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OpenTrials
Completed

NCT Number: NCT04346706

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Joseph University

Beirut, 1104 2020, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extraction and Implant insertion (test)

Device

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.

Implant insertion (control)

Device

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Record of insertion torque

    Time frame: Following procedure at day 0 (implant insertion)

    Insertion torque value at implant placement

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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