NCT03243695

Brief Summary

patients with fractured teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

August 4, 2017

Last Update Submit

June 6, 2020

Conditions

Immediate Dental Implants

Keywords

immediate implants, implant failure, angled abutments

Outcome Measures

Primary Outcomes (1)

  • Implant failure

    clinical observation

    3 months interval

Study Arms (2)

Angled abutment

EXPERIMENTAL

According to the allocation, the experimental group will receive an angled abutment on the immediately placed implant. A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)

Other: Angled Abutment

Straight abutment

ACTIVE COMPARATOR

According to the allocation, the control group will receive on the immediately placed implant a Straight zero degree abutment . A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)

Other: straight abutment

Interventions

Angled AbutmentOTHER

virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated.

Angled abutment
straight abutmentOTHER

virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated.

Straight abutment

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with teeth or remaining roots indicated for extraction in the esthetic zone and eligible for immediate implant placement Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan Presence of adequate mesio distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast Presence of adjacent natural teeth to the tooth/teeth to be extracted

You may not qualify if:

  • Presence of active signs or symptoms of acute infection in the tooth or the remaining root Heavy smokers (more than 2 packs per day) Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation) Severe overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Giza, Egypt

Location

Related Publications (1)

  • Araújo, M.G. et al., 2005. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. Journal of clinical periodontology, 32(6), pp.645-52. Brosh, T., Pilo, R. & Sudai, D., 1998. The influence of abutment angulation on strains and stresses along the implant/bone interface: comparison between two experimental techniques. The Journal of prosthetic dentistry, 79(3), pp.328-34. Chrcanovic, B.R., Albrektsson, T. & Wennerberg, A., 2015. Tilted versus axially placed dental implants: a meta-analysis. Journal of dentistry, 43(2), pp.149-70. Del Fabbro, M. et al., 2015. Immediate loading of postextraction implants in the esthetic area: systematic review of the literature. Clinical implant dentistry and related research, 17(1), pp.52-70.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
due to the nature of the study only the participant could be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer Prosthodontic department Faculty of Dentistry

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 9, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)