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

April 19, 2022 updated by: Jianzhang Liu, Peking University

School and Hospital of Somatology, Peking University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jianzhang Liu, Doctor
  • Phone Number: +8613661174609
  • Email: kqelite@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Recruiting
        • Department of Prosthodontics, Peking University School and Hospital of Stomatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients would be in general good health.
  2. 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).
  3. The patients could be followed-up for 36 months after prosthetic loading
  4. 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.
  5. The same posterior teeth had lost on both sides for more than 6 months.

Exclusion Criteria:

  1. 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.
  2. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area;
  3. Uncontrolled pathologic processes in the oral cavity;
  4. History of radiation therapy in the head and neck region;
  5. History of chemotherapy within 5 years prior to surgery;
  6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration;
  7. Uncontrolled diabetes mellitus;
  8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration;
  9. Smoking more than 10 cigarettes/day;
  10. Present alcohol and/or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: splinted
splinted crown
Procedure: prothetic procedure
splinted crown
Other Names:
  • crown on the implants
No Intervention: non-splinted
single crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone Levels (MBL)
Time Frame: three years
marginal bone level around the implants using CT scan
three years
Probing Pocket Depth (PPD)
Time Frame: three years
Probing Pocket Depth (PPD) for the implants
three years
Plaque (implant level)
Time Frame: three years
Plaque (implant level) of the crowns
three years
Bleeding on Probing (Implant level)
Time Frame: three years
Bleeding on Probing of the crowns
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Dentsply Sirona Implants

Investigators

  • Principal Investigator: Jianzhang Liu, Doctor, Department of Prosthodontics School and Hospital of Stomatology of Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUSSIRB-201520029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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