Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material

Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological 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 autogenous dentine was introduced to preserve the periodontal ligaments.

this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.

Study Overview

• Status: Completed
• Conditions: Extraction Tooth Socket
• Intervention / Treatment: Procedure: Modified socket shield technique with autogenous dentin graft material (in one side); Procedure: Modified socket shield technique with alloplast graft material (in contralateral side)

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 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 maxillary aesthetic regions (incisors, premolars) in both side
• Intact labial periodontal tissues.
• 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, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
• Untreated periodontal disease.
• Vertical root fractures on the labial aspect.
• Tooth /teeth with horizontal fractures below bone level.
• Tooth /teeth with external or internal resorptions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (in one side); Modified socket shield technique with autogenous dentin graft	Procedure: Modified socket shield technique with autogenous dentin graft material (in one side); The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix.
Active Comparator: Control group (in contrlateral side); Modified socket shield technique with alloplast	Procedure: Modified socket shield technique with alloplast graft material (in contralateral side); The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post opertaive edema	This will be assessed in the 1st week postoperatively and measured as follows: None (no inflammation) Mild (intraoral swelling confined to the surgical field) Moderate (extraoral swelling in the surgical zone) Severe (extraoral swelling spreading beyond the surgical zone).	after 7 days
change in pain score	it will be assessed using VAS It rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain	1 week and 3 months
Change in bone density	it will be assessed using CBCT	at baseline and 3 months
Change in bone height	it will be assessed using CBCT	at baseline and 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 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): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: socket preservation_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