Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

Evaluation of Immediate Implant Placement With a Modified Socket Shield Technique Using Xenogenic Bone Graft. (a Randomized Controlled Clinical Trial) CLINICAL TRIAL)

Adequate bone volume and a proper aesthetic outcome have become the main focus of interest in implant dentistry. Alveolar bone resorption is a natural course occurring after tooth removal. Partial extraction therapy through root preservation has been reported to help in bone maintenance at the extraction site. In 2010, Hurzeler et al. evaluated a new approach, at that time, called socket shield technique. Han et al. in 2018 reported the modification of this technique and leaving the jump gap between the shield and the implant non-grafted. The importance of bone grafting of the gap between the implant and the labial shield in improving quality of regenerating bone and prevention of the soft tissue ingrowth has been described. Thus the hypothesis, of improving the modified socket shield technique by bone grafting could be tested.

Aim of this study is to evaluate the clinical and radiographic outcomes of using xenogenic bone graft on outcome of immediate dental implant placement using the modified socket shield technique.

Study Overview

• Status: Unknown
• Conditions: Immediate Implant
• Intervention / Treatment: Biological: deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany)

Detailed Description

16 patients who are admitted to the outpatient clinic of Oral and Maxillofacial Surgery Department, are divided into two study groups. Control group will receive an immediate implant with modified socket shield technique. Test group will receive immediate implant with modified socket shield and deproteinized bovine bone mineral (DBBM) put in the buccal gap. Outcome measurement is primary and secondary implant stability measurement and CBCT evaluation.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandra university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age more than 18 years old irrespective of the gender
• One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
• Free from periodontal diseases.
• Sufficient bone volume to allow placement of an implant.
• Ability to read and sign an informed consent form
• Adequate buccolingual width to allow for a buccal gap presence.

Exclusion Criteria:

• A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosphonates).
• Untreated periodontal disease.
• Vertical root fractures on the buccal 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: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study; Test group will receive immediate implant with modified socket shield and deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) put in the buccal gap	Biological: deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany); deproteinized bovine bone mineral (DBBM) put in the gap between implant and labial shield
No Intervention: control; Control group will receive an immediate implant with modified socket shield technique but without deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) in the buccal gap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary and secondary implant stability measurement	Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density	Bone mineral density is calculated through radiographic evaluation by means of cone beam CT	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2019
• Primary Completion (Anticipated): August 14, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

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