- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060784
Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield
Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Health
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Loma Linda, California, United States, 92350
- Loma Linda University School of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria (control group)
- 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.
Exclusion Criteria (test group)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate implant placement and provisionalization
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.
|
Failing tooth will be extracted and immediate placed endosseous implant
Other Names:
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Experimental: Socket shield technique
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.
|
Failing tooth will be extracted and immediate placed endosseous implant
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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At baseline (pre-op) and at 12 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Soft tissue volume change
Time Frame: At baseline (pre-op) and 12 months after surgery
|
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
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At baseline (pre-op) and 12 months after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Kan, DDS, Loma Linda dental implant department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5190036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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