NCT03741036

Brief Summary

compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone 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 Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 19, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2019

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

October 19, 2018

Last Update Submit

November 16, 2018

Conditions

Keywords

immidiatedental implantimmidiate provisionalizationbone graft

Outcome Measures

Primary Outcomes (1)

  • Primary stability (marginal bone loss)

    measure device (osstell )

    3 months

Study Arms (3)

autogenous bone graft as a space filling material

ACTIVE COMPARATOR

Autogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket

Procedure: Autogenous bone graft as space filling in immidiate implant placment

deproteinized bovine as a space filling material

ACTIVE COMPARATOR

Granules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was \> 3 mm.

Procedure: Deprotinized bovien as space filling in immidate implant placement

nano-hydroxyapatite alloplast as a space filling material

ACTIVE COMPARATOR

The patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket

Procedure: Nano-hydroxiapatite alloplast in immidiate implant placement

Interventions

* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues

autogenous bone graft as a space filling material

* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues

deproteinized bovine as a space filling material

* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material ) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues

nano-hydroxyapatite alloplast as a space filling material

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placemen

You may not qualify if:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Egypt

Location

Mohamed tarek

Cairo, Egypt

Location

Central Study Contacts

mohamed tarek, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 19, 2018

First Posted

November 14, 2018

Study Start

November 27, 2018

Primary Completion

July 27, 2019

Study Completion

August 17, 2019

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations