- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851224
Immediate Implant With no Graft , Autogenous Graft or Xenograft.
February 20, 2019 updated by: mostafa attiea, Cairo University
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)
Immediate implant placement with no graft , autogenous graft or xenograft with provisionalization.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mostafa M Attiea, B.S.D
- Phone Number: 01111634311 00201009080414
- Email: mosattiea3110@gmail.com
Study Contact Backup
- Name: Mostafa M Attiea, B.S.D
- Phone Number: 01111634311 0021009080414
- Email: ahmed.zayed@dentistry.cu.edu.eg
Study Locations
-
-
Al- Manial Egypt
-
Cairo, Al- Manial Egypt, Egypt, 11553
- Recruiting
- Faculty of dentistry cairo university
-
Contact:
- Mostafa M Attiea, B.S.D
- Phone Number: 01111634311 00201009080414
- Email: mosattiea3110@gmail.com
-
Contact:
- Mostafa M Attiea, B.S.D
- Phone Number: 01111634311 00201009080414
- Email: ahmed.zayed@dentistry.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with non-restorable teeth
Exclusion Criteria:
- intra oral pathology and systemic conditions that contraindicate dental implants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
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
|
immediate implant with immediate loading using no graft
|
Active Comparator: study group
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
|
immediate implant with immediate loading using autogenous bone graft
|
Active Comparator: study group 2
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
|
immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaliuation of labial bone changes
Time Frame: 6 month
|
Evaluation the thickness of the facial bony wall by millimeter in the CBCT
|
6 month
|
evaluation of marginal bone changes
Time Frame: 6 months
|
evaluation of interproximal bone changes by millimeter in the CBCT
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pink aesthetic score
Time Frame: 6 month
|
evaluation of soft tissue changes surround implant by pink aesthetic score
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mostafa M Attiea, B.S.D, Egypt Faculty of dentistry Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
February 20, 2019
First Posted (Actual)
February 22, 2019
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- immediate implants
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
web sites and papers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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