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

NCT ID: NCT07249242

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-22

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control: Pre Fabricated Healing Abutment

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

Group Type ACTIVE_COMPARATOR

Healing Abutment- pre fabricated

Intervention Type DEVICE

A pre-fabricated (pre- made) healing abutment will be used on subjects in this study as part of their implant healing process.

Investigational: Customized Healing Abutment

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

Group Type EXPERIMENTAL

Healing Abutment- customized

Intervention Type DEVICE

A customized healing abutment will be used on subjects in this study as part of their implant healing process.

Interventions

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Healing Abutment- customized

A customized healing abutment will be used on subjects in this study as part of their implant healing process.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorenzo Mordini

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

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Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lorenzo Mordini

Role: CONTACT

857-299-4168

Ann-Marie Jacobson

Role: CONTACT

Facility Contacts

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Lorenzo Mordini

Role: primary

Other Identifiers

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STUDY00006389

Identifier Type: -

Identifier Source: org_study_id

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