Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tufts University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Soft tissue healing progress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of record at TUSDM who are over 18 years of age
- •Implants placed as immediate or delayed with a torque of ≥ 35 Ncm eligible to receive a healing abutment left exposed to heal;
- •Site of implant placement not requiring soft tissue augmentation at the time of healing abutment placement
- •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
- •Unable to give consent
- •active periodontal disease
- •Heavy smoker
- •Active infection at implant site
Arms & Interventions
Control: Pre Fabricated Healing Abutment
Subjects that are randomized into the control group will have a pre-fabricated healing abutment used.
Intervention: Healing Abutment- pre fabricated (Device)
Investigational: Customized Healing Abutment
Subjects that are randomized into the control group will have a customized healing abutment used.
Intervention: Healing Abutment- customized (Device)
Outcomes
Primary Outcomes
Soft tissue healing progress
Time Frame: 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 Outcomes
- Functional outcome of gingival appearance(3 months)
- Functional outcome of implant esthetic(3 months)