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

NCT05047861 | Unknown

• 1 other identifier: Socket shield_2020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Teeth Extraction; Tooth Socket

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

patients will receive the implant in the previously preserved socket shield with Autogenous dentin graft

Procedure: socket shield technique with alloplast graft

Interventions

socket shield technique with autogenous dentin graft PROCEDURE

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

Study group

socket shield technique with alloplast graft PROCEDURE

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

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

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 DPH and Clinical statistician

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 17, 2021
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

EG (1)