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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03741036
Other study ID # CEBD-CU-27-7-2018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 27, 2018
Est. completion date August 17, 2019

Study information

Verified date November 2018
Source Cairo University
Contact mohamed tarek, master
Phone 01114951862
Email mtm.omar@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization


Description:

Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score [PES]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow‐up of at least 12 months.

The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.

Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.

Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 17, 2019
Est. primary completion date July 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction

- Both sexes.

- No intraoral soft and hard tissue pathology

- No systemic condition that contraindicate implant placemen

Exclusion Criteria:

- Heavy smokers more than 20 cigarettes per day.

- Patients with systemic disease that may affect normal healing.

- Psychiatric problems

- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Autogenous bone graft as space filling in immidiate implant placment
The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft) Patients will be subjected to CBCT (diagnostic for upper arch). Local anesthesia will be given to the patient. Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. The procedure will be carried out flapless. In the study group: Atraumatic extraction The extraction socket will be evaluated for absence of any fenestration or granulation tissues
Deprotinized bovien as space filling in immidate implant placement
The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material) Patients will be subjected to CBCT (diagnostic for upper arch). Local anesthesia will be given to the patient. Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. The procedure will be carried out flapless. In the study group: Atraumatic extraction The extraction socket will be evaluated for absence of any fenestration or granulation tissues
Nano-hydroxiapatite alloplast in immidiate implant placement
The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material ) Patients will be subjected to CBCT (diagnostic for upper arch). Local anesthesia will be given to the patient. Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. The procedure will be carried out flapless. In the study group: Atraumatic extraction The extraction socket will be evaluated for absence of any fenestration or granulation tissues

Locations

Country Name City State
Egypt Cairo University Cairo
Egypt Mohamed tarek Cairo

Sponsors (2)

Lead Sponsor Collaborator
Mohamed tarek mohamed youssif omar Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary stability (marginal bone loss) measure device (osstell ) 3 months
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