ImplantNCT07249242
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
A study testing Healing Abutment- customized and Healing Abutment- pre fabricated in people with Implant, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant
- What is being tested?
- Healing Abutment- customized and Healing Abutment- pre fabricated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Unable to give consent
- active periodontal disease
- Heavy smoker
- Pregnant
- Active infection at implant site
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
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
- Being tested
- Healing Abutment- customized, Healing Abutment- pre fabricated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Abutment- customizedDevice
A customized healing abutment will be used on subjects in this study as part of their implant healing process.
Healing Abutment- pre fabricatedDevice
A pre-fabricated (pre- made) healing abutment will be used on subjects in this study as part of their implant healing process.
| Study group | Role | What they receive |
|---|---|---|
| Control: Pre Fabricated Healing Abutment | Active comparator | Subjects that are randomized into the control group will have a pre-fabricated healing abutment used. Receives: 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. Receives: Device: Healing Abutment- customized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start22 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Mordini, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249242
- Sponsor's protocol ID
- STUDY00006389
- Status last verified
- Nov 2026
- First submitted
- 22 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
- ClinicalTrials.gov ID
- NCT07249242
- Acronym / sponsor ID
- STUDY00006389
- Conditions
- Implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Pre Fabricated Healing Abutment | Active comparator | Device: Healing Abutment- pre fabricatedSubjects that are randomized into the control group will have a pre-fabricated healing abutment used. |
| Investigational: Customized Healing Abutment | Experimental | Device: Healing Abutment- customizedSubjects that are randomized into the control group will have a customized healing abutment used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Unable to give consent
- active periodontal disease
- Heavy smoker
- Pregnant
- Active infection at implant site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Abutment- customizedA customized healing abutment will be used on subjects in this study as part of their implant healing process. | Device | Investigational: Customized Healing Abutment |
| Healing Abutment- pre fabricatedA pre-fabricated (pre- made) healing abutment will be used on subjects in this study as part of their implant healing process. | Device | Control: Pre Fabricated Healing Abutment |
Primary outcome
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.
2 secondary outcomes
Functional outcome of gingival appearance
Time frame: 3 months
Functional outcome of implant esthetic
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Mordini principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Abutment- customized and Healing Abutment- pre fabricated in people with Implant, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue healing progress (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.