Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

NCT04489654 | Unknown

• 1 other identifier: interventional
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immediate Implant

Outcome Measures

Primary Outcomes (1)

• primary and secondary implant stability measurement

  Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell

  4 months

Secondary Outcomes (1)

• Bone mineral density

  6 months

Study Arms (2)

study

ACTIVE COMPARATOR

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)

control

NO INTERVENTION

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

Interventions

deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany) BIOLOGICAL

deproteinized bovine bone mineral (DBBM) put in the gap between implant and labial shield

study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandra university

Alexandria, Egypt

RECRUITING

Central Study Contacts

lubna f elsharkawy, BDS

CONTACT

01200508371; lubna_elsharkawy@Hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 28, 2020
• Study Start: July 20, 2019
• Primary Completion: August 14, 2020
• Study Completion: October 1, 2020
• Last Updated: July 28, 2020

Record last verified: 2019-07

Locations

EG (1)