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Immediate Implant With no Graft , Autogenous Graft or Xenograft.

Primary Purpose

Dental Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

control group

study group

study group 2

About this trial

This is an interventional health services research trial for Dental Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients with non-restorable teeth

Exclusion Criteria:

intra oral pathology and systemic conditions that contraindicate dental implants.

Sites / Locations

Faculty of Dentistry Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

control group

study group

study group 2

Arm Description

under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with no graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively

under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced with autogenous bone graft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively

under local anaesthesia patients hopeless teeth are be extracted. then immediate implant is palced withxenograft and immediate temporary prothesis is loaded upon the immediate implants.implant stability is evaluated immediately and 3 months post operatively

Outcomes

Primary Outcome Measures

evaliuation of labial bone changes

Evaluation the thickness of the facial bony wall by millimeter in the CBCT

evaluation of marginal bone changes

evaluation of interproximal bone changes by millimeter in the CBCT

Secondary Outcome Measures

pink aesthetic score

evaluation of soft tissue changes surround implant by pink aesthetic score

Full Information

NCT ID

NCT03851224

First Posted

September 11, 2018

Last Updated

February 20, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03851224

Brief Title

Immediate Implant With no Graft , Autogenous Graft or Xenograft.

Official Title

Immediate Implant Placement in Maxillary Esthetic Zone Without Augmenting the Jumping Gap Versus the Use of Autogenous Bone Particulates or Demineralized Bovine Bone Graft (Randomized Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

September 1, 2019 (Anticipated)

Study Completion Date

November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Immediate implant placement with no graft , autogenous graft or xenograft with provisionalization.

Detailed Description

Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft (Randomized Clinical Trial)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Diseases

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.

Masking

Participant

Masking Description

Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Active Comparator

Arm Description

Arm Title

study group

Arm Type

Active Comparator

Arm Description

Arm Title

study group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

control group

Intervention Description

immediate implant with immediate loading using no graft

Intervention Type

Procedure

Intervention Name(s)

study group

Intervention Description

immediate implant with immediate loading using autogenous bone graft

Intervention Type

Procedure

Intervention Name(s)

study group 2

Intervention Description

immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft

Primary Outcome Measure Information:

Title

evaliuation of labial bone changes

Description

Evaluation the thickness of the facial bony wall by millimeter in the CBCT

Time Frame

6 month

Title

evaluation of marginal bone changes

Description

evaluation of interproximal bone changes by millimeter in the CBCT

Time Frame

6 months

Secondary Outcome Measure Information:

Title

pink aesthetic score

Description

evaluation of soft tissue changes surround implant by pink aesthetic score

Time Frame

6 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with non-restorable teeth Exclusion Criteria: intra oral pathology and systemic conditions that contraindicate dental implants.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa M Attiea, B.S.D

Phone

00201009080414

Ext

01111634311

mosattiea3110@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa M Attiea, B.S.D

Phone

0021009080414

Ext

01111634311

ahmed.zayed@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa M Attiea, B.S.D

Organizational Affiliation

Egypt Faculty of dentistry Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry Cairo University

City

Cairo

State/Province

Al- Manial Egypt

ZIP/Postal Code

11553

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mostafa M Attiea, B.S.D

Phone

00201009080414

Ext

01111634311

mosattiea3110@gmail.com

First Name & Middle Initial & Last Name & Degree

Mostafa M Attiea, B.S.D

Phone

00201009080414

Ext

01111634311

ahmed.zayed@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

web sites and papers

Citations:

PubMed Identifier

22157097

Citation

Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.

Results Reference

background

PubMed Identifier

348452

Citation

Schulte W, Kleineikenscheidt H, Lindner K, Schareyka R. [The Tubingen immediate implant in clinical studies]. Dtsch Zahnarztl Z. 1978 May;33(5):348-59. German.

Results Reference

background

PubMed Identifier

15635942

Citation

Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.

Results Reference

background

PubMed Identifier

17491484

Citation

Elian N, Cho SC, Froum S, Smith RB, Tarnow DP. A simplified socket classification and repair technique. Pract Proced Aesthet Dent. 2007 Mar;19(2):99-104; quiz 106.

Results Reference

background

PubMed Identifier

2098360

Citation

Becker W, Becker BE. Guided tissue regeneration for implants placed into extraction sockets and for implant dehiscences: surgical techniques and case report. Int J Periodontics Restorative Dent. 1990;10(5):376-91. No abstract available.

Results Reference

background

PubMed Identifier

24804291

Citation

Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.

Results Reference

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PubMed Identifier

7844127

Citation

Conrad EU, Gretch DR, Obermeyer KR, Moogk MS, Sayers M, Wilson JJ, Strong DM. Transmission of the hepatitis-C virus by tissue transplantation. J Bone Joint Surg Am. 1995 Feb;77(2):214-24. doi: 10.2106/00004623-199502000-00007.

Results Reference

background

PubMed Identifier

24804283

Citation

Tarnow DP, Chu SJ, Salama MA, Stappert CF, Salama H, Garber DA, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Saito H. Flapless postextraction socket implant placement in the esthetic zone: part 1. The effect of bone grafting and/or provisional restoration on facial-palatal ridge dimensional change-a retrospective cohort study. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):323-31. doi: 10.11607/prd.1821.

Results Reference

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PubMed Identifier

21365054

Citation

Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.

Results Reference

background

PubMed Identifier

24956098

Citation

Chu SJ, Hochman MN, Tan-Chu JH, Mieleszko AJ, Tarnow DP. A novel prosthetic device and method for guided tissue preservation of immediate postextraction socket implants. Int J Periodontics Restorative Dent. 2014;34 Suppl 3:s9-17. doi: 10.11607/prd.1749.

Results Reference

background

PubMed Identifier

16987328

Citation

Ritter AV. Xerostomia (dry mouth). J Esthet Restor Dent. 2006;18(5):306. doi: 10.1111/j.1708-8240.2006.00041.x. No abstract available.

Results Reference

background

PubMed Identifier

12608666

Citation

Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):31-9.

Results Reference

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Immediate Implant With no Graft , Autogenous Graft or Xenograft.

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