15 Years Control of Fiber Reenforced Composite Fixed Partial Dentures

NCT02764463 | Unknown

• 1 other identifier: FRCPDS15Y
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective clinical study evaluated the performance of indirect, posterior occlusal-retained, fiber-reinforced-composite restorations. Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years old ( 33 male, 25 female) received 65 FCRFPD prosthesis. All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and thereafter annually up to 15 years. The evaluation protocol involved technical (chipping, debonding or fracture of tooth/restoration) and biological failures (caries).

Conditions

Prosthodontics E06.780

Keywords

Fiber Reinforced Composites; Resin cements; Survival

Outcome Measures

Primary Outcomes (4)

• Debonding of restoration

  According to USPHS criteria

  15 Years

• Fracture of Tooth

  According to USPHS criteria

  15 Years

• Fracture of Restorations

  According to USPHS criteria

  15 Years

• Chipping of restoration

  According to USPHS criteria

  15 Years

Secondary Outcomes (1)

• Secondary caries of the tooth

  15 Years

Study Arms (1)

FRCFPDs

OTHER

Fiber reenforced Composite Fixed Partial Dentures

Device: Fiber Reinforced Composite Fixed Partial Dentures

Interventions

Fiber Reinforced Composite Fixed Partial Dentures DEVICE

All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, , liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer)

Also known as: FRCPDs

FRCFPDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects were required to be at least 18 years old, able to read and sign the informed consent document
• Physically and psychologically able to tolerate conventional restorative procedures
• Having no active periodontal or pulpal diseases
• Having no primary caries
• Not allergic to resin-based materials
• Not pregnant or nursing
• Having antagonist teeth opposing the FRC FDP to be restored
• Willing to return for follow-up examinations as outlined by the investigators.

You may not qualify if:

• Patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.

Sponsors & Collaborators

• BNM Clinic and Research: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 1999
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2020
• Last Updated: July 26, 2016

Record last verified: 2016-07