Immediate and Delayed Implant Placement Using Socket Shield Technique and Autogenous Dentin Graft

Immediate And Delayed Implant Placement Using Socket Shield Technique And Autogenous Dentin Graft (A Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss; Dental Implant; Socket Shield
• Intervention / Treatment: Other: Immediate implant; Other: Delayed implant

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Other: Immediate implant; Immediate Implant with Socket Shield Group
Active Comparator: Group B	Other: Delayed implant; Delayed Implant with Socket preserved with socket Shield and dentin graft Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in thickness of the facial cortical plate	patients will be subjected to CBCT scans	Baseline and 3 months
Change in bone density	patients will be subjected to CBCT scans	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 0629-2/2023

Drug and device information, study documents

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