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NCT Number: NCT06242639

Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering

The aim of this retrospective clinical study was to evaluate the clinical acceptability of metal-ceramic fixed partial dentures (FPD) manufactured utilizing direct metal laser-sintering technology, taking into account the short-term, medium-term, and long-term outcomes. The Federation Dentaire International (FDI) World Dental Federation criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria

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Key information

Age range

29 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova Univeristy

Adana, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical examination

Other

clinic and radiographic evaluation

Primary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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.

  5. 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)".

  6. 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".

  7. 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".

  8. 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".

  9. 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".

  10. 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".

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Clinical Acceptability of Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering Technique: An up to 7- Year Retrospective Clinical Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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