One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures: a Factorial, Randomized Clinical Trial Testing the Outcomes of Immediate/Delayed Loading and Flapped/Flapless Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Implant survival and success
研究概览
简要总结
This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention.
The main study hypotheses are:
- There are significant improvements in PROMs following implant intervention compared to baseline measures;
- Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol.
- Flapless surgery has similar post-insertion outcomes compared to flapped surgery.
详细描述
This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention.
Main study hypotheses:
- There are significant improvements in PROMs following implant intervention compared to baseline measures;
- Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol;
- Flapless surgery has similar post-insertion outcomes compared to flapped surgery.
Statement of clinical relevance:
Mini implants are an alternative to standard implants for overdentures. They are suitable for insertion in narrow ridges, are less invasive, simpler, less costly, and faster to perform, and are especially advantageous for older and frail patients who would benefit from more conservative and less burdensome treatments. Although previous studies reported favorable outcomes regarding patient oral comfort and function, there is a need for implant/attachment systems with higher predictability on implant survival and retention performance in the long-term. This study aims to provide clinical evidence on the newly developed 2.4mm one-piece TiZr mini implant with a miniaturized carbon-based coating attachment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of longitudinal outcomes will be performed by an assessor blinded to the surgical/loading protocols
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No contraindications for implant surgery (mainly related to uncontrolled systemic diseases);
- •Enough bone height in the interforaminal area for an implant length of at least 10 mm;
- •Ability to understand and answer the questionnaires used in the study and agree to participate by providing a written informed consent.
排除标准
- •Noncompliant participants;
- •Disagreement to be randomly allocated to the treatment study groups;
- •Signs of untreated temporomandibular disorders or uncontrolled systemic or oral conditions that require additional treatments.
结局指标
主要结局
Implant survival and success
时间窗: Incidence thoughout the 12-month follow-up after implant placement.
Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.
Patient-perceived burdens
时间窗: Twenty-four hours after implant surgery.
The Burdens in Oral Surgery Questionnaire (BiOS-Q) will be used to assess patient-perceived burdens. It includes 16 items concerning all aspects of procedures occurring during a surgery. Responses for each item are assessed using a visual analogue scale (VAS) ranging from 0 = no expression of the attribute (e.g. not unpleasant at all) to 100 = maximum expression (e.g. very unpleasant).
Postoperative pain and discomfort
时间窗: Assessed 1 week after implant placement.
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Patient Satisfaction
时间窗: Assessed at the 12-month follow-up visit after implant placement.
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Surgical time
时间窗: Procedure (Assessed during the clinical visit of implant placement and overdenture delivery or denture adaptation.)
The time interval concerning the clinical visit for implant placement and delivery of the overdenture or denture adaptation will me measured and registered.
Consumption of analgesics
时间窗: Assessed until 1 week after implant placement.
The number of analgesics consumed by the participant during the post-operative and healing period will be recorded in the patient's file.
Oral health-related quality of life (OHRQoL)
时间窗: Assessed at the 12-month follow-up visit after implant placement.
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Prosthodontic maintenance events
时间窗: Throughout 12 months after overdenture delivery.
The incidence of prosthodontic repair/adjustment events will be recorded during the clinical assessments.
次要结局
- Peri-implant bone change(Peri-implant bone loss at the 12-month follow-up compared to initial stage (1-week rediograph).)
- Maximum voluntary bite force(Assessed at the 12-month follow-up visit after implant placement.)
- Suppuration(Assessed at 12-month post-insertion)
- Bleeding on probing(Assessed at 12-month post-insertion)
- Masticatory Performance(Assessed at the 12-month follow-up visit after implant placement.)
- Probing depth(Assessed at 12-month post-insertion)
研究者
Cláudio Rodrigues Leles
Full Professor
Universidade Federal de Goias