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RecruitingNCT02880891Updated Apr 26, 2022

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

An interventional study of prothetic procedure in Jaw, Edentulous, Partially, sponsored by Peking University. Recruiting at 1 site in China. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Peking University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Jaw, Edentulous, Partially
03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's planned enrollment of 20 is below the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    splinted

    splinted crown

    Procedure: prothetic procedure

  • No intervention
    non-splinted

    single crown

Interventions

  • Procedureprothetic procedure

    splinted crown

    Also known as: crown on the implants

06

What researchers measure

Primary outcomes

  1. Marginal Bone Levels (MBL)

    marginal bone level around the implants using CT scan

    Time frame: three years

  2. Probing Pocket Depth (PPD)

    Probing Pocket Depth (PPD) for the implants

    Time frame: three years

  3. Plaque (implant level)

    Plaque (implant level) of the crowns

    Time frame: three years

  4. Bleeding on Probing (Implant level)

    Bleeding on Probing of the crowns

    Time frame: three years

07

Study locations

1 of 1 sites recruiting
  • Department of Prosthodontics, Peking University School and Hospital of Stomatology
    Beijing, Beijing 100081, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02880891
Lead sponsor
Peking University
Collaborators
Dentsply Sirona Implants and Consumables
Responsible party
Jianzhang Liu (Associate Clinical Professor, Peking University) — Principal investigator
First posted
Aug 26, 2016
Start date
Sep 2016
Primary completion
Sep 2024 (estimated)
Completion
Sep 2026 (estimated)
Last update
Apr 26, 2022

Study contacts

Jianzhang Liu, Doctor
Contact
kqelite@163.com
+8613661174609
Jianzhang Liu, Doctor
principal investigator · Department of Prosthodontics School and Hospital of Stomatology of Peking University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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