NCT06566287

Brief Summary

One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 20, 2024

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in implant stability

    The stability of each implant will be measured using the Osstell device. The ISQ value will be measured immediately at the time of surgery and after three months

    Baseline and 3 months

Secondary Outcomes (2)

  • change in thickness of the facial cortical plate

    Baseline and 3 months

  • Change in bone density

    Baseline and 3 months

Study Arms (2)

Group A

EXPERIMENTAL
Other: Immediate implant

Group B

ACTIVE COMPARATOR
Other: Delayed implant

Interventions

Immediate Implant with Socket Shield Group

Group A

Delayed Implant with Socket preserved with socket Shield and dentin graft Group

Group B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with badly destructed or non-restorable maxillary anterior teeth when the Labial cortical plate is still intact, and the thickness was found to be \<2mm in CBCT.
  • Patients with health status according to American Society of Anesthesiology (ASA) I and II.
  • Patients who agree to participate in the study.

You may not qualify if:

  • Patients presenting with any systemic pathology or health condition that would inhibit the osseointegration process of the implants.
  • Perforated labial cortical plate seen in CBCT.
  • Patients undergoing radiation therapy or history of radiation within the last two years.
  • Drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start

January 17, 2023

Primary Completion

December 19, 2023

Study Completion

December 19, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations