NCT03397316

Brief Summary

Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side. the study is to assess the marginal bone loss in the two techniques and compare results between them.

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
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

January 1, 2018

Last Update Submit

January 13, 2018

Conditions

Bone Loss

Keywords

immediate implantupper esthetic zonemarginal bone loss

Outcome Measures

Primary Outcomes (1)

  • marginal bone loss

    Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft

    4 months

Secondary Outcomes (1)

  • patient satisfaction

    4 months

Study Arms (2)

Marginal bone loss without grafting.

NO INTERVENTION

immediate implant placement in upper esthetic zone.

marginal bone loss with xenograft.

ACTIVE COMPARATOR

xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface.

Procedure: xenograft placement .

Interventions

xenograft placement .PROCEDURE

immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface.

marginal bone loss with xenograft.

Eligibility Criteria

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

You may qualify if:

  • Adult patients with badly broken teeth in upper esthetic zone indicated for extraction presence of at least 4 mm of bone beyond root apex

You may not qualify if:

  • presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases that may affect normal healing. psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each patient will be given a code by researcher (A.A) and the observers will be blind to which group this case belong.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 12, 2018

Study Start

July 1, 2017

Primary Completion

March 15, 2018

Study Completion

April 1, 2018

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

EG(1)