NCT03394625

Brief Summary

Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of bone. After tooth extraction physiological process occur causing alteration of bone and soft tissue so, delayed placement of implant lead to loss of bone height and width. Immediate placement of implant is become essential to preserve the bone and soft tissue from loss. Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. This technique allow preservation of buccal plate of bone and soft tissue with minimum loss allowing better result in esthetic zone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

December 27, 2017

Last Update Submit

September 5, 2018

Conditions

Keywords

Socket Shieldimmediate implantridge preservation

Outcome Measures

Primary Outcomes (1)

  • marginal bone loss

    will be measured from CBCT using Blue-sky software built-in linear measuring tool by millimeters

    4 months

Study Arms (2)

immediate implant placement using socket shield technique

EXPERIMENTAL

Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.

Procedure: Socket shield technique

immediate implant placement using xenograft material

ACTIVE COMPARATOR

placing xenograft material in gap between implant and buccal bone

Procedure: using Xenograft material

Interventions

Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.

immediate implant placement using socket shield technique

placing xenograft material in gap between the implant and the buccal plate of bone

immediate implant placement using xenograft material

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with badly broken teeth in upper esthetic zone with intact periodontal condition indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • Physically able to tolerate conventional surgical and restorative procedures.
  • Signing of an informed consent form.

You may not qualify if:

  • Presence of fenestrations or dehiscence of the residual bony walls after extraction.
  • Heavy smokers more than 20 cigarettes per day .(24)
  • Patients with systemic disease that may affect normal healing e.g. uncontrolled diabetes.
  • Psychiatric problems e.g. severe bruxism.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Active infection in the teeth to be treated
  • Vertical root fractures with displacement in the teeth of the surgical area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 9, 2018

Study Start

July 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 20, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations