Clinical Efficacy of the Immediate Implant Loading

July 27, 2018 updated by: Damascus University

Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone

Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).

Materials and methods:

20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools.

Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).

Materials and methods:

20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.

The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study.

Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Department of Oral Implantology -Sante Jousef University - School of Dental Medicine
  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Fixed Prosthodontics, University of Damsacus
      • Damascus, Syrian Arab Republic
        • Nano Physical lab and biomaterial Lab - College of Applied Sciences

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. esthetic request.
  2. either incisor or canine indicated for extraction.
  3. symmetrical gingival level.
  4. no active periodontal disease.
  5. age between 20-40 years old

Exclusion Criteria:

  1. Lateral hopeless tooth .
  2. Active periodontal lesion .
  3. loss of periodontal tissue .
  4. missed incisor or missed canine in the area of implantation.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct provisional technique
Patients here will be subjected to the direct provisional technique
Procedure: Direct provisional technique
The method of implantation will be accomplished directly.
Active Comparator: Indirect Provisional technique
Patients here will be subjected to the indirect provisional technique
Procedure: Indirect Provisional technique
The method of implantation will be accomplished indirectly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alveolar bone level
Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using cone-beam computed tomography images
T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in the Gingival Index
Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the the gingival index
T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in Esthetic Appearance
Time Frame: T1: at one day before implantation, T2: at three months following implantation
This will be measured by using the White Esthetic Scale (WES)
T1: at one day before implantation, T2: at three months following implantation
Change in the Plaque Index
Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the the plaque index
T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Change in the Pink Esthetic Scale
Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using the Pink Esthetic Scale
T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Restoration Color
Time Frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
This will be measured using a standardized color guide
T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

Collaborators and Investigators

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

Sponsor

Damascus University

Collaborators

St Joseph University, Beirut, Lebanon
Syrian Atomic Energy Agency, Damascus, Syria

Investigators

  • Principal Investigator: Anas Abdo, DDS MSc, PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School
  • Study Director: Osama Yousuf Solieman, DDS MSc PhD, Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France
  • Study Director: Christian Makary, DDS MSc PhD, Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon
  • Study Chair: Mirza Allaf, DDS MSc PhD, Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 19, 2017

Primary Completion (Actual)

January 19, 2018

Study Completion (Actual)

July 19, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UDDS-FixPro-01-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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