NCT03665025

Brief Summary

Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap

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
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

September 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

September 6, 2018

Last Update Submit

September 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Crestal bone loss

    Will be measured using calliper with scale(1-10mm) for evaluation of crestal bone loss around implant which are the lower values represent a better outcome.

    1 year

Secondary Outcomes (1)

  • Patient satisfaction

    1 year

Study Arms (2)

immediate implant placement with xenograft

EXPERIMENTAL

Immediate implant placement with the use of xenograft as grafting material

Other: immediate implant using mixed allograft and xenograft

immediate implant using mixed allograft and xenograft

EXPERIMENTAL

Immediate implant placement with using mixture of allograft and xenograft material

Other: immediate implant using mixed allograft and xenograft

Interventions

immediate implant using mixed allograft and xenograft in anterior area to fill jumping area

immediate implant placement with xenograftimmediate implant using mixed allograft and xenograft

Eligibility Criteria

Age20 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, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.

You may not qualify if:

  • Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
  • Heavy smokers more than 20 cigarettes per day .(24)
  • 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, or bone augmentation to implant site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed

Kuwait City, Q8, 00965, Kuwait

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Central Study Contacts

mohamed hammad, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: jumping gap area in aesthetic area
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of oral and maxillofacial surgery-Cairo university

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 11, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations