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

NCT04346706 | Completed

• 1 other identifier: FMD124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction; Dental Implantation; Bone Remodeling

Keywords

Dental implantation; Immediate dental implant loading; Marginal bone remodeling

Outcome Measures

Primary Outcomes (2)

• Change from baseline of marginal vertical bone level at 6 months

  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

  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 Outcomes (2)

• Change from baseline of implant stability quotient at 3 months

  Following procedure at day 0 (implant insertion) and 3 months (post-implantation)

• Record of insertion torque

  Following procedure at day 0 (implant insertion)

Study Arms (2)

Immediate implantation

EXPERIMENTAL

Tooth extraction, immediate insertion of an implant with immediate temporization

Device: Extraction and Implant insertion (test)

Delayed implantation

EXPERIMENTAL

Implant inserted in a healed socket with immediate temporization

Device: Implant insertion (control)

Interventions

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.

Immediate implantation

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.

Delayed implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University

Beirut, 1104 2020, Lebanon

Location

Related Publications (38)

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Study Officials

• Nada Naaman, PhD

  Saint-Joseph University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiographic measurements were done by a different clinician than the surgeon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: February 10, 2018
• Primary Completion: July 20, 2019
• Study Completion: November 25, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication for 10 years
• Access Criteria: The complete dataset can be available for researchers working on a meta-analysis

Locations

LE (1)