Follow-up examination of three-unit anterior and premolar bridges made of IPS e.max CAD LT over a period of up to 15 years (Treatment and 5-year study period completed)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030779

Enrollment

Registered

2023-03-23

Start date

2023-04-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

three-unit anterior and premolar fixed dental prostheses

Interventions

Group 1: Pure follow-up of three-unit anterior and premolar bridges made of IPS e.max CAD LT. No control group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients included in the study "Three-unit CAD/CAM-generated lithium disilicate FDPs after a mean observation time of 46 months" who: - sign the informed consent form for the current study - continue to be in good health according to the ASA Physical Status Classification System 1 or 2 (ASA 2010).

Exclusion criteria

Exclusion criteria: - Serious general illnesses acquired in the meantime, for which a dental diagnosis would represent a potential risk, e.g. immunosuppressed patients or patients for whom antibiotic prophylaxis is necessary. - patients who are now psychologically incapacitated - patients who are now incapable of giving consent - Patients who are now institutionalised by court order or by order of the authorities.

Design outcomes

Primary

Measure	Time frame
One-time follow-up after up to 15 years of the anterior and premolar bridges from the study "Three-unit CAD/CAM-generated lithium disilicate FDPs after a mean observation time of 46 months", in which treatment phase and the specified follow-up period have been completed. The main objective of this follow-up study is to verify the long-term behavior of IPS e.max CAD LT for three-unit anterior and premolar bridges. Fractures and significant spalling (in the case of a partial reduction and subsequent veneering with IPS e.max Ceram) as well as decementations are determined as the main target parameters that allow the success to be assessed. The measurements relevant for the main target parameters are recorded during the follow-up examination. If the time is after completion of the 5-year examination period and before the start of this follow-up examination, the time at which the patient visited the practice or clinic with the complaints relating to the restoration is noted.	—

Measure

Time frame

One-time follow-up after up to 15 years of the anterior and premolar bridges from the study "Three-unit CAD/CAM-generated lithium disilicate FDPs after a mean observation time of 46 months", in which treatment phase and the specified follow-up period have been completed. The main objective of this follow-up study is to verify the long-term behavior of IPS e.max CAD LT for three-unit anterior and premolar bridges. Fractures and significant spalling (in the case of a partial reduction and subsequent veneering with IPS e.max Ceram) as well as decementations are determined as the main target parameters that allow the success to be assessed. The measurements relevant for the main target parameters are recorded during the follow-up examination. If the time is after completion of the 5-year examination period and before the start of this follow-up examination, the time at which the patient visited the practice or clinic with the complaints relating to the restoration is noted.

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Secondary

Measure	Time frame
Secondary target parameters were defined as the presence of surface roughness, one or more cracks, tooth vitality, hypersensitivity, discoloration, marginal gap and caries with the ratings "0 = negative" and "1 = positive". In addition, an occlusion analysis is performed. For this purpose, it is evaluated for each tooth of the bridge whether there is no guidance at all (0), sole guidance (1) or group guidance (2). Furthermore, the degree of looseness (0-III), the probing depth (in mm), the plaque index and gingival index according to Silness and Löe, and the papilla bleeding index according to Saxer and Mühlemann are determined. Both patient and dentist evaluate the esthetics with school grades (1-6). All parameters are listed in the documentation forms (CRFs) provided to the follow-up examiners. Definition of survival rate: All restorations which remain in situ in function are considered to be surviving restorations. Definition success rate: All restorations that do not experience biological and technical complications are considered complication-free.	—

Measure

Time frame

Secondary target parameters were defined as the presence of surface roughness, one or more cracks, tooth vitality, hypersensitivity, discoloration, marginal gap and caries with the ratings "0 = negative" and "1 = positive". In addition, an occlusion analysis is performed. For this purpose, it is evaluated for each tooth of the bridge whether there is no guidance at all (0), sole guidance (1) or group guidance (2). Furthermore, the degree of looseness (0-III), the probing depth (in mm), the plaque index and gingival index according to Silness and Löe, and the papilla bleeding index according to Saxer and Mühlemann are determined. Both patient and dentist evaluate the esthetics with school grades (1-6). All parameters are listed in the documentation forms (CRFs) provided to the follow-up examiners. Definition of survival rate: All restorations which remain in situ in function are considered to be surviving restorations. Definition success rate: All restorations that do not experience biological and technical complications are considered complication-free.

—

Countries

Germany

Contacts

Public ContactMartin Homa

Klinik für Zahnärztliche Prothetik und Biomaterialien, Zentrum für Implantologie

mahoma@ukaachen.de+49 241 80-89427

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026