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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02880891
Recruitment Status : Not yet recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Dentsply Sirona Implants
Information provided by (Responsible Party):
Jianzhang Liu, Peking University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Procedure: prothetic procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: School and Hospital of Somatology, Peking University
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: splinted
splinted crown
Procedure: prothetic procedure
splinted crown
Other Name: crown on the implants

No Intervention: non-splinted
single crown

Primary Outcome Measures :
  1. Marginal Bone Levels (MBL) [ Time Frame: three years ]
    marginal bone level around the implants using CT scan

  2. Probing Pocket Depth (PPD) [ Time Frame: three years ]
    Probing Pocket Depth (PPD) for the implants

  3. Plaque (implant level) [ Time Frame: three years ]
    Plaque (implant level) of the crowns

  4. Bleeding on Probing (Implant level) [ Time Frame: three years ]
    Bleeding on Probing of the crowns

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Jianzhang Liu, Associate Clinical Professor, Peking University Identifier: NCT02880891     History of Changes
Other Study ID Numbers: PKUSSIRB-201520029
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases