Tooth LossNCT06783595
Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone
An observational study of Tooth Loss and Implant Site Reaction, run by Loma Linda University at 1 site in United States.
Trial summary
The study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Implant Site Reaction
- What is being tested?
- intraoral scan
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to Dec 2026
- Phase
- Observational
- 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
Study population: Patients selected for the participation in the study will be solely from the Center of Implant Dentistry at Loma Linda University School of Dentistry.
Who may be able to join
- Patient must have a maxillary anterior immediate implant and provisionalization treatment completed.
- The adjacent tooth next to the implant should be a natural tooth
- The temporary crown must have been in place for a minimum of 4 months
- The patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue
- Patient must have generally good oral hygiene without any history of gum disease or gum recession of other teeth around the region of interest
Who cannot join
- Patient with an implant crown that has no teeth next to the implant crown
- Patients who have an active gum disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University - Center of Implant Dentistry
Loma Linda, California, 92350
Center of Implant Dentistry, 909-558-4983, jichung@students.llu.edu
About this study
The study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?"
The area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.
Read the detailed description
When an implant crown is removed, the gum in the area, usually supported by the crown, might go through temporary changes once that support is gone. While the change itself may be temporary, some ways to make a final crown that would be esthetically pleasing might require making a copy of the temporary crown or a mold of the gum around the crown.
This study will involve the removal of an implant crown at a site where a failing tooth was removed, and a dental implant and a crown was placed into the extraction socket. Once the subject enrolls in the study, the area of the implant crown will be scanned right after the removal of the implant crown, and 1, 2, 3, 5, 7, 10, and 15 minutes after the removal of the crown. In order to record the exact location of the implant, a tag will be placed onto the implant and the tag will be scanned as well. The subject's crown will be also scanned so that all the data can be overlaid on top of each other to assess the actual change that occurs. After, the crown will be re-inserted in the patient's mouth so that the gum can rebound back to its original shape.
If the patient is able to return in the near future for a new crown, the patient will be asked to make one final scan of the mouth to see if there is any changes in the gums between that of the old and the new crown. This will show if the shape of the crown under the gums might have an effect on how the gums might look.
The study will look into whether an immediate change might happen, and how much change actually takes place over the 15 minutes, in whichever direction it might happen.
- Conditions
- Tooth Loss, Implant Site Reaction
- Being tested
- intraoral scan
- Keywords
- immediate implant placement, provisional, impression
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoral scanOther
Device that scans the mouth with by taking numerous pictures of the mouth and stitches them together to form a three-dimensional copy of the patient teeth.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant mucosal volumetric change
The mucosal volumetric change will be a composite measurement of the outside and inside portion of the peri-implant gum area by a 3D analyzing software. The 3D image that has been captured from an intra-oral scan will be analyzed during the time interval mentioned in the study description. This measurement is representing the horizontal change, and will be recorded in millimeters (mm). The critical analysis will be placed as changes from 0.5mm. Any change more than 0.5mm will be considered a large amount of change.
Measured: Change between baseline and 15 minutes post initial crown removal
Secondary outcomes (1)
Vertical gingival margin discrepancy
This is the composite measure of the coronal-apical shift of the crown margin once the crown is removed. This would be the vertical change happening when you are looking straight at the subject. The vertical height will be measured from the actual crown margin to the resulting crown margin following crown removal, and the measurement will be recorded as millimeters (mm.) Any change more than 0.5mm will be considered a significant change.
Measured: Change between baseline and 15 minutes post initial crown removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start24 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Kan, DDS, MS, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783595
- Sponsor's protocol ID
- 5230566
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT06783595
- Acronym / sponsor ID
- 5230566
- Conditions
- Tooth Loss, Implant Site Reaction
- Keywords
- immediate implant placement, provisional, impression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jan 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 study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?"
The area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.
Detailed description
When an implant crown is removed, the gum in the area, usually supported by the crown, might go through temporary changes once that support is gone. While the change itself may be temporary, some ways to make a final crown that would be esthetically pleasing might require making a copy of the temporary crown or a mold of the gum around the crown.
This study will involve the removal of an implant crown at a site where a failing tooth was removed, and a dental implant and a crown was placed into the extraction socket. Once the subject enrolls in the study, the area of the implant crown will be scanned right after the removal of the implant crown, and 1, 2, 3, 5, 7, 10, and 15 minutes after the removal of the crown. In order to record the exact location of the implant, a tag will be placed onto the implant and the tag will be scanned as well. The subject's crown will be also scanned so that all the data can be overlaid on top of each other to assess the actual change that occurs. After, the crown will be re-inserted in the patient's mouth so that the gum can rebound back to its original shape.
If the patient is able to return in the near future for a new crown, the patient will be asked to make one final scan of the mouth to see if there is any changes in the gums between that of the old and the new crown. This will show if the shape of the crown under the gums might have an effect on how the gums might look.
The study will look into whether an immediate change might happen, and how much change actually takes place over the 15 minutes, in whichever direction it might happen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected for the participation in the study will be solely from the Center of Implant Dentistry at Loma Linda University School of Dentistry.
Key inclusion criteria (5 listed)
- Patient must have a maxillary anterior immediate implant and provisionalization treatment completed.
- The adjacent tooth next to the implant should be a natural tooth
- The temporary crown must have been in place for a minimum of 4 months
- The patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue
- Patient must have generally good oral hygiene without any history of gum disease or gum recession of other teeth around the region of interest
Key exclusion criteria (2 listed)
- Patient with an implant crown that has no teeth next to the implant crown
- Patients who have an active gum disease
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 |
|---|---|---|
| intraoral scanDevice that scans the mouth with by taking numerous pictures of the mouth and stitches them together to form a three-dimensional copy of the patient teeth. | Other | – |
Primary outcome
Peri-implant mucosal volumetric change
Time frame: Change between baseline and 15 minutes post initial crown removal
The mucosal volumetric change will be a composite measurement of the outside and inside portion of the peri-implant gum area by a 3D analyzing software. The 3D image that has been captured from an intra-oral scan will be analyzed during the time interval mentioned in the study description. This measurement is representing the horizontal change, and will be recorded in millimeters (mm). The critical analysis will be placed as changes from 0.5mm. Any change more than 0.5mm will be considered a large amount of change.
1 secondary outcome
Vertical gingival margin discrepancy
Time frame: Change between baseline and 15 minutes post initial crown removal
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 20 Feb 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.
Joseph Kan, DDS, MS principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Implant Site Reaction, run by Loma Linda 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 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?
Contact Ji Yeon Chung, DDS (9095584983, jichung@students.llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant mucosal volumetric change (time frame: Change between baseline and 15 minutes post initial crown removal). 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 20 Feb 2026.