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

Not Applicable

Recruiting

• Conditions: Dental Implant; Tooth Extraction; Tooth Absence

• Registration Number: NCT05106855
• Lead Sponsor: University of Santiago de Compostela

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-04
• Study Start: 2022-03-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-01
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Implant stability	3 months	Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Implant survival rate	3 months	After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.
Marginal bone loss	3 months	Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.

Secondary Outcome Measures

Name	Time	Method
Implant failure	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.

Trial Locations

Locations (1)

Universidad de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain