N/A
N=61
Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
Dental Implant, Single-Tooth · Esthetics, Dental
Bottom Line
View on ClinicalTrials.gov: NCT01871220 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites — 9.860; 9.770; 9.684; 9.618 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Concave Transition Profile (Device); Divergent Transition Profile (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Barwacz
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites |
9.860; 9.770; 9.684; 9.618; 9.674; 9.610 | — |
| SECONDARY Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery |
2.722; 2.814; 2.667; 2.597; 2.840; 2.468 | — |
| SECONDARY Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. |
2.704; 3.307; 3.407; 3.936; 3.620; 4.177 | — |
Summary
The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or greater
- Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
- Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
- An opposing dentition with teeth, implants, or fixed prosthesis
- 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
Exclusion Criteria
- Insufficient interocclusal space for implant placement and/or restoration at study site
- More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
- Untreated rampant caries
- Tobacco use free for ≤ 6 months
- Liver or kidney disfunction/failure
- Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
- Uncontrolled diabetes
- Current alcohol or drug abuse
- Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- History of relevant head/neck cancer and/or radiation of the head/neck
- Subjects who currently use bisphosphonates or have a history of bisphosphonate use
- Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
- Known pregnancy or nursing mothers
- 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 (NCT01871220). 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.