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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05106855
Enrollment
60
Registered
2021-11-04
Start date
2022-03-03
Completion date
2024-12-20
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Tooth Absence, Tooth Extraction

Keywords

immediate implant, post-extraction implant, early loading, photobiomodulation, oral rehabilitation

Brief 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. 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.

Interventions

RADIATIONLow Laser Radiation

One group will receive laser application to check if there is acceleration of healing.

OTHERChanging the implant surface

Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.

RADIATIONLow Laser Radiation off

This group will receive laser application off.

PROCEDUREImplant 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.

PROCEDUREInstalling 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.

Sponsors

University of Santiago de Compostela
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Implant survival rate3 monthsAfter comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.
Implant stability3 monthsBasal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Marginal bone loss3 monthsMeasured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.

Secondary

MeasureTime frameDescription
Implant failure3 monthsTo 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026