Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.
NCT ID: NCT05106855
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-03-03
2024-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Implants GM Acqua surface, with LLLT.
Surgical protocol Periotomes will be used for atraumatic extraction and/or a stainless steel tooth extractor.
The implant, GM Acqua, will be placed in a flapless manner through the alveolus, manually or mechanically, and a minimum length of 2 mm longer than the root length. The implant placement site will be prepared following the manufacturer's protocol.
The minimum torque that to be employed to attain primary stability of the implant will have to be ≥ 30 Ncm measured with a manual torque wrench. (Neodent®).
After the implant has been placed, a healing abutment GM (Neodent®) will be placed, with a maximum torque of 10 N.cm.
LLLT protocol:
With a infrared diode laser, wavelength of 808 nm, continuous mode, a dose of 2J per spot, for 20 seconds per spot, the following irradiation protocol shall be applied: immediately after surgery and on days 3 and 7 after surgery, 4 spots (2 in the vestibular and 2 in lingual/palatal of the alveolus/implant).
Low Laser Radiation
One group will receive laser application to check if there is acceleration of healing.
Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
Implants GM Acqua surface, without LLLT.
Surgical protocol Periotomes will be used for atraumatic extraction and/or a stainless steel tooth extractor.
The implant, GM Acqua, will be placed in a flapless manner through the alveolus, manually or mechanically, and a minimum length of 2 mm longer than the root length. The implant placement site will be prepared following the manufacturer's protocol.
The minimum torque that to be employed to attain primary stability of the implant will have to be ≥ 30 Ncm measured with a manual torque wrench. (Neodent®).
After the implant has been placed, a healing abutment GM (Neodent®) will be placed, with a maximum torque of 10 N.cm.
Low Laser Radiation off
This group will receive laser application off.
Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
Implants GM NeoPoros surface, with LLLT.
Surgical protocol Periotomes will be used for atraumatic extraction and/or a stainless steel tooth extractor.
The implant, GM NeoPoros, will be placed in a flapless manner through the alveolus, manually or mechanically, and a minimum length of 2 mm longer than the root length. The implant placement site will be prepared following the manufacturer's protocol.
The minimum torque that to be employed to attain primary stability of the implant will have to be ≥ 30 Ncm measured with a manual torque wrench. (Neodent®).
After the implant has been placed, a healing abutment GM (Neodent®) will be placed, with a maximum torque of 10 N.cm.
LLLT protocol:
With a infrared diode laser, wavelength of 808 nm, continuous mode, a dose of 2J per spot, for 20 seconds per spot, the following irradiation protocol shall be applied: immediately after surgery and on days 3 and 7 after surgery, 4 spots (2 in the vestibular and 2 in lingual/palatal of the alveolus/implant).
Low Laser Radiation
One group will receive laser application to check if there is acceleration of healing.
Changing the implant surface
Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.
Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
Implants NeoPoros surface, without LLLT.
Surgical protocol Periotomes will be used for atraumatic extraction and/or a stainless steel tooth extractor.
The implant, GM NeoPoros, will be placed in a flapless manner through the alveolus, manually or mechanically, and a minimum length of 2 mm longer than the root length. The implant placement site will be prepared following the manufacturer's protocol.
The minimum torque that to be employed to attain primary stability of the implant will have to be ≥ 30 Ncm measured with a manual torque wrench. (Neodent®).
After the implant has been placed, a healing abutment GM (Neodent®) will be placed, with a maximum torque of 10 N.cm.
Changing the implant surface
Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.
Low Laser Radiation off
This group will receive laser application off.
Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
Interventions
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Low Laser Radiation
One group will receive laser application to check if there is acceleration of healing.
Changing the implant surface
Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.
Low Laser Radiation off
This group will receive laser application off.
Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
Eligibility Criteria
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Inclusion Criteria
* Patients without systemic pathology or medical and general contraindications that are absolute contraindications for surgical procedures;
* Adults who agree to take part in the study and signed the informed consent form.
* Smokers of less than 5 cigarettes/day.
* Not to be completely edentulous.
* Need for extraction of at least one tooth.
* Post-extraction bone area (fresh alveolus).
* Patients with sufficient bone height to obtain primary stability for implant installation (2 mm longer than the largest root).
* Edentulous areas with sufficient mesial-distal, buccolingual and interocclusal space for the placement of an anatomical restoration with a prosthetic space of at least 5 mm.
Exclusion Criteria
* Smokers of more than 5 cigarettes/day.
* Bleeding rate greater than 30 %.
* Presence of active or uncontrolled periodontal disease;
* Patients with less than 2 mm of keratinised gingiva.
* Implants with primary stability with ISQ \< 50
* When this is not possible, assume a security margin to the inferior dental nerve of at least 1 mm.
* Previus history of local radiotherapy in the head and neck region.
18 Years
ALL
Yes
Sponsors
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University of Santiago de Compostela
OTHER
Responsible Party
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Mario Pérez Sayáns
Professor
Locations
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Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Countries
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Other Identifiers
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RCT-NEO-PBM-21
Identifier Type: -
Identifier Source: org_study_id
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