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.

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 Overview

• Status: Recruiting
• Conditions: Dental Implant; Tooth Extraction; Tooth Absence
• Intervention / Treatment: Radiation: Low Laser Radiation; Procedure: Implant placement immediately after tooth extraction; Procedure: Installing the dental crown with early loading; Radiation: Low Laser Radiation off; Other: Changing the implant surface

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gisela Cristina Vianna Camolesi, PhD student; Phone Number: 663482098; Email: gicamolesi@gmail.com
• Study Contact Backup: Name: Mario Pérez-Sayáns, PhD; Phone Number: 0034626233504; Email: mario.perez@usc.es

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15785
      • Recruiting
      • Universidad de Santiago de Compostela
      • Contact: Mario Pérez Sayáns, PhD; Phone Number: 0034626233504; Email: mario.perez@usc.es
      • Contact: Mario Pérez Sayáns, PhD; Email: mario.perez@usc.es
      • Principal Investigator: Mario Perez Sayans, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implants GM Acqua surface, with LLLT.; 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; One group will receive laser application to check if there is acceleration of healing.; Procedure: Implant 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.; Procedure: Installing 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.
Other: Implants GM Acqua surface, without LLLT.; 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.	Procedure: Implant 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.; Procedure: Installing 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.; Radiation: Low Laser Radiation off; This group will receive laser application off.
Other: Implants GM NeoPoros surface, with LLLT.; 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; One group will receive laser application to check if there is acceleration of healing.; Procedure: Implant 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.; Procedure: Installing 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.; Other: Changing the implant surface; Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.
Other: Implants NeoPoros surface, without LLLT.; 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.	Procedure: Implant 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.; Procedure: Installing 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.; Radiation: Low Laser Radiation off; This group will receive laser application off.; Other: Changing the implant surface; Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): May 20, 2024

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: photobiomodulation; immediate implant; early loading; oral rehabilitation; post-extraction implant
• Other Study ID Numbers: RCT-NEO-PBM-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No