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

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05047861

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Teeth Extraction Tooth Socket	Procedure: socket shield technique with autogenous dentin graft Procedure: socket shield technique with alloplast graft	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in implant stability [immeditely and at 3 months]
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.
change in bone density [at baseline and 3 months]
it will be measured using CBCT
change in bone height [at baseline and 3 months]
it will be measured using CBCT
change in Labio/Bucco-Palatal width [at baseline and 3 months]
it will be measured using CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita	Egypt	00203

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT05047861

Other Study ID Numbers:

Socket shield_2020

First Posted:

Sep 17, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 17, 2021