Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT02880891

Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants

Led by Peking University · Updated on 2022-04-26

20

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

P

Peking University

Lead Sponsor

D

Dentsply Sirona Implants and Consumables

Collaborating Sponsor

AI-Summary

What this Trial Is About

The microthreaded and platform switched implants could control the stress in the suitable range. The splint would disturb the function. So it is necessary to know whether the splinted single-unit crowns is fit for the adjacent multi-implants. Outcome variables: Splinted single-unit crowns on one side implants and non-splinted single-unit crowns on the other side Materials and method: 80-100 consecutive implants in at least 20 patients would be included for implant- supported restorations in the posterior maxilla or mandibular. All patients would be in general good health. For every patient, the same posterior teeth had lost on both sides for more than 6 months. All patients were treated by the same qualified surgeon. Prosthetics procedure would be performed by an experienced prosthodontist. The two sides were allocated to the test or the control group according to the predefined computer-generated randomization table. Clinical evaluations and radiographic analysis were performed by an oral and maxillofacial radiologist who was not aware of the type of Prosthetics technique that was used.

CONDITIONS

Official Title

Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be in general good health.
  • Need fixed implant-supported prosthesis on both sides of the posterior upper or lower jaw, with at least two adjacent missing teeth from the first premolar to the second molar.
  • Patients must be able to be followed for 36 months after prosthetic loading.
  • Must have a wide enough bone ridge to allow placement of a 4mm platform implant with at least 8mm bone height.
  • Same posterior teeth must have been missing on both sides for more than 6 months.
Not Eligible

You will not qualify if you...

  • Bone ridge not sufficient to place a 4mm platform implant with at least 8mm vertical bone height.
  • Need for pre-surgical bone or soft tissue augmentation in the planned implant area.
  • Uncontrolled pathological conditions in the mouth.
  • History of radiation therapy in the head and neck area.
  • History of chemotherapy within 5 years before surgery.
  • Any systemic or local disease that could affect healing or implant integration.
  • Uncontrolled diabetes mellitus.
  • Use of corticosteroids or other drugs affecting healing or implant integration.
  • Smoking more than 10 cigarettes per day.
  • Current alcohol or drug abuse.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Prosthodontics, Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China, 100081

Actively Recruiting

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Research Team

J

Jianzhang Liu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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