Laser-Lok Pilot Study

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliInatumika, sio kuajiri

Wadhamini

Christopher Barwacz

Washirika

BioHorizons, Inc.

JARIBIO LA KLINIKI: NCT03572244

BioSeek: nct03572244

Maneno muhimu

inflammation

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	02/29/2020
Iliyowasilishwa Kwanza:	06/18/2018
Uandikishaji uliokadiriwa Uliwasilishwa:	06/18/2018
Iliyotumwa Kwanza:	06/27/2018
Sasisho la Mwisho Liliwasilishwa:	03/22/2020
Sasisho la Mwisho Lilichapishwa:	03/24/2020
Tarehe halisi ya kuanza kwa masomo:	01/12/2016
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	02/05/2021
Tarehe ya Kukamilisha Utafiti:	02/05/2021

Hali au ugonjwa

Dental Implants

Uingiliaji / matibabu

Device: Laser-Lok

Device: Machine

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
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

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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

Matokeo

Hatua za Matokeo ya Msingi

1. Paper strip-based PICF sampling [8 weeks after implant placement]

Characterize pro-inflammatory and bone-metabolism mediator profiles adjacent to Laser-Lok microgrooved (LL) and machined (M) healing abutments as well as natural teeth after a period of healing (8 weeks) via paper strip-based PICF sampling.

Hatua za Matokeo ya Sekondari

1. Utilize Periotron 8000 to quantify PICF sample volume [8 weeks after implant placement]

Evaluate if functionally-oriented mucosa (analogous to natural teeth) around Laser-Lok microgrooved abutments reduce the volumetric production of PICF, as compared with standard machined abutments, relative to a natural tooth control.