NCT03851224

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

September 11, 2018

Last Update Submit

February 20, 2019

Conditions

Dental Diseases

Outcome Measures

Primary Outcomes (2)

  • evaliuation of labial bone changes

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

    6 month

  • evaluation of marginal bone changes

    evaluation of interproximal bone changes by millimeter in the CBCT

    6 months

Secondary Outcomes (1)

  • pink aesthetic score

    6 month

Study Arms (3)

control group

ACTIVE COMPARATOR

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

study group

ACTIVE COMPARATOR

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

study group 2

ACTIVE COMPARATOR

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

Interventions

control groupPROCEDURE

immediate implant with immediate loading using no graft

control group
study groupPROCEDURE

immediate implant with immediate loading using autogenous bone graft

study group
study group 2PROCEDURE

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

study group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with non-restorable teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Al- Manial Egypt, 11553, Egypt

RECRUITING

Related Publications (12)

  • 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.

    PMID: 22157097BACKGROUND

  • 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.

    PMID: 348452BACKGROUND

  • 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.

    PMID: 15635942BACKGROUND

  • 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.

    PMID: 17491484BACKGROUND

  • 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.

    PMID: 2098360BACKGROUND

  • 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.

    PMID: 24804291BACKGROUND

  • 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.

    PMID: 7844127BACKGROUND

  • 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.

    PMID: 24804283BACKGROUND

  • 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.

    PMID: 21365054BACKGROUND

  • 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.

    PMID: 24956098BACKGROUND

  • 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.

    PMID: 16987328BACKGROUND

  • 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.

    PMID: 12608666BACKGROUND

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mostafa M Attiea, B.S.D

    Egypt Faculty of dentistry Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa M Attiea, B.S.D

CONTACT

00201009080414mosattiea3110@gmail.com

Mostafa M Attiea, B.S.D

CONTACT

0021009080414ahmed.zayed@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S., principal investigator

Study Record Dates

First Submitted

September 11, 2018

First Posted

February 22, 2019

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

EG(1)