Clinical trial NCT05106855: Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Tooth Absence
Tooth Extraction
Keywords: immediate implant
post-extraction implant
early loading
photobiomodulation
oral rehabilitation
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Implant survival rate
timeFrame: 3 months
measure: Implant stability
timeFrame: 3 months
measure: Marginal bone loss
timeFrame: 3 months
Secondary outcomes:
measure: Implant failure
timeFrame: 3 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Universidad de Santiago de Compostela
state: A Coruña
Study officials:
References: