Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield

Anterior Teeth Clinical Trial

Official title:

Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060784
• Other study ID #: 5190036
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: March 29, 2023

Study information

• Verified date: August 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Teeth

Intervention

Procedure:
• Immediate implant placement and provisionalization
Failing tooth will be extracted and immediate placed endosseous implant

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California
United States	Loma Linda University school of dentistry	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Nobel Biocare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial gingival level change	The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op	At baseline (pre-op) and at 12 months after surgery
Secondary	Soft tissue volume change	The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op	At baseline (pre-op) and 12 months after surgery