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Completed

NCT Number: NCT05106855

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

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.

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Key information

Conditions

Dental Implant Tooth Absence Tooth Extraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Laser Radiation

Radiation

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

Changing the implant surface

Other

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

Low Laser Radiation off

Radiation

This group will receive laser application off.

Implant placement immediately after tooth extraction

Procedure

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

Procedure

The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.

Primary outcomes

  1. Implant survival rate

    Time frame: 3 months

    After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.

  2. Implant stability

    Time frame: 3 months

    Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).

  3. Marginal bone loss

    Time frame: 3 months

    Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.

Secondary outcomes

  1. Implant failure

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2021
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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