N/A
N=12
Comparing Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments
Dental Implants
Bottom Line
View on ClinicalTrials.gov: NCT03572244 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: 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 — 2.25; 2.15; 1.80; 1.61 log pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser-Lok (Device); Machined (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Barwacz
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
2.25; 2.15; 1.80; 1.61; 6.54; 5.52 | — |
| 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 |
2.52; 2.13; 1.86; 2.39; 6.30; 6.29 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03572244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.