Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.

Study Overview
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Brief Summary
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Post-extraction implants are an alternative to traditional implant placement on completely healed bone, in order to reduce the number of surgical interventions, shorten treatment time, maintain bone architecture and thus provide better aesthetics. This study focuses on evaluating the results obtained by opting for different immediate placement of single dental implants protocols in a fresh alveolus, and its general objective is to compare implant stability and marginal bone loss (MBL) in implants installed post-extraction. For this, the investigators will placement Grand Morse Acqua or NeoPoros implants (Helix GM - Neodent, Curitiba, Brazil), in early loading protocols, with or without low level laser photobiomodulation (LLLT), in patients attending the Master of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela for oral rehabilitation using osseointegrated single dental implants in the maxillary and/or mandibular region.

Official Title
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Comparative Study of Immediate Single Unit Helix GM - Neodent Implants in Early Loading Protocols, With or Without Acqua Surface and With or Without Low Level Laser Photobiomodulation (LLLT). Single-blind Randomized Clinical Trial.

Conditions
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Dental Implant, Tooth Absence, Tooth Extraction

Intervention / Treatment
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* Radiation: Low Laser Radiation
* Other: Changing the implant surface
* Radiation: Low Laser Radiation off
* Procedure: Implant placement immediately after tooth extraction
* Procedure: Installing the dental crown with early loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients satisfying all inclusion criteria and none of the exclusion criteria will be informed verbally and in writing about the study and signed the informed consent form. The implant area is free of infection 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: Immunosuppressed. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implants GM Acqua surface, with LLLT.<br>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). | Radiation: Low Laser Radiation<br>* One group will receive laser application to check if there is acceleration of healing.<br>Procedure: Implant placement immediately after tooth extraction<br>* When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.<br>Procedure: Installing the dental crown with early loading<br>* The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.<br>|
| Other: Implants GM Acqua surface, without LLLT.<br>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. | Radiation: Low Laser Radiation off<br>* This group will receive laser application off.<br>Procedure: Implant placement immediately after tooth extraction<br>* When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.<br>Procedure: Installing the dental crown with early loading<br>* The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.<br>|
| Other: Implants GM NeoPoros surface, with LLLT.<br>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). | Radiation: Low Laser Radiation<br>* One group will receive laser application to check if there is acceleration of healing.<br>Other: Changing the implant surface<br>* Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.<br>Procedure: Implant placement immediately after tooth extraction<br>* When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.<br>Procedure: Installing the dental crown with early loading<br>* The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.<br>|
| Other: Implants NeoPoros surface, without LLLT.<br>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. | Other: Changing the implant surface<br>* Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.<br>Radiation: Low Laser Radiation off<br>* This group will receive laser application off.<br>Procedure: Implant placement immediately after tooth extraction<br>* When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.<br>Procedure: Installing the dental crown with early loading<br>* The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate | After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number. | 3 months | 
| Implant stability | Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ). | 3 months | 
| Marginal bone loss | Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant failure | To be assessed 3 months after surgery. Implant failure will be defined as implant failure when it is necessary to remove the implant due to implant mobility as a consequence of loss of osseointegration. Final total number. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immediate implant, post-extraction implant, early loading, photobiomodulation, oral rehabilitation