- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242639
Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering
Clinical Acceptability of Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering Technique: An up to 7- Year Retrospective Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Objectives: To evaluate the clinical success of laser sintered metal-ceramic restorations throughout several time periods, including the short, medium, and long term.
Materials and methods: Participants who had 3-unit metal-ceramic fixed partial dentures fabricated by laser sintering in the mandibular posterior region between 2014 and 2021 were evaluated. The FDI criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria. The surface luster was assessed and given a score in the field of esthetic properties. The functional parameters were assessed and rated based on fracture, marginal adaptation, radiographic examination, contact point/food impaction, and patient satisfaction. The biological parameters assessed and rated included tooth vitality, periodontal response, mucosa, and oral health. Following the examinations, each parameter was assigned a score ranging from 1 to 5. (1=Clinically excellent/very good, 2=Clinically good, 3=Clinically satisfactory, 4=Clinically unsatisfactory, 5=Clinically poor) Scoring between 1 and 3 was deemed clinically acceptable, whereas scoring 4 or 5 was deemed clinically unacceptable.
Descriptive statistical analysis was performed for all data.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Adana, Turkey, 01250
- Cukurova Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who treated between 2014 and 2021 by prosthodontists at Cukurova University Faculty of Dentistry, Department of Prosthodontics.
- Patients who treated three-unit metal-ceramic fixed partial dentures due to mandibular posterior single tooth deficiency
Exclusion Criteria:
- Patients with any non-vital abutment teeth
- Patients who have severe generalize periodontitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
metal-ceramic FPD
|
clinic and radiographic evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surface luster
Time Frame: 1, 3, 5, and 7 years
|
The surface luster was scored after visual assessment and short air drying.
Score 1 is "Surface luster and surface texture comparable to dental hard tissue/adjacent teeth after air drying" .
Score 2 is "Slightly dull surface luster and/or surface texture with minor deviations, e.g., isolated/small marks, pores, and/or voids detectable compared to dental hard tissue/adjacent teeth after air drying" .
A score of 3 indicates a dull surface with noticeable deviations such as markings, pores, and voids compared to dental hard tissue/adjacent teeth, even without air drying.
Repair is possible".
Score 4 is "Localized, displeasing dull surface luster and/or rough surface texture with substantial deviations/multiple pores/voids detectable compared to dental hard tissue/adjacent teeth which can be repaired" .
Score 5 indicates a dull or rough surface with significant deviations from dental hard tissue and adjacent teeth.
Repair not feasible/reasonable".
|
1, 3, 5, and 7 years
|
Fracture
Time Frame: 1, 3, 5, and 7 years
|
Visually and after short air drying, material fracture and retention were rated.
Score 1 represents complete restoration without deficiencies after air drying.
No cracks, chipping/delamination, or bulk material breakage".
Score 2 says, "Restoration is completely present with minor deficiencies detectable after air drying, e.g., insignificant material chipping or one hairline crack" .
Score 3 indicates restoration with visible defects, such as hairline fractures or material loss (chipping), even without air drying.
Material loss can be addressed by refurbishing if necessary.
Score 4 indicates serious fracture and retention issues, such as chipping/delamination, bulk fracture, or partially loose/lost repair.
Repair is feasible.
Lost indirect restoration, which can be reconstructed, is examined.
Scoring 5 indicates serious deficiencies, such as widespread delamination, many bulk fractures, or mostly lost repair.
No repair possible/reasonable".
|
1, 3, 5, and 7 years
|
Marginal adaptation
Time Frame: 1, 3, 5, and 7 years
|
Marginal gaps are assessed by visual examination, short air drying, and 250 µm probes.
Score 1 indicates "Optimal marginal adaptation of the restoration to tooth hard tissue following air drying.
No little gap detected by gentle probing".
Score 2 indicates small adaption deficiencies after air drying.
A little, superficial gap or ditching.
3 indicates, "Distinct deficiencies of marginal adaptation without air drying: marginal gap(s) or ditching (width <250 µm and/or depth <2 mm)" .
Score 4 indicates serious marginal adaption deficiencies: width ≥250 µm and/or depth ≥2 mm margin gaps.
Partially lost restoration.
Repair is feasible".
Score 5 indicates substantial marginal adaption impairment: width ≥250 µm and/or depth ≥2 mm.
Complete loose/lost restoration.
No repair possible/reasonable".
|
1, 3, 5, and 7 years
|
Radiographic evaluation
Time Frame: 1, 3, 5, and 7 years
|
Restorations with no pathology on radiographs were considered score 1. Restorations with secondary caries, apical pathology, fracture, and tooth/restoration loss were recorded as score 5.
|
1, 3, 5, and 7 years
|
Contact point/Food impaction
Time Frame: 1, 3, 5, and 7 years
|
Proximal contact point was carried out by using visual examination and 25-50-100 µm blades.
Score 1 means, "Ideal contact point: 25-µm metal blade can pass through proximal contact".
Score 2 means, "Slightly weak contact point: 50-µm metal blade can pass through proximal contact".
Score 3 means, "Oversized contact point or excessive material: 25-µm metal blade cannot pass through proximal contact".
Score 4 means, "Severely weak contact point: 100-µm metal blade can pass through proximal contact or unintended interlocked contact point".
Score 5 means, "Severely weak contact point: 100-µm metal blade can easily pass through proximal contact or unintended interlocked contact point (impossible to pass)".
|
1, 3, 5, and 7 years
|
Patient's view
Time Frame: 1, 3, 5, and 7 years
|
Patient comments were attentively listened to and recorded.
Score 1 means, "Entirely satisfied with esthetics and function".
Score 2 means, "Satisfied".
Score 3 means, "Minor criticism but no adverse clinical effects".
Score 4 means, "Desire for improvement".
Score 5 means, "Completely dissatisfied and/or adverse effects".
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1, 3, 5, and 7 years
|
Tooth vitality
Time Frame: 1, 3, 5, and 7 years
|
The teeth were assessed for loss of vitality and assigned scores.
Score 1 means, "Normal vitality".
Score 5 means, "Intense, acute pulpitis or non vital tooth.
Endodontic treatment is necessary and restoration has to be replaced".
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1, 3, 5, and 7 years
|
Periodontal response
Time Frame: 1, 3, 5, and 7 years
|
The presence of plaque, acceptable/unacceptable plaque level and accompanying inflammation, pocket formation, gingival bleeding on probing, and severe acute/chronic periodontitis were all examined to determine the periodontal response and compared to a reference tooth.
Score 1 means, "No plaque, no inflammation, no pockets".
Score 5 means, " Severe / acute gingivitis or periodontitis".
|
1, 3, 5, and 7 years
|
Adjacent mucosa
Time Frame: 1, 3, 5, and 7 years
|
Visual examination was used to assess the condition of the mucosa around the restoration.
Score 1 means, "Healthy mucosa adjacent to restoration".
Score 5 means, "Suspected severe allergic, lichenoid or toxic reaction".
|
1, 3, 5, and 7 years
|
Oral and general health
Time Frame: 1, 3, 5, and 7 years
|
The existence of any irritation and allergic, lichenoid, or toxicological reactions, and to determine the degree of these reactions.
Score 1 means, "No oral or general symptoms".
Score 2 means, "Minor transient symptoms of short duration; local or generalized".
Score 3 means, "Transient symptoms, local and/or general".
Score 4 means, "Persisting local or general symptoms of oral contact stomatitis or lichen planus or allergic reactions.
Intervention necessary but no replacement".
Score 5 means, "Acute/severe local and/or general symptoms".
|
1, 3, 5, and 7 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Selin Çelik Öge
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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