Gum healing around implants with prefabricated versus customized healing abutments
Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
This will test whether customized healing abutments or prefabricated ones lead to better gum healing in adults receiving dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07249242 on ClinicalTrials.gov |
What this trial studies
Adults who are patients at Tufts University School of Dental Medicine and receiving implants that meet the study criteria will receive either a prefabricated or a customized healing abutment as part of their usual implant care. The research team will collect clinical healing data and compare peri-implant soft tissue outcomes between the two abutment types. Much of the care is standard clinical treatment, and researchers will use those clinical visits and measurements for the comparison. The goal is to determine whether one abutment approach produces more favorable soft tissue form and healing after implant placement.
Who should consider this trial
Good fit: Adults (>18) who are patients of record at Tufts University School of Dental Medicine with an implant placed (immediate or delayed) achieving ≥35 Ncm torque, no active periodontal disease or infection at the site, no need for soft tissue augmentation at abutment placement, and sufficient tooth and occlusal space for restoration.
Not a fit: Patients with active periodontal disease, active infection at the implant site, heavy smokers, pregnant individuals, those unable to consent, or implants that require soft tissue augmentation or that did not achieve the required torque are unlikely to qualify or benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could lead to improved gum contour and healing around implants, which may improve long-term aesthetics and comfort.
How similar studies have performed: Prior dental research has suggested customized healing abutments can improve soft tissue contour and esthetics in some cases, but findings are limited and not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Lorenzo Mordini — Tufts University
- Study coordinator: Lorenzo Mordini
- Email: Lorenzo.Mordini@tufts.edu
- Phone: 857-299-4168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.