Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04489654
Other study ID # interventional
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06040788 - Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment N/A
Not yet recruiting NCT05946954 - Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence N/A
Not yet recruiting NCT05891990 - Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence N/A
Completed NCT05020405 - The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation N/A
Active, not recruiting NCT06241196 - Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft Phase 2
Not yet recruiting NCT05431998 - Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. N/A
Completed NCT04731545 - Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone N/A
Completed NCT05878392 - Immediate Implant With Different Filling Materials N/A