Using Sealing Socket Abutment Technique With Immediate Implant in the Mandibular Molars

NCT ID: NCT03667261

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-02-20

Brief Summary

First and second molar locations present major challenges when immediate implant placement is planned due to large extraction sockets that are difficult to seal without mucoperiosteal flap reflection which is less comfortable to patient and also crestal socket morphology not amenable to standard healing abutment which have circular shape and the possibility of high occlusal forces during function with complete provisional crown.Immediate implant placement without sealing socket abutment has several drawbacks, such as collapse of existing soft tissue and also it needs second stage surgery which is less comfortable to patient and chair time consuming for the operator.

Detailed Description

The anatomical changes that occur with the alveolar ridge after the loss of tooth can be a challenge to redevelop during the restorative process. The preservation of the soft tissue level from the time of extraction may optimize the final prosthetic outcome. One technique that can be used to achieve ideal tissue form is immediate dental implant placement with a custom-healing abutment.

Immediate implant placement followed by immediate provisional restoration of single sites is a protocol used to replace a failing tooth. This technique may benefit patients with a thin periodontal biotype. Another benefit is the simplification of the final restorative procedure. Pre-fabricated healing abutments are circular in shape. Attempts at molding the tissue from a small opening above the implant to a contour similar to the missing tooth can take time. The preserved tissue profile can be easily duplicated in the impression process and allow for an accurate fabrication of a restoration in harmony with ideal tissue architecture at the day of insertion.

This form of maintenance of the supporting gingival tissue has been demonstrated to be beneficial using immediate pontics for tooth replacement. Preservation of form, rather than re-creation, is achieved with the extension of the pontic into the subgingival zone with a contour replicating that of the extracted tooth. Concepts from immediate pontics have been applied to immediate dental implants with a similar goal. This is achieved with either a custom healing abutment or a complete provisional crown. The use of a custom-healing abutment is recommended in patients who have a deep anterior bite, who present with signs of bruxism, or who have a malocclusion that is not conducive to the protection of an immediate restoration.

Conditions

Soft Tissue Mass

Study Design

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

Study Groups

cover screw

extraction of hopeless mandibular molars followed by immediate implants that will be covered using cover screw

Group Type: ACTIVE_COMPARATOR

cover screw

Intervention Type: DEVICE

immediate implant placement in mandibular molar area will be covered with conventional cover screw

sealing socket abutment

extraction of hopeless mandibular molars followed by immediate implants that will be covered using sealing socket abutment

Group Type: EXPERIMENTAL

Sealing Socket Abutment

Intervention Type: DEVICE

Sealing Socket Abutment (SSA) serves as a mechanical barrier to isolate the grafted area, stabilize the clot and contain the graft material, and seal the socket from foreign contaminants and also minimizing the risk of premature loading of the implant during healing. By preparing an SSA fabricated to follow the transmucosal contours of the natural tooth, the grafted area can be sealed and separated from the growth of soft tissue without the use of a membrane or releasing incisions

Interventions

Sealing Socket Abutment

Sealing Socket Abutment (SSA) serves as a mechanical barrier to isolate the grafted area, stabilize the clot and contain the graft material, and seal the socket from foreign contaminants and also minimizing the risk of premature loading of the implant during healing. By preparing an SSA fabricated to follow the transmucosal contours of the natural tooth, the grafted area can be sealed and separated from the growth of soft tissue without the use of a membrane or releasing incisions

Intervention Type: DEVICE

cover screw

immediate implant placement in mandibular molar area will be covered with conventional cover screw

Intervention Type: DEVICE

Other Intervention Names

Anatomic Harmony Abutment

Eligibility Criteria

Inclusion Criteria

• Patients with hopeless molars in the posterior area of the mandible.
• Both sexes.
• No intraoral soft and hard tissue pathology
• No systemic condition that contraindicate implant placement

Exclusion Criteria

• Very thin less than 0.5 mm or absent buccal plate.
• Heavy smokers more than 10 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems
• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Amen Zahran

clinical research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed atef

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo Universty

Cairo, , Egypt

Countries

Egypt

Other Identifiers

01118111027

Identifier Type: -

Identifier Source: org_study_id