Clinical trial NCT04060784: Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield
Official title: Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Teeth
Keywords: Immediate implant placement and provisionalization
Socket shield technique
Root shield
Soft tissue level change
Soft tissue volume change
IIPP
SST
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
First posted: 2019-08-19
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial gingival level change
timeFrame: At baseline (pre-op) and at 12 months after surgery
Secondary outcomes:
measure: Soft tissue volume change
timeFrame: At baseline (pre-op) and 12 months after surgery
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University school of dentistry
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda dental implant department
name: Joseph Kan, DDS
role: PRINCIPAL_INVESTIGATOR
References: