Immediate Implant With no Graft , Autogenous Graft or Xenograft.

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03851224
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Diseases	Procedure: control group; Procedure: study group; Procedure: study group 2	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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: Single (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.
• Primary Purpose: Health Services Research
• 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)
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Nov 1, 2019

Arms and Interventions

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	Procedure: control group; 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	Procedure: study group; 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	Procedure: study group 2; immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft

Outcome Measures

Primary Outcome Measures

1. evaliuation of labial bone changes [6 month]

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

2. evaluation of marginal bone changes [6 months]

   evaluation of interproximal bone changes by millimeter in the CBCT

Secondary Outcome Measures

1. pink aesthetic score [6 month]

   evaluation of soft tissue changes surround implant by pink aesthetic score

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients with non-restorable teeth

Exclusion Criteria:

• intra oral pathology and systemic conditions that contraindicate dental implants.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry Cairo University	Cairo	Al- Manial Egypt	Egypt	11553

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Mostafa M Attiea, B.S.D, Egypt Faculty of dentistry Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Chen ST, Wilson TG Jr, Hämmerle 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• Ritter AV. Xerostomia (dry mouth). J Esthet Restor Dent. 2006;18(5):306.
• Schulte W, Kleineikenscheidt H, Lindner K, Schareyka R. [The Tübingen immediate implant in clinical studies]. Dtsch Zahnarztl Z. 1978 May;33(5):348-59. German.
• 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.
• 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.

• Responsible Party: mostafa attiea, B.D.S., principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03851224
• Other Study ID Numbers: immediate implants
• First Posted: Feb 22, 2019
• Last Update Posted: Feb 22, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomatognathic Diseases

Study Results

No Results Posted as of Feb 22, 2019