Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft

Sponsor

Alexandria University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04489654

Collaborator

(none)

Enrollment

Location

Arms

14.4

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immediate Implant	Biological: deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2019

Anticipated Primary Completion Date :

Aug 14, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

primary and secondary implant stability measurement [4 months]
Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell

Secondary Outcome Measures

Bone mineral density [6 months]
Bone mineral density is calculated through radiographic evaluation by means of cone beam CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandra university	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandria University

ClinicalTrials.gov Identifier:

NCT04489654

Other Study ID Numbers:

interventional

First Posted:

Jul 28, 2020

Last Update Posted:

Jul 28, 2020

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 28, 2020