Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast

Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.

This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Socket; Teeth Extraction
• Intervention / Treatment: Procedure: socket shield technique with autogenous dentin graft; Procedure: socket shield technique with alloplast graft

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
• Intact labial/buccal periodontal tissues.
• Sufficient bone volume to allow placement of an implant.
• Non-Smoker
• Ability to read and sign an informed consent form

Exclusion Criteria:

• A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
• Untreated periodontal disease. [15,18]
• Vertical root fractures on the buccal aspect. [26]
• Tooth /teeth with horizontal fractures below bone level. [26]
• Tooth /teeth with external or internal resorptions.

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: Study group; patients will receive the implant in the previously preserved socket using Socket shield technique with Alloplastic graft material	Procedure: socket shield technique with autogenous dentin graft; The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level. The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur. The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption. The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur. The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield. After the final preparation of the socket shield, Graft will be placed using autogenous dentin graft from the discarded palatal part of the tooth
Active Comparator: Control group; patients will receive the implant in the previously preserved socket shield with Autogenous dentin graft	Procedure: socket shield technique with alloplast graft; The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level. The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur. The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption. The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur. The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield. After final preparation of socket shield, Graft will be placed Alloplast graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant stability	it will be measured using Osstell ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.	immeditely and at 3 months
change in bone density	it will be measured using CBCT	at baseline and 3 months
change in bone height	it will be measured using CBCT	at baseline and 3 months
change in Labio/Bucco-Palatal width	it will be measured using CBCT	at baseline and 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Socket shield_2020

Drug and device information, study documents

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