Jaw, Edentulous, Partially
Conditions
Keywords
Dental Implants, Implant abutments
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.
Interventions
DEVICEDental implant-abutments
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.
Sponsors
BioHorizons, Inc.
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At least 19 years old 2. Healthy enough to under go treatment 3. Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue 4. Demonstrated willingness to undergo study treatment and to comply with study timeline -
Exclusion criteria
1. Full edentulism 2. Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing 3. Any indication of an inability to make autonomous decisions \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number od Participants With Consistent Connective Tissue Integration at a Histologic Level | 8 weeks post-abutment placement | Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grams of Force Needed to Disrupt Tissue Attachment to the Abutment | 8 weeks post-abutment placement | 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 | 8 weeks post-abutment placement | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser-ablated Dental Implant-abutments Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Dental implant-abutments: 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. | 10 |
| Smooth Implant-abutments Smooth dental implant-abutments will be attached to surgically placed dental implants.
Dental implant-abutments: 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. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Laser-ablated Dental Implant-abutments | Smooth Implant-abutments | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Gender Female | 7 Participants | 8 Participants | 15 Participants |
| Gender Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 8 weeks post-abutment placement
Population: The number of participants entered represents measured data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser-ablated Dental Implant-abutments | Number od Participants With Consistent Connective Tissue Integration at a Histologic Level | 10 participants |
| Smooth Implant-abutments | Number od Participants With Consistent Connective Tissue Integration at a Histologic Level | 10 participants |
Secondary
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.
Time frame: 8 weeks post-abutment placement
Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.
Secondary
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.
Time frame: 8 weeks post-abutment placement
Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.
Secondary
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.
Time frame: 12 weeks post-abutment placement
Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.
Secondary
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.
Time frame: 16 weeks post-abutment placement
Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.
Secondary
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.
Time frame: 12 month post-abutment placement
Population: No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.