Clinical trial NCT03667261: Using Sealing Socket Abutment Technique With Immediate Implant in the Mandibular Molars
Official title: Alveolar and Soft Tissue Changes Surrounding Immediate Implant in the Mandibular Molars With and Without Using Sealing Socket Abutment Technique (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Mass
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cases with with hopeless mandibular molars followed by immediate implant placement
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Soft tissue changes around implant
timeFrame: 18 months
Secondary outcomes:
measure: marginal bone loss
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Universty
Study officials:
affiliation: Cairo University
name: mohamed atef
role: PRINCIPAL_INVESTIGATOR
References: