Dental Implants
Conditions
Keywords
Laser-Lok, Crevicular fluid, Machined, Abutment
Brief summary
A pilot, prospective, randomized clinical trial is proposed. It is primarily aimed at assessing the expression of pro-inflammatory cytokine and bone metabolism mediators adjacent to Laser-Lok microgrooved (LL) or machined (M) transmucosal healing abutments. The pilot study would seek recruitment of 12 subjects requiring replacement of a single, toothbound molar or premolar in the maxilla or mandible with an implant-supported restoration.
Detailed description
The purpose of this research study is to compare two different implant abutment designs, microgrooved and machined. The implant abutment is the dental prosthetic part that connects the implant to the crown. As a part of this study, subjects will have a dental implant surgically placed in their jaw bone. The implant will serve as the artificial root. After the implant heals, subjects will have the abutment and crown placed on the implant. This study will compare levels of inflammation next to the implant abutment. Both implant abutment designs are FDA approved but differ in microtexturing. This study will determine if these texture differences have any impact on the healing of subjects' jaw bone and gums after implant surgery.
Interventions
DEVICELaser-Lok
A microgrooved abutment will be placed
DEVICEMachined
A machined transmucosal healing abutment will be placed
Sponsors
BioHorizons, Inc.
Christopher Barwacz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
6 subjects will be randomized to Laser-Lok placement, and 6 subjects will be randomized to machined healing abutment placement. The assignment will be a 1:1 scheme, with the study coordinator randomly opening pre-assigned envelopes to determine implant.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or greater * Subjects requiring the replacement of either a tooth-bound molar or premolar in either arch that do not require simultaneous implant site development (i.e., bone and/or soft-tissue grafting) * Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal attachment loss up to 2.0mm * An opposing dentition with teeth, implants, or fixed prosthesis * Subjects must be willing to forgo use of a provisional appliance (e.g., removable interim partial denture (or) flipper, essix appliance, etc.) during the active portion (from implant placement to 8 week +IP visit) of the study protocol. * Subjects must be willing to follow instructions related to the study procedures * Subjects must have read, understood, and signed the informed consent document
Exclusion criteria
* Insufficient interocclusal space for implant placement and/or restoration at study site * Insufficient lateral ridge volume for implant placement in a prosthetically-driven location * More than 2.0 mm of vertical bone loss at study site as measured from the interproximal crestal bone on the adjacent teeth * Untreated rampant caries * Tobacco use free for ≤ 6 months * Liver or kidney dysfunction/failure * Active severe infectious diseases that may affect normal healing and/or bone metabolism * Uncontrolled diabetes determined as HbA1c value \> 7% * Current alcohol or drug abuse * Need for systemic medications (e.g., corticosteroids) that may influence postoperative healing and/or osseointegration * History of relevant head/neck cancer and/or radiation of the head/neck within the last 24 months * Subjects who currently use IV bisphosphonates or have a history of IV bisphosphonate use * Subjects with metabolic bone diseases such as severe osteoporosis or Paget's disease of bone * Known pregnancy or nursing mothers * Unwilling to forgo use of a provisional appliance (e.g., removable interim partial denture (or) flipper, essix appliance, etc.) during the active portion (from implant placement to 8 week +IP visit) of the study protocol. * Unable or unwilling to return for follow-up visits for a period of 1 year * Unlikely to be able to comply with study procedures according to investigators judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | 8 weeks after implant placement | Determine if there is a difference in peri-implant crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for peri-implant crevicular fluid that is next to Laser-Lok microgrooved (LL) and machined (M) healing abutments after a healing period of 8 weeks after implant placement. |
| Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | 8 weeks after implant placement | Determine if there is a difference in gingival crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for gingival crevicular fluid that is next to Laser-Lok microgrooved abutments (LL) and machined (M) habutments after a healing period of 8 weeks after implant placement. |
Participant flow
Pre-assignment details
Of the 23 enrolled participants, 12 met the inclusion criteria, were randomized to treatment, and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Laser-Lok A Laser-Lok microgrooved implant will be placed.
Laser-Lok: A microgrooved abutment will be placed | 6 |
| Machine A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Machine | Total | Laser-Lok |
|---|---|---|---|
| Age, Continuous | 61 years | 62 years | 62 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
Determine if there is a difference in gingival crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for gingival crevicular fluid that is next to Laser-Lok microgrooved abutments (LL) and machined (M) habutments after a healing period of 8 weeks after implant placement.
Time frame: 8 weeks after implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL8 | 6.30 log pg/ml | Standard Deviation 0.84 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP13 | 5.63 log pg/ml | Standard Deviation 0.36 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIP10 | 1.13 log pg/ml | Standard Deviation 0.84 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logENA78 | 3.94 log pg/ml | Standard Deviation 0.79 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL6 | 1.86 log pg/ml | Standard Deviation 0.09 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMIG | 6.88 log pg/ml | Standard Deviation 0.18 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP8b | 11.10 log pg/ml | Standard Deviation 0.5 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteopontin | 6.82 log pg/ml | Standard Deviation 0.49 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP1 | 4.12 log pg/ml | Standard Deviation 0.35 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logITAC1 | 2.48 log pg/ml | Standard Deviation 0.2 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL_1B | 4.70 log pg/ml | Standard Deviation 0.82 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteoprotegerin | 2.84 log pg/ml | Standard Deviation 1.56 |
| Laser-Lok | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logTNFa | 2.52 log pg/ml | Standard Deviation 0.5 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteoprotegerin | 3.69 log pg/ml | Standard Deviation 0.82 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logTNFa | 2.13 log pg/ml | Standard Deviation 1.15 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL6 | 2.39 log pg/ml | Standard Deviation 1.06 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL8 | 6.29 log pg/ml | Standard Deviation 1.31 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP1 | 4.47 log pg/ml | Standard Deviation 0.62 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIP10 | 2.05 log pg/ml | Standard Deviation 2.14 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP8b | 11.17 log pg/ml | Standard Deviation 0.76 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL_1B | 5.06 log pg/ml | Standard Deviation 0.8 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP13 | 5.18 log pg/ml | Standard Deviation 1.87 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logENA78 | 3.75 log pg/ml | Standard Deviation 0.68 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMIG | 6.95 log pg/ml | Standard Deviation 0.32 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteopontin | 6.56 log pg/ml | Standard Deviation 1.21 |
| Machine | Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logITAC1 | 2.18 log pg/ml | Standard Deviation 1.01 |
Primary
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
Determine if there is a difference in peri-implant crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for peri-implant crevicular fluid that is next to Laser-Lok microgrooved (LL) and machined (M) healing abutments after a healing period of 8 weeks after implant placement.
Time frame: 8 weeks after implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL8 | 6.54 log pg/ml | Standard Deviation 0.6 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP13 | 5.73 log pg/ml | Standard Deviation 0.94 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIP10 | 1.29 log pg/ml | Standard Deviation 0.79 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logENA78 | 4.05 log pg/ml | Standard Deviation 0.53 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL6 | 1.80 log pg/ml | Standard Deviation 0.31 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMIG | 6.95 log pg/ml | Standard Deviation 0.12 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP8b | 11.37 log pg/ml | Standard Deviation 0.37 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteopontin | 6.44 log pg/ml | Standard Deviation 1.19 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP1 | 4.48 log pg/ml | Standard Deviation 0.64 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logITAC1 | 2.53 log pg/ml | Standard Deviation 0.36 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL_1B | 5.19 log pg/ml | Standard Deviation 0.61 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteoprotegerin | 2.94 log pg/ml | Standard Deviation 0.95 |
| Laser-Lok | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logTNFa | 2.25 log pg/ml | Standard Deviation 1.18 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteoprotegerin | 3.38 log pg/ml | Standard Deviation 1.06 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logTNFa | 2.15 log pg/ml | Standard Deviation 1 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL6 | 1.61 log pg/ml | Standard Deviation 0.36 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL8 | 5.52 log pg/ml | Standard Deviation 1.06 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP1 | 3.89 log pg/ml | Standard Deviation 0.72 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIP10 | 1.32 log pg/ml | Standard Deviation 1.09 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP8b | 10.61 log pg/ml | Standard Deviation 1.11 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logIL_1B | 4.92 log pg/ml | Standard Deviation 1.08 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMMP13 | 5.78 log pg/ml | Standard Deviation 1.08 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logENA78 | 3.27 log pg/ml | Standard Deviation 0.65 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logMIG | 6.63 log pg/ml | Standard Deviation 0.51 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logOsteopontin | 6.50 log pg/ml | Standard Deviation 0.96 |
| Machine | Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement | logITAC1 | 2.56 log pg/ml | Standard Deviation 0.84 |