Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield

NCT ID: NCT04060784

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2023-03-29

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.

Conditions

Anterior Teeth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immediate implant placement and provisionalization

Intervention Type: PROCEDURE

Failing tooth will be extracted and immediate placed endosseous implant

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.

Group Type: EXPERIMENTAL

Immediate implant placement and provisionalization

Intervention Type: PROCEDURE

Failing tooth will be extracted and immediate placed endosseous implant

Interventions

Immediate implant placement and provisionalization

Failing tooth will be extracted and immediate placed endosseous implant

Intervention Type: PROCEDURE

Other Intervention Names

Socket shield technique

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

• 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.

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Kan, DDS

Role: PRINCIPAL_INVESTIGATOR

Loma Linda dental implant department

Locations

Loma Linda University school of dentistry

Loma Linda, California, United States

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Other Identifiers

5190036

Identifier Type: -

Identifier Source: org_study_id