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NCT Number: NCT07249242

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

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.

Recruiting

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Key information

Conditions

Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Lorenzo Mordini

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healing Abutment- customized

Device

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

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.

Primary outcomes

  1. 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

  1. Functional outcome of gingival appearance

    Time frame: 3 months

    gingival appearance- reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale.

  2. Functional outcome of implant esthetic

    Time frame: 3 months

    Implant esthetics - reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann-Marie Jacobson

CONTACT

[email protected]

Lorenzo Mordini

CONTACT

[email protected]

857-299-4168

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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