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临床试验/NCT03229005
NCT03229005已完成不适用

Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter Study

International Piezosurgery Academy2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
implant survival

研究概览

简要总结

The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.

详细描述

The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort observational study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.

All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before surgery. With the help of a dissector, a full thickness vestibular flap will be carefully arranged and the vertical thickness of soft tissues will be measured with a probe marked every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be considered thick. After the measurement, the lingual flap will be elevated at full thickness, and the site for site placement will be prepared. The implant bed will be at least 1.5 mm from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be placed at the level of the bone crest according to the manufacturer's recommendations. Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All implants will be submerged according to a traditional two-stage protocol. After insertion, the flaps will be sutured without tension with interrupted sutures. Patients of both groups will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for connecting the healing abutments with a crestal incision that will retain the keratinized tissue; The same soft tissue measurements will be repeated as confirmation of what was done during the first surgical implant insertion phase. The implants will be considered osteointegrated successfully if they are clinically intact unless they show obvious radiotransparency and patients will not report any pain. After this step, it will be possible to divide the patients into 2 groups according to the thickness of the soft tissue: a group with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will result in the formation of 4 different subgroups: a group with thick tissue and high prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.

All the implants will be rehabilitated by the dentist with screwed restorations. After prosthetic treatment, patients will receive oral hygiene instructions and will be monitored through calls to ensure periodontal health throughout the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • General inclusion criteria were:
  • age>18 years;
  • good general health;
  • non smokers;
  • absence of systemic diseases affecting bone metabolism and wound healing; - no regular medication consumption for at least 3 months prior to treatment; - patient willing and fully capable to comply with the study protocol;
  • written informed consent given.
  • Local inclusion criteria were:
  • presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm; - bone crest with at least 6 mm of width and 9 mm of height above the mandibular canal, without concomitant or previous bone augmentation procedures;
  • presence of the opposing dentition.

排除标准

  • history of head or neck radiation therapy;
  • uncontrolled diabetes (HBA1c >7.5%);
  • active infections;
  • immunocompromised patients (HIV infection or chemotherapy within the past 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • patient pregnancy or lactating at any time during the study;
  • poor oral hygiene and motivation;
  • untreated periodontal disease;
  • psychological or psychiatric problems;
  • alcohol or drugs abuse;
  • participating in other studies, if the present protocol could not be properly followed;
  • lack of implant primary stability.

研究组 & 干预措施

A1 thick-high

Active Comparator

group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: implant insertion (Procedure)

A1 thick-high

Active Comparator

group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: operculectomy (Procedure)

A1 thick-high

Active Comparator

group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: prosthetic rehabilitation (Procedure)

A2 thick-low

Experimental

group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: implant insertion (Procedure)

A2 thick-low

Experimental

group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: operculectomy (Procedure)

A2 thick-low

Experimental

group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: prosthetic rehabilitation (Procedure)

B1 thin-high

Active Comparator

group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: implant insertion (Procedure)

B1 thin-high

Active Comparator

group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: operculectomy (Procedure)

B1 thin-high

Active Comparator

group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: prosthetic rehabilitation (Procedure)

B2 thin-low

Experimental

group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: implant insertion (Procedure)

B2 thin-low

Experimental

group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: operculectomy (Procedure)

B2 thin-low

Experimental

group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

干预措施: prosthetic rehabilitation (Procedure)

结局指标

主要结局

implant survival

时间窗: after 12 months

clinical and radiographical examination

peri-implant bone resorption

时间窗: after 12 months

intraoral radiographs will be acquired and bone crest level will be compared with baseline

次要结局

  • peri-implant bone resorption(24 months after prosthetic loading)
  • complications and/or adverse events(any time of the study)

研究者

发起方
International Piezosurgery Academy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mr. Claudio Stacchi, DDS, MSc

President of the Academy

International Piezosurgery Academy

研究点 (2)

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