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

Alveolar and Soft Tissue Changes Surrounding Immediate Implant in the Mandibular Molars With and Without Using Sealing Socket Abutment Technique (Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Mass
• Intervention / Treatment: Device: cover screw; Device: Sealing Socket Abutment

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed zahran, master; Phone Number: 00201118111027; Email: zahran434@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Cairo Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cover screw; extraction of hopeless mandibular molars followed by immediate implants that will be covered using cover screw	Device: cover screw; immediate implant placement in mandibular molar area will be covered with conventional cover screw
Experimental: sealing socket abutment; extraction of hopeless mandibular molars followed by immediate implants that will be covered using sealing socket abutment	Device: 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; Other Names: Anatomic Harmony Abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone loss	The marginal bone on the buccal and lingual surface of the dental implant cannot be assessed with periapical views in millimeters from fixed point . Using the same exposure parameter settings selected after a pilot test and images reconstructed with the same slice thickness and a cutting direction for histological matching to compare preoperative and postoperative.	18 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: mohamed atef, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 01118111027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No