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

Tooth Socket Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047861
• Other study ID #: Socket shield_2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: September 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Teeth Extraction
• Tooth Socket

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in bone density	it will be measured using CBCT	at baseline and 3 months
Primary	change in bone height	it will be measured using CBCT	at baseline and 3 months
Primary	change in Labio/Bucco-Palatal width	it will be measured using CBCT	at baseline and 3 months