Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

NCT ID: NCT04489654

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Immediate Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandra university

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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lubna f elsharkawy, BDS

Role: CONTACT

01200508371

Other Identifiers

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interventional

Identifier Type: -

Identifier Source: org_study_id

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