on probing, gum recessions);
- Patient satisfaction questionnaire (OES).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mara Gaile, DDS
- Phone Number: +37126010210
- Email: mara.gaile@rsu.lv
Study Contact Backup
- Name: Una Soboleva, Professor
- Phone Number: +37129441268
- Email: una.soboleva@rsu.lv
Study Locations
-
-
-
Riga, Latvia, LV-1007
- Recruiting
- Riga Stradins University
-
Contact:
- Una Soboleva, Professor
- Phone Number: +37129441268
- Email: una.soboleva@rsu.lv
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy periodontium, needs at least 4 veneers, enamel around all veneer borders
Exclusion Criteria:
- heavy bruxism, poor oral hygiene, active periodontal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Porcelain veneers
Patients receiving porcelain veneers as an aesthetic treatment option
|
Teeth preparation, laboratory made porcelain restoration cementation with 2 different cements
Other Names:
|
|
Active Comparator: Direct composite restoration
Patients receiving direct composite injection moulding as an aesthetic treatment option
|
Digital modelling of teeth shapes, restoration with injectable composite directly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with porcelain veneers vs direct composite restorations using OES (orofacial aesthetic scale)
Time Frame: 6 months, 1 year, 3 years
|
OES is a questionnaire with 8 questions regarding orofacial appearance.
The higher the score, the more satisfied the patient is.
7 questions evaluate specific items, and number 8 is an overall assessment.
|
6 months, 1 year, 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of 2 veneer cements in terms of complications and discolouration
Time Frame: 6 months, 1 year, 3 years
|
Data on following variables will be collected for all abutment teeth: Restoration condition (defects related to restoration - ceramic fractures, cracks, loss of retention, discolouration; if present, calculated as a percentage from total restorations); Condition of the abutment teeth (secondary caries, endodontic complications; if present, calculated as a percentage from total restorations); Periodontal condition (probing depth in mm, bleeding on probing present or no; gum recessions in mm); |
6 months, 1 year, 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success and survival of porcelain veneers
Time Frame: 6 months, 1 year, 3 years
|
Success - veneer is present with no biological, technical or aesthetic complications. It is functional, stable, and free from disease. Calculated in percentage from the total count of cemented veneers. Survival - restoration that remains in the mouth and is functional at the end of a specific observation period, regardless of its health status or complications. Calculated in percentage from the total count of the veneers. |
6 months, 1 year, 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christel Larsson, Professor, Malmö University
- Study Director: Una Soboleva, Professor, Riga Stradins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6-DN-20/2/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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