Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments

Tufts University

Status: Enrolling

Conditions: Implant

Treatments: Device: Healing Abutment- pre fabricated; Device: Healing Abutment- customized

Study type: Interventional

Funder types: Other

Identifiers

NCT07249242

STUDY00006389

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Control: Pre Fabricated Healing Abutment

Active Comparator group

Description:

Subjects that are randomized into the control group will have a pre-fabricated healing abutment used.

Treatment:

Device: Healing Abutment- pre fabricated

Investigational: Customized Healing Abutment

Experimental group

Description:

Subjects that are randomized into the control group will have a customized healing abutment used.

Treatment:

Device: Healing Abutment- customized