A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing
Primary Purpose
Jaw, Edentulous, Partially
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dental implant-abutments
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implants, Implant abutments
Eligibility Criteria
Inclusion Criteria:
- At least 19 years old
- Healthy enough to under go treatment
- Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
- Demonstrated willingness to undergo study treatment and to comply with study timeline -
Exclusion Criteria:
- Full edentulism
- Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing
Any indication of an inability to make autonomous decisions
-
Sites / Locations
- University of Alabama at Birmingham School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser-ablated dental implant-abutments
Smooth implant-abutments
Arm Description
Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Smooth dental implant-abutments will be attached to surgically placed dental implants.
Outcomes
Primary Outcome Measures
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level
Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.
Secondary Outcome Measures
Grams of Force Needed to Disrupt Tissue Attachment to the Abutment
A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Mean Change in Millimeters of Clinical Attachment to the Abutment
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Mean Change in Millimeters of Clinical Attachment to the Abutment
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Mean Change in Millimeters of Clinical Attachment to the Abutment
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Mean Change in Millimeters of Clinical Attachment to the Abutment
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Full Information
NCT ID
NCT01822223
First Posted
February 27, 2013
Last Updated
November 29, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
BioHorizons, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01822223
Brief Title
A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing
Official Title
A Controlled, Double-Blind, Randomized, Parallel-Arm, Clinical Trial to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments for Enhanced Oral Mucosal Healing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
BioHorizons, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine which implant-abutment design is more likely to promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant bone and soft-tissue health.
Detailed Description
The study will assess the integrity of the peri-implant oral soft-tissue attachment to implant abutments by comparing tissue responses to a laser-ablated implant-abutment and an implant-abutment manufactured with a smooth surface.
Investigators will assess the initial post-surgical peri-implant attachment-seal and will test whether or not the tissue-abutment interface re-forms with equal integrity when the abutment is removed and replaced with a new abutment.
Data will include histological, radiographic, clinical, and subjective aesthetics to compare the effectiveness of two abutment designs. Both devices are supplied by the BioHorizons Implant Systems Inc. of Birmingham, Alabama; the abutments are analogous in design and material except the test device has a laser-ablated surface and the control abutment is smooth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Dental Implants, Implant abutments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser-ablated dental implant-abutments
Arm Type
Experimental
Arm Description
Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Arm Title
Smooth implant-abutments
Arm Type
Active Comparator
Arm Description
Smooth dental implant-abutments will be attached to surgically placed dental implants.
Intervention Type
Device
Intervention Name(s)
Dental implant-abutments
Other Intervention Name(s)
BioHorizons' Laser-Lok® abutment, BioHorizons' smooth-surfaced abutment
Intervention Description
At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.
Primary Outcome Measure Information:
Title
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level
Description
Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.
Time Frame
8 weeks post-abutment placement
Secondary Outcome Measure Information:
Title
Grams of Force Needed to Disrupt Tissue Attachment to the Abutment
Description
A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Time Frame
8 weeks post-abutment placement
Title
Mean Change in Millimeters of Clinical Attachment to the Abutment
Description
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Time Frame
8 weeks post-abutment placement
Title
Mean Change in Millimeters of Clinical Attachment to the Abutment
Description
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Time Frame
12 weeks post-abutment placement
Title
Mean Change in Millimeters of Clinical Attachment to the Abutment
Description
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Time Frame
16 weeks post-abutment placement
Title
Mean Change in Millimeters of Clinical Attachment to the Abutment
Description
A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
Time Frame
12 month post-abutment placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 19 years old
Healthy enough to under go treatment
Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
Demonstrated willingness to undergo study treatment and to comply with study timeline -
Exclusion Criteria:
Full edentulism
Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing
Any indication of an inability to make autonomous decisions
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Reddy, DMD, DMSc
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31535464
Citation
Geurs NC, Geisinger ML, Vassilopoulos PJ, O'Neal SJ, Haigh SJ, Reddy MS. Optimizing Connective Tissue Integration on Laser-Ablated Implant Abutments. Clin Adv Periodontics. 2016 Aug;6(3):153-159. doi: 10.1902/cap.2016.150068.
Results Reference
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A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing
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