The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels
NCT ID: NCT04043286
Last Updated: 2024-12-04
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
19 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-30
Study Completion Date
2023-09-18
Brief Summary
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The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.
Detailed Description
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A total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. Each patient received 2 or 4 implants. A definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (T0) and left undisturbed throughout the duration of the study. On the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (T3), 6 months (T6), and 12 months (T12) after the implant placement. Throughout the study period (1 year), all implants remained unrestored. Marginal bone level changes (MBLC) were assessed using standardized periapical radiographs taken at T0 and T12. Peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.
Conditions
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Bone Loss
Implant Complication
Gingival Recession
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single center, prospective, randomized modified split mouth clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Control group
Split mouth: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the study
Group Type
NO_INTERVENTION
No interventions assigned to this group
Test group
Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Group Type
EXPERIMENTAL
Definitive abutment
Intervention Type
DEVICE
With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Interventions
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Definitive abutment
With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Intervention Type
DEVICE
Other Intervention Names
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On1 Base
On1 Concept
Eligibility Criteria
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Inclusion Criteria
* Minimum age 18
* Good oral hygiene
* Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars)
* Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site
* Have at least 8mm interocclusal restorative space
* Willing to participate and attend the planned follow-up visits.
* Good oral hygiene
* Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars)
* Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site
* Have at least 8mm interocclusal restorative space
* Willing to participate and attend the planned follow-up visits.
Exclusion Criteria
* History of alcohol/drug dependency, or any medical, physical, or psychological factor that might affect the surgical or prosthodontic procedures and follow-up examinations
* History of radiation therapy to the head and neck region
* History or current habit of smoking
* History or current habit of bruxism
* No opposing occluding dentition or prostheses
* Need for bone augmentation during implant placement
* Implant insertion torque value \<35 Ncm
* History of radiation therapy to the head and neck region
* History or current habit of smoking
* History or current habit of bruxism
* No opposing occluding dentition or prostheses
* Need for bone augmentation during implant placement
* Implant insertion torque value \<35 Ncm
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Nobel Biocare
INDUSTRY
Sponsor Role
collaborator
Loma Linda University
OTHER
Sponsor Role
lead
Responsible Party
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Joseph Kan, DDS
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Joseph Kan, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University School of Dentistry
Locations
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Loma Linda University, School of Dentistry
Loma Linda, California, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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5190024
Identifier Type: -
Identifier Source: org_study_id