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

Sponsor
Saint-Joseph University (Other)
Overall Status
Completed
CT.gov ID
NCT04346706
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
21.5
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extraction and Implant insertion (test)
  • Device: Implant insertion (control)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The radiographic measurements were done by a different clinician than the surgeon
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Feb 10, 2018
Actual Primary Completion Date :
Jul 20, 2019
Actual Study Completion Date :
Nov 25, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline of marginal vertical bone level at 6 months [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

  2. Change from baseline of bone plate thickness at 6 months [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

Secondary Outcome Measures

  1. Change from baseline of implant stability quotient at 3 months [Following procedure at day 0 (implant insertion) and 3 months (post-implantation)]

    Measurements of implant stability quotient (ISQ) following implant insertion

  2. Record of insertion torque [Following procedure at day 0 (implant insertion)]

    Insertion torque value at implant placement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint-Joseph University Beirut Lebanon 1104 2020

Sponsors and Collaborators

  • Saint-Joseph University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nada BOU ABBOUD NAAMAN, Principal investigator, Saint-Joseph University
ClinicalTrials.gov Identifier:
NCT04346706
Other Study ID Numbers:
  • FMD124
First Posted:
Apr 15, 2020
Last Update Posted:
Apr 15, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nada BOU ABBOUD NAAMAN, Principal investigator, Saint-Joseph University
Dental implantation
Immediate dental implant loading
Marginal bone remodeling

Study Results

No Results Posted as of Apr 15, 2020