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

NCT07249242 | Recruiting FDA Device

• 1 other identifier: STUDY00006389
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant

Outcome Measures

Primary Outcomes (1)

• Soft tissue healing progress

  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.

  3 months

Secondary Outcomes (2)

• Functional outcome of gingival appearance

  3 months

• Functional outcome of implant esthetic

  3 months

Study Arms (2)

Control: Pre Fabricated Healing Abutment

ACTIVE COMPARATOR

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

Device: Healing Abutment- pre fabricated

Investigational: Customized Healing Abutment

EXPERIMENTAL

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

Device: Healing Abutment- customized

Interventions

Healing Abutment- customized DEVICE

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

Investigational: Customized Healing Abutment

Healing Abutment- pre fabricated DEVICE

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

Control: Pre Fabricated Healing Abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Unable to give consent
• active periodontal disease
• Heavy smoker
• Pregnant
• Active infection at implant site

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

Study Officials

• Lorenzo Mordini

  Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Mordini

CONTACT

857-299-4168; Lorenzo.Mordini@tufts.edu

Ann-Marie Jacobson

CONTACT

dentalresearchadministration@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 25, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)