Laser-Lok Pilot Study
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 02/29/2020 |
| Pirmasis pateikimas: | 06/18/2018 |
| Numatytas registravimas pateiktas: | 06/18/2018 |
| Pirmas paskelbtas: | 06/27/2018 |
| Paskutinis atnaujinimas pateiktas: | 03/22/2020 |
| Paskutinis atnaujinimas paskelbtas: | 03/24/2020 |
| Faktinė studijų pradžios data: | 01/12/2016 |
| Numatoma pirminio užbaigimo data: | 02/05/2021 |
| Numatoma studijų užbaigimo data: | 02/05/2021 |
Būklė ar liga
Intervencija / gydymas
Device: Laser-Lok
Device: Machine
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Laser-Lok A Laser-Lok microgrooved implant will be placed. | Device: Laser-Lok A microgrooved abutment will be placed |
| Active Comparator: Machine A machined implant will be placed. | Device: Machine A machined transmucosal healing abutment will be placed |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Paper strip-based PICF sampling [8 weeks after implant placement]
Antrinės rezultatų priemonės
1. Utilize Periotron 8000 to quantify PICF sample volume [8 weeks after implant placement]
