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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients satisfying all inclusion criteria and none of the
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Low Laser Radiation (Radiation)
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).
干预措施: Implant placement immediately after tooth extraction (Procedure)
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).
干预措施: Installing the dental crown with early loading (Procedure)
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.
干预措施: Low Laser Radiation off (Radiation)
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.
干预措施: Implant placement immediately after tooth extraction (Procedure)
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.
干预措施: Installing the dental crown with early loading (Procedure)
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).
干预措施: Low Laser Radiation (Radiation)
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).
干预措施: Changing the implant surface (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).
干预措施: Implant placement immediately after tooth extraction (Procedure)
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).
干预措施: Installing the dental crown with early loading (Procedure)
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.
干预措施: Changing the implant surface (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.
干预措施: Low Laser Radiation off (Radiation)
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.
干预措施: Implant placement immediately after tooth extraction (Procedure)
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.
干预措施: Installing the dental crown with early loading (Procedure)
结局指标
主要结局
Implant stability
时间窗: 3 months
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Implant survival rate
时间窗: 3 months
After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.
Marginal bone loss
时间窗: 3 months
Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.
次要结局
- Implant failure(3 months)
研究者
Mario Pérez Sayáns
Professor
University of Santiago de Compostela