Implant
Conditions
Brief summary
The purpose of this study is to compare how well our research participants heal with two different kind of healing abutments used. One is pre-fabricated, meaning it is made to fit anyone, and the other is customized to fit the subject specifically. Much of what will occur is 'standard of care' meaning it is part of a subject's typical dental treatment and the research team wants to just look at the data for this research study, as well.
Interventions
DEVICEHealing Abutment- customized
A customized healing abutment will be used on subjects in this study as part of their implant healing process.
DEVICEHealing Abutment- pre fabricated
A pre-fabricated (pre- made) healing abutment will be used on subjects in this study as part of their implant healing process.
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of record at TUSDM who are over 18 years of age 2. Implants placed as immediate or delayed with a torque of ≥ 35 Ncm eligible to receive a healing abutment left exposed to heal; 3. Site of implant placement not requiring soft tissue augmentation at the time of healing abutment placement 4. Sufficient mesial, distal space (7mm for anterior teeth and premolar and 8-9mm for molars) and interocclusal space (7-8mm for screw and cement retained crowns) for definitive restorations (12).
Exclusion criteria
1. Unable to give consent 2. active periodontal disease 3. Heavy smoker 4. Pregnant 5. Active infection at implant site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue healing progress | 3 months | Clinical Evaluation of Soft Tissue Healing; the clinician will perform intraoral examination on tissue color, contour, signs of inflammation, presence of keratinized tissue and soft tissue integration around the healing abutment. These are all visual observations and will be recorded as Yes/No. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome of gingival appearance | 3 months | gingival appearance- reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale. |
| Functional outcome of implant esthetic | 3 months | Implant esthetics - reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale. |
Countries
United States
Contacts
CONTACTLorenzo Mordini
CONTACTAnn-Marie Jacobson
PRINCIPAL_INVESTIGATORLorenzo Mordini
Tufts University
Outcome results
None listed