Health TrialsbyHealthPanel

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

ConditionImplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTufts University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Unable to give consent

active periodontal disease

Heavy smoker

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Control: Pre Fabricated Healing AbutmentActive comparator 1 intervention
Group B: Investigational: Customized Healing AbutmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

Functional outcome of gingival appearance

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.

Time frame
3 months
2

Functional outcome of implant esthetic

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Source ClinicalTrials.gov
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