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Recruiting NCT02880891

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

No phase Interventional Jaw, Edentulous, Partially

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prothetic procedure.
Who it may be relevant to
Registry conditions: Jaw, Edentulous, Partially. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

School and Hospital of Somatology, Peking University

Overview

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.

Detailed description

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.

Interventions

  • Procedure prothetic procedure
    splinted crown

Primary outcome measures

  • Marginal Bone Levels (MBL) [Time frame: three years]
  • Probing Pocket Depth (PPD) [Time frame: three years]
  • Plaque (implant level) [Time frame: three years]
  • Bleeding on Probing (Implant level) [Time frame: three years]

Eligibility criteria

Inclusion criteria

  • All patients would be in general good health.
  • All patients would need for fixed implant-supported prosthesis in the double posterior maxillae or mandibulae (there were at least two corresponding adjacent teeth lost in both sides from the 1st premolar to 2nd molar).
  • The patients could be followed-up for 36 months after prosthetic loading
  • A wide ridge of bone allowing the insertion of a 4mm platform implant and at least 8mm of bone in vertical height would be required.
  • The same posterior teeth had lost on both sides for more than 6 months.

Exclusion criteria

  • For implant site, a ridge of bone do not allow the insertion of a 4mm platform implant and at least 8mm of bone in vertical height.
  • Current need for pre-surgical bone or soft tissue augmentation in the planned implant area;
  • Uncontrolled pathologic processes in the oral cavity;
  • History of radiation therapy in the head and neck region;
  • History of chemotherapy within 5 years prior to surgery;
  • Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration;
  • Uncontrolled diabetes mellitus;
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration;
  • Smoking more than 10 cigarettes/day;
  • Present alcohol and/or drug abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Prosthodontics, Peking University School and Hospital of Stomatology — Beijing

Identifiers

NCT: NCT02880891 · PKUSSIRB-201520029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗