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

NCT05106855 | Completed

• 1 other identifier: RCT-NEO-PBM-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Tooth Absence; Tooth Extraction

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Implant failure

  3 months

Study Arms (4)

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).

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.

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).

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.

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

Interventions

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.

Implants GM Acqua surface, with LLLT.; Implants GM Acqua surface, without LLLT.; Implants GM NeoPoros surface, with LLLT.; Implants NeoPoros surface, without LLLT.

Low Laser Radiation RADIATION

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

Implants GM Acqua surface, with LLLT.; Implants GM NeoPoros surface, with LLLT.

Changing the implant surface OTHER

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

Implants GM NeoPoros surface, with LLLT.; Implants NeoPoros surface, without LLLT.

Low Laser Radiation off RADIATION

This group will receive laser application off.

Implants GM Acqua surface, without LLLT.; Implants NeoPoros surface, without LLLT.

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.

Implants GM Acqua surface, with LLLT.; Implants GM Acqua surface, without LLLT.; Implants GM NeoPoros surface, with LLLT.; Implants NeoPoros surface, without LLLT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 4, 2021
• Study Start: March 3, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 20, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

ES (1)