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

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

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

Study Overview

• Status: Unknown
• Conditions: Dental Implant Failed
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt
    • Mohamed tarek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary stability (marginal bone loss)	measure device (osstell )	3 months

Collaborators and Investigators

• Sponsor: Mohamed tarek mohamed youssif omar
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 27, 2018
• Primary Completion (Anticipated): July 27, 2019
• Study Completion (Anticipated): August 17, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: bone graft; dental implant; immidiate; immidiate provisionalization
• Other Study ID Numbers: CEBD-CU-27-7-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No