Crowns (MeSH Unique ID: D003442), Single Tooth Clinical Trial
Official title:
Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial
| Verified date | July 2020 |
| Source | Hacettepe University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Based on these developments, in every passing days new ceramic materials has been added to dental market. The aim of the present study was evaluating clinical results of single-tooth ceramic crowns in the posterior region produced from three different monolithic ceramic materials.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | November 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years old - Individuals who have signed the informed consent form - Periodontally stable patients - Having devital teeth need to be restored in the posterior region - Having natural dentition or minimally invasive restoration against the restored tooth. Exclusion Criteria: - Diagnosed patients with temporomandibular joint problems - Insufficient supportive tooth tissue for restoration |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hacettepe University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival rate and success (changes over time) | 12 crowns were made from each group of three different ceramics: ZRGC, LDGC and RIGC. Thereafter, the restorations was evaluated in terms of any failure or loss of the restoration at any follow-up (6th and 12th months) periods. The results were obtained proportionally in percent (%). | 1 year (Baseline to 12 months) | |
| Primary | Prosthetic evaluation changes | As recorded at the baseline (0), each restoration was assessed according to the modified the United States Public Health Service (USPHS) Ryge Criteria for prosthetic evaluation by a calibrated prosthodontics.USPHS criteria is based on the following ratings: Color match (Alpha,Bravo, Charlie), cavosurface marginal discoloration (Alpha,Bravo, Charlie), secondary caries (Alpha,Bravo), anatomic contour (Alpha,Bravo, Charlie), marginal integrity (Alpha,Bravo, Charlie), surface texture (Alpha,Bravo, Charlie) and gross fracture (Alpha,Bravo, Charlie). | 1 year (Baseline to 12 months) | |
| Primary | Periodontal evaluation changes | Probing depth(PD): Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket (mm). Clinical attachment level(CAL): The loss of CAL were measured and calculated by measuring recession and subtracting the periodontal probing depth (mm). Gingival bleeding time index(GBTI): The probe were swiped at apical portion of the gingival crevice from line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial and distal (unit/tooth). Plaque index(PI, according to Silness and Löe, 1964): The total mean PI is the sum of the individual scores divided by the number of investigated sites. The thickness and extension of plaque were assessed (unit/tooth). Gingival index(GI, according to Löe, 1967): The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4 (unit/tooth). |
1 year (Baseline to 12 months) |