Platform Switched Implant and Bone Level Alteration
Primary Purpose
Edentulous, Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subcrestal implant placement
Paracrestal implant placement
prophylactic antibiotics
dental implant
x-ray examination
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous focused on measuring platform switching, crestal bone remodeling, soft tissue thickness, dental implant
Eligibility Criteria
Inclusion Criteria:
- lose of two posterior teeth more than 3 months
- generally healthy (ASA score I)
- non-smoking
- periodontally healthy
- sufficient bone volume to place an implant without augmentation procedure
Exclusion Criteria:
- medical and/or psychiatric contraindication to dental implant restoration
- local infection
- pregnancy or lactating
- poor oral hygiene
- tissue deficiency
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Subcrestal
Paracrestal
Arm Description
implants that are placed below the alveolar ridge
implants that are placed flush to the alveolar ridge
Outcomes
Primary Outcome Measures
Changes of marginal bone levels of dental implant
Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.
Secondary Outcome Measures
Bleeding on probing(BOP)
bleeding index whiling probing the implant restorations
Probing pocket depth(PPD)
probing depth of implant supported restorations
modified plaque index(PI)
Modified plaque index to evaluate the oral hygiene conditions
Full Information
NCT ID
NCT02867982
First Posted
July 24, 2016
Last Updated
August 13, 2016
Sponsor
Beijing University Health Science Center
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT02867982
Brief Title
Platform Switched Implant and Bone Level Alteration
Official Title
Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University Health Science Center
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a two-year prospective randomized clinical study to to evaluate whether the gingival thickness and insertion depth of dental implants have any influence on marginal bone levels changes around platform switched implants.
Detailed Description
Patient selection: Patients at the Department of Oral Implantology, Peking University School and Hospital of stomatology, Bei Jing, China, who seek for implant restoration for two continous posterior teeth are potentially recruited. Inclusion criteria are generally healthy (ASA score I), non-smoking, periodontally healthy, and sufficient bone volume to place an implant without augmentation procedure. Patients were excluded in cases of medical and/or psychiatric contraindications, local infection, pregnancy or lactating, poor oral hygiene, tissue deficiency, or not willing to participate in this study.
Randomization: The two implant sites of each subject are randomly assigned to two different group with a predefined randomization tables. In order to reduce the chance of unfavorable splits between groups in terms of key prognostic factors,the randomization process will take into account the following variables: patient's gender, age, presence of adjacent teeth, distal extension sites and site location in the dental arch. Assignment will perform using a sealed envelope.
Surgical protocol: Before the surgical procedure, prophylactic antibiotics of 1g amoxicillin will prescribed to the patient 1 h before surgery, and continued with 2 g/day for 6 days. After crestal incision, full thickness buccal flap was raised, whereas lingual part was not elevated. Thickness of soft tissues was measured with 1.0-mm marked periodontal probe on the top of bone crest in the center of the two future implant sites. This ensured direct visibility of mucosal thickness during measurement. After measurements, full-thickness lingual flap is raised and subsequent implant osteotomy is finished, Two dental implants (Dentsply Implants Manufacturing GmbH, Mannheim, Germany) with diameter of 3.5 mm are ready to torch into the bone cavities. In one site (group 1), the platform of implants are placed at the crestal level (flush to the alveolar ridge) . In the other site (group 2), the implants are placed 1mm below the alveolar ridge. narrow healing abutment are connected to all the implants. The flap are repositioned and closed with interrupted single sutures. Implants are allowed for a un-submerged healing. 3 month after healing, the implant level impressions are taken, splinted restorations of two neighbouring posterior teeth are delivered 2 weeks later.
Radiographic and Clinical Examination: All the patients are required for recall visit at 3, 6,12 months and 2 years post surgery. A digital peri-apical radiograph was taken at the 1 year and 2year follow-up examination for bone level evaluation using a film holder to aim the x-ray beam perpendicular to the implant threads, and the implant length is used as calibration for the measurement. Using a image analysis software (ImageJ, version 1.47, NIH, Bethesda, MD, USA), the investigators are able to have an accurate assessment of the crest of bone and to analyze the bone changes over period of time. Bone loss was defined as a positive value and bone gain as a negative one. Mean values, standard deviations, and maximum and minimum values were calculated. Furthermore, periodontal parameters [bleeding on probing (BOP), probing pocket depth (PPD), modified plaque index on adjacent teeth and implants] were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous, Bone Resorption
Keywords
platform switching, crestal bone remodeling, soft tissue thickness, dental implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subcrestal
Arm Type
Other
Arm Description
implants that are placed below the alveolar ridge
Arm Title
Paracrestal
Arm Type
Other
Arm Description
implants that are placed flush to the alveolar ridge
Intervention Type
Procedure
Intervention Name(s)
Subcrestal implant placement
Intervention Description
Dental implants placed 2 mm below the alveolar ridge
Intervention Type
Procedure
Intervention Name(s)
Paracrestal implant placement
Intervention Description
Dental implants placed flush to the alveolar ridge
Intervention Type
Drug
Intervention Name(s)
prophylactic antibiotics
Intervention Description
amoxicillin was used before and after implant surgery for prophylactic reasons
Intervention Type
Device
Intervention Name(s)
dental implant
Intervention Description
dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge
Intervention Type
Radiation
Intervention Name(s)
x-ray examination
Intervention Description
radiographies were taken before treatment and at different time point during the follow-up period
Primary Outcome Measure Information:
Title
Changes of marginal bone levels of dental implant
Description
Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.
Time Frame
3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Secondary Outcome Measure Information:
Title
Bleeding on probing(BOP)
Description
bleeding index whiling probing the implant restorations
Time Frame
3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Title
Probing pocket depth(PPD)
Description
probing depth of implant supported restorations
Time Frame
3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Title
modified plaque index(PI)
Description
Modified plaque index to evaluate the oral hygiene conditions
Time Frame
3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
lose of two posterior teeth more than 3 months
generally healthy (ASA score I)
non-smoking
periodontally healthy
sufficient bone volume to place an implant without augmentation procedure
Exclusion Criteria:
medical and/or psychiatric contraindication to dental implant restoration
local infection
pregnancy or lactating
poor oral hygiene
tissue deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Jiang, DMD
Organizational Affiliation
Peking University school and hospital of stomotology, Department of oral implantology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Platform Switched Implant and Bone Level Alteration
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