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

University of Santiago de Compostela

Status

Enrolling

Conditions

Tooth Extraction

Tooth Absence

Dental Implant

Treatments

Radiation: Low Laser Radiation off

Radiation: Low Laser Radiation

Other: Changing the implant surface

Procedure: Installing the dental crown with early loading

Procedure: Implant placement immediately after tooth extraction

Study type

Interventional

Funder types

Other

Identifiers

NCT05106855

RCT-NEO-PBM-21

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups

Implants GM Acqua surface, with LLLT.

Other group

Description:

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).

Treatment:

Procedure: Implant placement immediately after tooth extraction

Procedure: Installing the dental crown with early loading

Radiation: Low Laser Radiation

Implants GM Acqua surface, without LLLT.

Other group

Description:

Treatment:

Procedure: Implant placement immediately after tooth extraction

Procedure: Installing the dental crown with early loading

Radiation: Low Laser Radiation off

Implants GM NeoPoros surface, with LLLT.

Other group

Description:

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).

Treatment:

Procedure: Implant placement immediately after tooth extraction

Procedure: Installing the dental crown with early loading

Other: Changing the implant surface

Radiation: Low Laser Radiation

Implants NeoPoros surface, without LLLT.

Other group

Description:

Treatment:

Procedure: Implant placement immediately after tooth extraction

Procedure: Installing the dental crown with early loading

Other: Changing the implant surface