Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healing Abutment- customized, Healing Abutment- pre fabricated.
- Who it may be relevant to
- Registry conditions: Implant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
Overview
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
- Device Healing Abutment- customized
A customized healing abutment will be used on subjects in this study as part of their implant healing process. - Device Healing 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.
Primary outcome measures
- Soft tissue healing progress [Time frame: 3 months]
Secondary outcome measures (2)
- Functional outcome of gingival appearance [Time frame: 3 months]
- Functional outcome of implant esthetic [Time frame: 3 months]
Eligibility criteria
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
- Pregnant
- Active infection at implant site
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tufts University School of Dental Medicine — Boston
Identifiers
NCT: NCT07249242 · STUDY00006389