Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield

NCT04060784 | Completed

• 1 other identifier: 5190036
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Teeth

Keywords

Immediate implant placement and provisionalization; Socket shield technique; Root shield; Soft tissue level change; Soft tissue volume change; IIPP; SST

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Soft tissue volume change

  At baseline (pre-op) and 12 months after surgery

Study Arms (2)

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.

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.

Procedure: Immediate implant placement and provisionalization

Interventions

Immediate implant placement and provisionalization PROCEDURE

Failing tooth will be extracted and immediate placed endosseous implant

Also known as: Socket shield technique

Immediate implant placement and provisionalization; Socket shield technique

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead
• Nobel Biocare: collaborator

Study Sites (2)

Loma Linda University school of dentistry

Loma Linda, California, 92350, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Joseph Kan, DDS

  Loma Linda dental implant department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be blind. Intraexaminer reliability will be performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: August 30, 2019
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (2)