Dental ImplantNCT05106855
Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.
A study testing Low Laser Radiation, Changing the implant surface and Low Laser Radiation off in people with Dental Implant and Tooth Absence, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Tooth Absence, Tooth Extraction
- What is being tested?
- Low Laser Radiation, Changing the implant surface and Low Laser Radiation off
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785
About this study
Official title: 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.
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.
- Conditions
- Dental Implant, Tooth Absence, Tooth Extraction
- Being tested
- Low Laser Radiation, Changing the implant surface, Low Laser Radiation off, Implant placement immediately after tooth extraction, Installing the dental crown with early loading
- Keywords
- immediate implant, post-extraction implant, early loading, photobiomodulation, oral rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Laser RadiationRadiation
One group will receive laser application to check if there is acceleration of healing.
Changing the implant surfaceOther
Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.
Low Laser Radiation offRadiation
This group will receive laser application off.
Implant placement immediately after tooth extractionProcedure or surgery
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 loadingProcedure or surgery
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.
| Study group | Role | What they receive |
|---|---|---|
| Implants GM Acqua surface, with LLLT. | Other | 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). Receives: Radiation: Low Laser Radiation; Procedure: Implant placement immediately after tooth extraction; Procedure: Installing the dental crown with early loading |
| Implants GM Acqua surface, without LLLT. | Other | 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. Receives: Radiation: Low Laser Radiation off; Procedure: Implant placement immediately after tooth extraction; Procedure: Installing the dental crown with early loading |
| Implants GM NeoPoros surface, with LLLT. | Other | 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). Receives: Radiation: Low Laser Radiation; Other: Changing the implant surface; Procedure: Implant placement immediately after tooth extraction; Procedure: Installing the dental crown with early loading |
| Implants NeoPoros surface, without LLLT. | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.
Measured: 3 months
Implant stability
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Measured: 3 months
Marginal bone loss
Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start3 Mar 2022
- Primary completion30 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106855
- Sponsor's protocol ID
- RCT-NEO-PBM-21
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2021
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05106855
- Acronym / sponsor ID
- RCT-NEO-PBM-21
- Conditions
- Dental Implant, Tooth Absence, Tooth Extraction
- Keywords
- immediate implant, post-extraction implant, early loading, photobiomodulation, oral rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Implants GM Acqua surface, with LLLT. | Other | Radiation: Low Laser Radiation, Procedure: Implant placement immediately after tooth extraction, Procedure: Installing the dental crown with early loadingSurgical 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). |
| Implants GM Acqua surface, without LLLT. | Other | Radiation: Low Laser Radiation off, Procedure: Implant placement immediately after tooth extraction, Procedure: Installing the dental crown with early loadingSurgical 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. |
| Implants GM NeoPoros surface, with LLLT. | Other | Radiation: Low Laser Radiation, Other: Changing the implant surface, Procedure: Implant placement immediately after tooth extraction, Procedure: Installing the dental crown with early loadingSurgical 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). |
| Implants NeoPoros surface, without LLLT. | Other | Other: Changing the implant surface, Radiation: Low Laser Radiation off, Procedure: Implant placement immediately after tooth extraction, Procedure: Installing the dental crown with early loadingSurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Laser RadiationOne group will receive laser application to check if there is acceleration of healing. | Radiation | Implants GM Acqua surface, with LLLT., Implants GM NeoPoros surface, with LLLT. |
| Changing the implant surfaceChanging the treatment surface of the dental implant to see if osseointegration occurs more quickly. | Other | Implants GM NeoPoros surface, with LLLT., Implants NeoPoros surface, without LLLT. |
| Low Laser Radiation offThis group will receive laser application off. | Radiation | Implants GM Acqua surface, without LLLT., Implants NeoPoros surface, without LLLT. |
| Implant placement immediately after tooth extractionWhen the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed. | Procedure or surgery | Implants GM Acqua surface, with LLLT., Implants GM Acqua surface, without LLLT., Implants GM NeoPoros surface, with LLLT., Implants NeoPoros surface, without LLLT. |
| Installing the dental crown with early loadingThe installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed. | Procedure or surgery | Implants GM Acqua surface, with LLLT., Implants GM Acqua surface, without LLLT., Implants GM NeoPoros surface, with LLLT., Implants NeoPoros surface, without LLLT. |
Primary outcome
Implant survival rate
Time frame: 3 months
After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.
Implant stability
Time frame: 3 months
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Marginal bone loss
Time frame: 3 months
Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.
1 secondary outcome
Implant failure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided. We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Laser Radiation, Changing the implant surface and Low Laser Radiation off in people with Dental Implant and Tooth Absence, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.