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Clinical outcomes of one-piece or segmented fixed prosthesis supported by six implants: a 5-year randomized controlled trial

Clinical outcomes of one-piece or segmented fixed prosthesis supported by six implants: a 5-year randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028968
Enrollment
Unknown
Registered
2020-01-10
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

complete edentulism

Interventions

experimental group:one-piece fixed prosthesis supported by six implants.
control group:segmented fixed prosthesis supported by six implants.

Sponsors

Shanghai 9th People's Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years and in good health; 2) The lower teeth can not be retained or there are no teeth in the upper jaw which need implant-supported fixed restoration; 3) Six implants could be placed without bone augmentation; 4) The distance from the posterior mandible nerver was >= 2mm; 5) Complete dentition (natural teeth or removable dentures) of the opposite jaw; 6) There was no systemic disease and contraindication of local implantation; 7) Enough inter-arch space for one-piece implant-supported fixed restoration 8) Volunteer to participate in the study and sign the informed consent, and can abide by the study plan.

Exclusion criteria

Exclusion criteria: 1) Uncontrolled diabetes or other systemic diseases; 2) Uncontrolled periodontal disease; 3) Severe smokers ( >= 10 / day); 4) not enough primary stability; 5) Implants or bone grafts were used in the proposed sites.

Design outcomes

Primary

MeasureTime frame
marginal bone loss;

Secondary

MeasureTime frame
implant survival;peri-implant soft tissue condition;mechanical complications;patient-reported outcomes;

Countries

China

Contacts

Public ContactHongchang Lai

Shanghai 9th People's Hospital affiliated to Shanghai Jiaotong University School of Medicine

hongchang_lai@126.com+86 13501881537

Outcome results

None listed

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