Immediate Implant With Provisionalization

March 6, 2022 updated by: Dalya Munther Naeem, University of Baghdad

Primary Versus Secondary Implant Stability in Relation to Gap Distance of Immediate Implant With Immediate Loading by Provisional Restoration

Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Bab Al Moatham
      • Baghdad, Bab Al Moatham, Iraq, 11001
        • Recruiting
        • College of Dentistry
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adult with non restorable dental unit seeking for immediate implantation with provisionalization

Description

Inclusion Criteria:

  1. Medical and psychological fitness for minor oral surgery.
  2. Age 20-60 years.
  3. medium to thick gingival biotype.
  4. buccal plate thickness more than (1mm).

Exclusion Criteria:

  1. Smoking habit.
  2. Diabetes mellitus.
  3. A systemic disorder that is contraindicated for the minor surgical procedure.
  4. Pregnancy or lactation.
  5. Any irradiation in head and neck area.
  6. Need for bone augmentation procedure.
  7. Clinical signs of bruxism or other severe functional disorders.
  8. patient with periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with non restorable teeth
Patient with non restorable teeth located in smile line needs extraction with immediate implantation and immediate provisionalization to improve psychiatric effect of tooth loss
Procedure: Tooth guided immediate implant placement
The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the single rooted teeth to be extracted as a reference and as aid for apical engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant primary stability
Time Frame: 0 day
The stability measured by resonance frequancy analysis device (osstell)
0 day
Jumping gab
Time Frame: 0 day
The gab that located between the implant surface and buccal plate
0 day
Pink esthetic score
Time Frame: 0 day, before extraction and implant placement
Denote the esthetic profile of bone and gingiva
0 day, before extraction and implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant secondary stability
Time Frame: Up to 16 weeks
The stability measured by resonance frequancy analysis device (osstell)
Up to 16 weeks
Ridge reduction
Time Frame: Up to 16 weeks
The amount of reduction in buccal profile of the alveolar ridge
Up to 16 weeks
Pink esthetic score
Time Frame: after implantation By 4 months
Denote the esthetic profile of bone and gingiva
after implantation By 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

November 27, 2021

Study Completion (Anticipated)

March 27, 2022

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1427705

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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