Metal-ceramic Fixed Partial Dentures Fabricated With Laser Sintering

NCT06242639 | Completed

• 1 other identifier: Selin Çelik Öge
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Survival, Prosthesis; Clinical Acceptability, Prosthesis

Keywords

metal-ceramic restorations; laser sintering

Outcome Measures

Primary Outcomes (10)

• Surface luster

  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

  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

  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

  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

  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

  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".

  1, 3, 5, and 7 years

• Tooth vitality

  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".

  1, 3, 5, and 7 years

• Periodontal response

  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

  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

  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

Study Arms (1)

metal-ceramic FPD

Other: Clinical examination

Interventions

Clinical examination OTHER

clinic and radiographic evaluation

metal-ceramic FPD

Eligibility Criteria

• Age: 29 Years - 69 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Includes all patients treated by Cukurova University Faculty of Dentistry, Department of Prosthodontics, with laser sintered three-unit metal-ceramic FPD for mandibular posterior single tooth deficiency between 2014 and 2021.

You may qualify if:

• 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

You may not qualify if:

• Patients with any non-vital abutment teeth
• Patients who have severe generalize periodontitis

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova Univeristy

Adana, 01250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 5, 2024
• Study Start: June 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: February 1, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

TU (1)