Immediate Implant Placement in Fresh Extraction Sockets and Delayed Implants in Healed Sockets.

April 11, 2020 updated by: Nada BOU ABBOUD NAAMAN, Saint-Joseph University

Radiographic Evaluation of Marginal Bone Level, Buccal and Palatal Plate Thickness Alteration, and Implant Stability After Placement in Healed Ridges and Fresh Extraction Sockets: A 6 Months Prospective Study.

The purpose of this prospective clinical study was to compare in delayed and immediately placed implants, the marginal vertical bone loss at 4 sides of the implant (buccal, palatal, mesial and distal), as well as the buccal and palatal bone thickness reduction at 3 months after loading.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty-four patients were consecutively selected and enrolled in this study based on the aforementioned exclusion and inclusion criteria. Clinical examination was done by a different clinician than the operator, and according to the treatment indication, patients were allocated to the delayed implant placement group (Control), or the immediate implant placement group (Test). Thus, 15 implants were placed in healed extraction sites and immediately temporized (Control group), and 15 implants were placed in immediate extraction sites with immediate temporization (Test group).

Provisional acrylic crowns were prepared. All patients were placed on a prophylactic antibiotic regimen, starting one day prior to surgery as they were asked to take amoxicillin 500 mg; three times a day for 10 days or clindamycin 300 mg twice daily for 10 days for penicillin-allergic patients.

For the test group, tooth extractions were carried out atraumatically using periotomes. In both groups, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm.

Temporary abutments were connected to the implants and torqued at 20 Ncm, and then temporary crowns were cemented on top of the abutments after checking and reducing occlusion to non-existent in both centric and lateral excursions.

Study Type

Interventional

Enrollment (Actual)

24

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, 1104 2020
        • Saint-Joseph University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over 18 years old, compliant (willing to show up to all their follow-up visits), and able to read, understand and sign an informed consent. All patients were to have good oral hygiene levels (full mouth plaque scores (FMPS) <15-20%, and full mouth bleeding index (FMBI) <15-20%), requiring implant insertion in a maxillary premolar site either immediately or in a healed "pristine bone".

Exclusion Criteria:

  • Presence of major contraindications to implant surgery, patients that had received head and neck radiation for cancer treatment, immunosuppressed or immunocompromised patients, uncontrolled diabetes, pregnant or breast-feeding woman, untreated periodontitis and/or poor oral hygiene and motivation, presence of buccal dehiscence, and finally previous bone grafting or ridge preservation in the studied area.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate implantation
Tooth extraction, immediate insertion of an implant with immediate temporization
Device: Extraction and Implant insertion (test)

The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated. Tooth extractions were carried out atraumatically using periotomes. Implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ, at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.

Absorbable interrupted 4.0 sutures were used for flap closure.
Experimental: Delayed implantation
Implant inserted in a healed socket with immediate temporization
Device: Implant insertion (control)

The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ. This was done at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.

Absorbable interrupted 4.0 sutures were used for flap closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of marginal vertical bone level at 6 months
Time Frame: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Marginal vertical bone level changes at 4 sides of the implant (buccal, palatal, mesial and distal) on Cone Beam Computed Tomography (CBCT) images
Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Change from baseline of bone plate thickness at 6 months
Time Frame: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Buccal and palatal bone thickness at 4 levels : 0 mm, 2 mm, 4 mm and 6 mm from the implant platform on CBCT images
Following procedure at day 0 (implant insertion) and 6 months (post-implantation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of implant stability quotient at 3 months
Time Frame: Following procedure at day 0 (implant insertion) and 3 months (post-implantation)
Measurements of implant stability quotient (ISQ) following implant insertion
Following procedure at day 0 (implant insertion) and 3 months (post-implantation)
Record of insertion torque
Time Frame: Following procedure at day 0 (implant insertion)
Insertion torque value at implant placement
Following procedure at day 0 (implant insertion)

Collaborators and Investigators

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

Sponsor

Saint-Joseph University

Investigators

  • Study Director: Nada Naaman, PhD, Saint-Joseph University

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)

February 10, 2018

Primary Completion (Actual)

July 20, 2019

Study Completion (Actual)

November 25, 2019

Study Registration Dates

First Submitted

April 11, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 11, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMD124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient characteristics. Outcome measures

IPD Sharing Time Frame

6 months after publication for 10 years

IPD Sharing Access Criteria

The complete dataset can be available for researchers working on a meta-analysis

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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