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

NCT03667261 | Completed

• 1 other identifier: 01118111027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Mass

Outcome Measures

Primary Outcomes (1)

• Soft tissue changes around implant

  The PES comprises the following five variables: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue, color and texture at the facial aspect of the site. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14 at time of surgery and at the time of final prothesis. All ten parameters are assessed by direct comparison with the contralateral tooth and a score of 2, 1, or 0 is assigned to all ten parameters. Thus, a maximum total PES of 10 can be reached which represents the optimum condition of the soft tissues of the rehabilitated site compared to the characteristics of the contralateral natural tooth.

  18 months

Secondary Outcomes (1)

• marginal bone loss

  18 months

Study Arms (2)

cover screw

ACTIVE COMPARATOR

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

Device: cover screw

sealing socket abutment

EXPERIMENTAL

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

Device: Sealing Socket Abutment

Interventions

Sealing Socket Abutment 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

Also known as: Anatomic Harmony Abutment

sealing socket abutment

cover screw DEVICE

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

cover screw

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Universty

Cairo, 002, Egypt

Location

Study Officials

• mohamed atef

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded as well as the data analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical research

Model Details: cases with with hopeless mandibular molars followed by immediate implant placement

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: September 12, 2018
• Study Start: September 1, 2018
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

EG (1)