Anterior TeethNCT04060784
Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield
A study testing Immediate implant placement and provisionalization in people with Anterior Teeth, run by Loma Linda University at 2 sites in United States.
Trial summary
The purpose of this clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield technique. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anterior Teeth
- What is being tested?
- Immediate implant placement and provisionalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2019to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 21 years of age or older and able to consent to treatment.
- Good oral hygiene. Patient's oral hygiene should be control to a certain level before start the procedure: Plaque Index (PI) score19 ≤20% and Papillary Bleeding Index (PBI) score20 of less than 5%
- Have a single failing maxillary anterior tooth with periodontally healthy adjacent teeth.
- No active infection associated with the failing tooth
- An extraction socket that will allow a facial implant-socket space of ≥2mm after placement of an implant with a minimum dimensions of 3.0 mm diameter and 13.0 mm in length.
- Presence of opposing dentition (natural teeth, fixed or removable prostheses)
Who cannot join
- Systemic disease and/or associated medications that could interfere with implant therapy.
- Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion.
- Smoker.
- History of head and neck radiation.
- Pregnant patient, intending to conceive or breast feeding.
- Soft tissue defect (inflammation, tissue cleft, recession, papilla loss, unhealthy tissue) around a future implant site.
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- Systemic disease and/or associated medications that could interfere with implant therapy.
- Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion.
- Smoker.
- History of head and neck radiation.
- Pregnant patient, intending to conceive or breast feeding.
- Soft tissue defect (inflammation, tissue cleft, recession, papilla loss, unhealthy tissue) around a future implant site.
- Teeth with active infection like periodontal disease, periapical lesions.
- Teeth with vertical root fractures on the buccal aspect, horizontal fracture at or below buccal bone level.
- Teeth with any other pathologies affecting the buccal part of the root, like external or internal resorptions.
- History of head and neck radiation.
- Any mobility of the extraction tooth.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University school of dentistry
Loma Linda, California, 92350
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study
The purpose of this clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield technique.
Read the detailed description
Immediate implant placement and provisionalization, short for IIPP, is one of a very viable option for failing anterior teeth. It has been advocated with documented success for more than 20 years. Despite the decent results, the challenges remains on the altered of the facial implant tissue architecture. To avoid the facial contour change and the possible following esthetic problem, clinicians have tried several ways to preserve the contour, like bone grafting in the gap between the facial bone and implant, or enhance facial gingival tissue thickness through augmentation procedures.
The concept of retaining part of the root, or root shield in conjunction with IIPP was proposed around 8 to 9 years ago. So-called socket shield technique. It has claimed to have successfully preserve the facial contour. Animal studies and couple clinical studies have showed decent results.
The purpose of this clinical controlled study is to compare the facial gingival level change between IIPP with bone graft and with socket shield technique. There are two groups in this study, 13 patients each. Extrusion criteria including male under 21 years old, female under 23 years old, smoker, pregnant patient, history of head and neck radiation, soft tissue defect like inflammation, recession, active infection. On the control group, patient will received IIPP with bone graft; On the test group, IIPP and socket shield technique will be provided. All clinical examinations and data collections will be performed by one investorgator, who will do the measurement at presurgical appointment, Tps, the time of implant placement, Tm0, 6-months Tm6, and 12-months after implant placement Tm12. Data analysis will be blind. Intraexaminer reliability will be performed.
We are looking at 12 elements in this study. The main variable will be facial gingival level change. We will use Intraoral scanner and the 3D images obtained at different time point will be superimposed, to see if there is any significant change between two groups.
- Conditions
- Anterior Teeth
- Being tested
- Immediate implant placement and provisionalization
- Keywords
- Immediate implant placement and provisionalization, Socket shield technique, Root shield, Soft tissue level change, Soft tissue volume change, IIPP, SST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement and provisionalizationProcedure or surgery
Also called Socket shield technique
Failing tooth will be extracted and immediate placed endosseous implant
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement and provisionalization | Experimental | On the control group, Implant will be placed immediately after tooth extraction. The gap between the implant and buccal bone will be filled with bone graft. Temporary crown will be attached to implant fixture. Receives: Procedure: Immediate implant placement and provisionalization |
| Socket shield technique | Experimental | On the test group, Implant will be placed immediately after tooth extraction. A piece of root shield will be retained intentionally at facial side. Temporary crown will attached to implant fixture. Receives: Procedure: Immediate implant placement and provisionalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial gingival level change
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
Measured: At baseline (pre-op) and at 12 months after surgery
Secondary outcomes (1)
Soft tissue volume change
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
Measured: At baseline (pre-op) and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start30 Aug 2019
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior TeethStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in this study, 13 patients each. Subjects who fulfill the inclusion criteria with one failing anterior tooth will be included into this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare
- Responsible party
- Sponsor
- Investigators
- Joseph Kan, DDS, Principal investigator, Loma Linda dental implant department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060784
- Sponsor's protocol ID
- 5190036
- Status last verified
- Nov 2024
- First submitted
- 16 Aug 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study
- ClinicalTrials.gov ID
- NCT04060784
- Acronym / sponsor ID
- 5190036
- Conditions
- Anterior Teeth
- Keywords
- Immediate implant placement and provisionalization, Socket shield technique, Root shield, Soft tissue level change, Soft tissue volume change, IIPP, SST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Nobel Biocare
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 19 Aug 2019 (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 clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield technique.
Detailed description
Immediate implant placement and provisionalization, short for IIPP, is one of a very viable option for failing anterior teeth. It has been advocated with documented success for more than 20 years. Despite the decent results, the challenges remains on the altered of the facial implant tissue architecture. To avoid the facial contour change and the possible following esthetic problem, clinicians have tried several ways to preserve the contour, like bone grafting in the gap between the facial bone and implant, or enhance facial gingival tissue thickness through augmentation procedures.
The concept of retaining part of the root, or root shield in conjunction with IIPP was proposed around 8 to 9 years ago. So-called socket shield technique. It has claimed to have successfully preserve the facial contour. Animal studies and couple clinical studies have showed decent results.
The purpose of this clinical controlled study is to compare the facial gingival level change between IIPP with bone graft and with socket shield technique. There are two groups in this study, 13 patients each. Extrusion criteria including male under 21 years old, female under 23 years old, smoker, pregnant patient, history of head and neck radiation, soft tissue defect like inflammation, recession, active infection. On the control group, patient will received IIPP with bone graft; On the test group, IIPP and socket shield technique will be provided. All clinical examinations and data collections will be performed by one investorgator, who will do the measurement at presurgical appointment, Tps, the time of implant placement, Tm0, 6-months Tm6, and 12-months after implant placement Tm12. Data analysis will be blind. Intraexaminer reliability will be performed.
We are looking at 12 elements in this study. The main variable will be facial gingival level change. We will use Intraoral scanner and the 3D images obtained at different time point will be superimposed, to see if there is any significant change between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups in this study, 13 patients each. Subjects who fulfill the inclusion criteria with one failing anterior tooth will be included into this study.
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement and provisionalization | Experimental | Procedure: Immediate implant placement and provisionalizationOn the control group, Implant will be placed immediately after tooth extraction. The gap between the implant and buccal bone will be filled with bone graft. Temporary crown will be attached to implant fixture. |
| Socket shield technique | Experimental | Procedure: Immediate implant placement and provisionalizationOn the test group, Implant will be placed immediately after tooth extraction. A piece of root shield will be retained intentionally at facial side. Temporary crown will attached to implant fixture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 21 years of age or older and able to consent to treatment.
- Good oral hygiene. Patient's oral hygiene should be control to a certain level before start the procedure: Plaque Index (PI) score19 ≤20% and Papillary Bleeding Index (PBI) score20 of less than 5%
- Have a single failing maxillary anterior tooth with periodontally healthy adjacent teeth.
- No active infection associated with the failing tooth
- An extraction socket that will allow a facial implant-socket space of ≥2mm after placement of an implant with a minimum dimensions of 3.0 mm diameter and 13.0 mm in length.
Key exclusion criteria (17 listed)
- Systemic disease and/or associated medications that could interfere with implant therapy.
- Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion.
- Smoker.
- History of head and neck radiation.
- Pregnant patient, intending to conceive or breast feeding.
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 |
|---|---|---|
| Immediate implant placement and provisionalizationAlso: Socket shield techniqueFailing tooth will be extracted and immediate placed endosseous implant | Procedure or surgery | Immediate implant placement and provisionalization, Socket shield technique |
Primary outcome
Facial gingival level change
Time frame: At baseline (pre-op) and at 12 months after surgery
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
1 secondary outcome
Soft tissue volume change
Time frame: At baseline (pre-op) and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Kan, DDS principal investigator
Loma Linda dental implant department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement and provisionalization in people with Anterior Teeth, run by Loma Linda University at 2 sites 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Facial gingival level change (time frame: At baseline (pre-op) and at 12 months after surgery). 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 Nov 2024.