Non-invasive Solution for Periodontal and Peri-implant Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Implant performance verification: implant survival rate. Change will be assessed.
研究概览
简要总结
DESCRIPTION: The Investigational Product "A-Ce toughened TZP nanocomposite implant" is a Medical Device (MD) intended for the dental rehabilitation of edentulous sites with fixed prosthesis. The "G3®-coated NK2® abutment" is a MD intended for the prevention of peri-implant bone loss due to peri-implantitis. The MD are for dental use and will be used exclusively on subjects who have signed an informed consent form and by approved study investigators.
OBJECTIVES: (a) To evaluate the safety and performance of the "A-Ce toughened TZP nanocomposite Implant" for its intended medical application purpose in the context of successful osseointegration of zirconia-based dental implants. (b) To evaluate the safety and performance of the "G3®-coated NK2® abutment" for its intended purpose in the context of peri-implantitis prevention. (c) To obtain the regulatory CE Mark Certification status for both medical devices.
TYPE OF INVESTIGATION: Randomized double-blind (patient, appraiser) controlled study.
CENTER/COUNTRY: Instituto de Cirugía Oral Avanzada (ICOA), Madrid, Spain
GROUPS:
Group A: 30 zirconia implants with 30 G3-coated abutments (test implant and abutment) Group B: 30 test implants with 30 uncoated (control) abutments Group C: 30 Ti implants (control) with 30 test abutments Group D: 30 control implants with 30 control abutments Group E: 3 test implants and 3 control implants, for histological/histomorphometric evaluation.
COMPARATIVE DEVICE: Commercial Ti dental implant.
STATISTICAL METHODOLOGY:
H0 : INPERIO performs worse (with statistical significance) than the commercial devices.
- Test implants achieve a higher failure rate than Ti implants.
- The clinical osseointegration parameter values are worse with statistical significance for test implants than for control implants.
- Histological and histomorphometric analysis shows worse quality and quantity of osseointegration for test implants than for Ti implants.
H1: There is no statistical significance between INPERIO and the commercial solution or INPERIO performs better (with statistical significance) than the commercial Ti implants.
- Test implants achieve the same failure rate or less than Ti implants.
- The clinical osseointegration parameter values are no different or are better with statistical significance for test implants than for control implants.
- The histological and histomorphometric analysis shows a similar or better quality and quantity of osseointegration for test implants than for Ti implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females of age 18-
- •Availability for the 18 months duration of the clinical trial.
- •Subject able and willing to follow study procedures and instructions.
- •Subject read, understood and signed an informed consent form.
- •Participants in need of dental implant treatment and that meet one of the following criteria:
- •Moderate to advanced periodontitis.
- •History of dental loss attributed to periodontitis.
- •Risk factors associated with periodontitis (tobacco consumption, poor oral hygiene, diabetes patients outside of the ideal range control (HbA1c <7)).
- •Good general health at time of inclusion.
- •Subjects willing to disclose information on medication.
排除标准
- •Female patients who report being pregnant or lactating, or who are of childbearing potential and are not using hormonal, barrier methods of birth control or abstinence.
- •Subject chronically treated (≥ two weeks) with any medication known to affect inflammation or periodontal status six months prior to enrollment or during the study.
- •Subject necessitating antibiotic for 1 month during the study.
- •Gross oral pathology.
- •Participation in any other clinical study or test panel within one month prior to entry into the study.
- •History of neoplastic disease requiring the use of chemotherapy.
- •Patients with history of renal failure or chronic renal diseases.
- •Patients affected by chronic liver diseases.
- •Patients with severe or uncontrolled metabolic bone disorders.
- •Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for undergoing surgery, or could prevent study completion or interfere with the analysis of the results, such as a history of non-compliance or unreliability.
- •History of local radiation therapy.
结局指标
主要结局
Implant performance verification: implant survival rate. Change will be assessed.
时间窗: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Number of functional implants vs. number of implants inserted.
Implant performance verification: osseointegration (ex vivo).
时间窗: 2 months after implantation.
Please refer to Arms and Interventions, Experimental: Group E. For ethical reasons, this sample size is limited to six (6) implants, 3 test and 3 controls. Trephined blocks containing the explanted implants will be stored in a 5% formaldehyde solution (pH 7). They will be immersed in a 4% formaldehyde and 1% calcium solution and processed for ground sectioning following the Donath \& Breuner methods. Each implant block will be individualized, embedded in methyl-methacrylate and stained with combined Harris Haematoxyline and Wheatley. The analysis will be performed using a transmitted light microscope equipped with a digital camera. Results will be inferred to clinical osseointegration data, which is the way to assess osseointegration in everyday chairside practice.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
时间窗: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Osseointegration quality: implant stability will be assessed via metal instrument tapping - the transmitted sound will indicate good/bad osseointegration.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
时间窗: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Assessment of peri-implant inflammation sign: bleeding on probing (BOP).
次要结局
- Prosthetic complications. Change will be assessed.(Day 1 (abutment connection), 3 months, 6 months, 1 year.)