Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants
Primary Purpose
Jaw, Edentulous, Partially
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prothetic procedure
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
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
Sites / Locations
- Department of Prosthodontics, Peking University School and Hospital of StomatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
splinted
non-splinted
Arm Description
splinted crown
single crown
Outcomes
Primary Outcome Measures
Marginal Bone Levels (MBL)
marginal bone level around the implants using CT scan
Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) for the implants
Plaque (implant level)
Plaque (implant level) of the crowns
Bleeding on Probing (Implant level)
Bleeding on Probing of the crowns
Secondary Outcome Measures
Full Information
NCT ID
NCT02880891
First Posted
August 18, 2016
Last Updated
April 19, 2022
Sponsor
Peking University
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT02880891
Brief Title
Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants
Official Title
School and Hospital of Somatology, Peking University
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
splinted
Arm Type
Experimental
Arm Description
splinted crown
Arm Title
non-splinted
Arm Type
No Intervention
Arm Description
single crown
Intervention Type
Procedure
Intervention Name(s)
prothetic procedure
Other Intervention Name(s)
crown on the implants
Intervention Description
splinted crown
Primary Outcome Measure Information:
Title
Marginal Bone Levels (MBL)
Description
marginal bone level around the implants using CT scan
Time Frame
three years
Title
Probing Pocket Depth (PPD)
Description
Probing Pocket Depth (PPD) for the implants
Time Frame
three years
Title
Plaque (implant level)
Description
Plaque (implant level) of the crowns
Time Frame
three years
Title
Bleeding on Probing (Implant level)
Description
Bleeding on Probing of the crowns
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianzhang Liu, Doctor
Phone
+8613661174609
Email
kqelite@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhang Liu, Doctor
Organizational Affiliation
Department of Prosthodontics School and Hospital of Stomatology of Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Prosthodontics, Peking University School and Hospital of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yongsheng zhou, PHD
Email
kqelite@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants
We'll reach out to this number within 24 hrs