Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

Immediate Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489654
• Other study ID #: interventional
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2019
• Source: Alexandria University
• Contact: lubna f elsharkawy, BDS
• Phone: 01200508371
• Email: lubna_elsharkawy[@]Hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: October 1, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Implant

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandra university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary and secondary implant stability measurement	Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell	4 months
Secondary	Bone mineral density	Bone mineral density is calculated through radiographic evaluation by means of cone beam CT	6 months