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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04489654
Enrollment
16
Registered
2020-07-28
Start date
2019-07-20
Completion date
2020-10-01
Last updated
2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant

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.

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.

Interventions

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

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
primary and secondary implant stability measurement4 monthsImplant stability measured in units ISQ is concluded through a clinical evaluation using ostell

Secondary

MeasureTime frameDescription
Bone mineral density6 monthsBone mineral density is calculated through radiographic evaluation by means of cone beam CT

Countries

Egypt

Contacts

Primary Contactlubna f elsharkawy, BDS
lubna_elsharkawy@Hotmail.com01200508371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026