Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone

Sponsor

Mohamed tarek mohamed youssif omar (Other)

Overall Status

Unknown status

CT.gov ID

NCT03741036

Collaborator

Cairo University (Other)

Enrollment

Locations

Arms

8.6

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Implant Failed	Procedure: Autogenous bone graft as space filling in immidiate implant placment Procedure: Deprotinized bovien as space filling in immidate implant placement Procedure: Nano-hydroxiapatite alloplast in immidiate implant placement	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Immediate Implant Placement With Provisionalization Using Autogenous Bone Graft Particulates vs Deproteinized Bovine Bone vs Nano-hydroxyapatite Alloplast as a Space Filling Material in the Maxillary Esthetic Zone

Anticipated Study Start Date :

Nov 27, 2018

Anticipated Primary Completion Date :

Jul 27, 2019

Anticipated Study Completion Date :

Aug 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: autogenous bone graft as a space filling material Autogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket	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
Active Comparator: deproteinized bovine as a space filling material Granules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm.	Procedure: 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
Active Comparator: nano-hydroxyapatite alloplast as a space filling material The patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: autogenous bone graft as a space filling material

Autogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket

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

Active Comparator: deproteinized bovine as a space filling material

Granules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm.

Procedure: 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

Active Comparator: nano-hydroxyapatite alloplast as a space filling material

The patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket

Procedure: 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

Outcome Measures

Primary Outcome Measures

Primary stability (marginal bone loss) [3 months]
measure device (osstell )

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt
2	Mohamed tarek	Cairo		Egypt

Sponsors and Collaborators

Mohamed tarek mohamed youssif omar
Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed tarek mohamed youssif omar, Researcher, Cairo University

ClinicalTrials.gov Identifier:

NCT03741036

Other Study ID Numbers:

CEBD-CU-27-7-2018

First Posted:

Nov 14, 2018

Last Update Posted:

Nov 19, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Mohamed tarek mohamed youssif omar, Researcher, Cairo University

immidiate

dental implant

immidiate provisionalization

bone graft

Study Results

No Results Posted as of Nov 19, 2018