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临床试验/NCT05595746
NCT05595746已完成不适用

Evaluation of the Relationship Between Vertical Mucosal Thickness and Radiological Bone Loss of Platform-Switching Implants Placed at Different Levels

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月5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
80
试验地点
1
主要终点
Radiographic peri-implant marginal bone loss

研究概览

简要总结

One of the criteria used for long-term implant success is the evaluation of radiographic bone loss. It is known that the keratinized mucosa over the alveolar crest forms a protective barrier against inflammatory infiltration. In addition, it has been reported that the vertical mucosal thickness on the crest is important in the formation of the biological width around the implant. The aim of this study was to evaluate the effect of vertical mucosal thickness on the alveolar crest on peri-implant marginal bone loss around crestal and subcrestal placed platform-switching implants. In this study, patients will be divided into 2 main groups with vertical mucosal thickness of 2 mm and less and more than 2 mm, and both groups will consist of 2 subgroups as crestally and subcrestally according to the implant level placed. A total of 80 implants will be included, 20 implants in each group. Before starting the surgery, after anesthesia is given, the width of the patient's peri-implant keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be measured. Clinical and radiological measurements will be made in all patients during the prosthetic loading session (T0), at 3rd month (T1), 6th month (T2) and 1 year after loading (T3). With standardized control periapical radiographs to be taken as a result of one-year follow-up, the marginal bone loss amount in the implants will be evaluated using soft-ware.

详细描述

Dental implants have become one of the most common treatments used for the rehabilitation of lost teeth. The success rate of dental implant treatment is quite high. One of the criteria used for long-term implant success is the evaluation of radiographic bone loss. It is known that the keratinized mucosa over the alveolar crest forms a protective barrier against inflammatory infiltration. It has been reported that the vertical mucosal thickness over the alveolar crest in the operation area before dental implant treatment is important in the formation of the biological width around the implant. There are studies in the literature examining the effects of vertical mucosal thickness on peri-implant marginal bone loss. In a study presented by Linkevicius et al., in 2014, they divided 80 patients into 2 groups according to their mucosal thickness. It was reported that radiological bone loss was 1.17 mm in the group with low vertical mucosal thickness at the end of 1-year follow-up, and 0.21 mm in the group with high vertical thickness.

The aim of the study was to evaluate the effect of vertical mucosal thickness on the alveolar crest on peri-implant marginal bone loss around crestal and subcrestal placed platform-switching implants.

Before starting the surgery, after the patient is anesthetized, the width of the peri-implant keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be measured. In this study, patients will be divided into 2 main groups with vertical mucosal thickness of 2 mm and less and more than 2 mm, and both groups will consist of 2 subgroups as crestal and subcrestal according to the implant level placed.

It is planned to use the same brand of implant and platform-switch abutment in patients. With standardized control periapical radiographs to be taken as a result of one-year follow-up, the marginal bone loss amount in the implants will be evaluated using software. Routine clinical and radiological measurements will be repeated in all patients at the prosthetic loading session (T0), at 3 months (T1), at 6 months (T2), and 1 year after loading (T3). Pre-surgical radiographs will be taken from the patients who participated in our study, as in all implant patients Clinical measurements.

  1. Plaque index (Löe & Silness) and gingival index (Silness & Löe) are obtained by measuring 4 regions of a tooth (mesial, distal, buccal and lingual) with a Williams periodontal probe.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants are assigned a number by hiding their names. While the measurements are being made, the researcher does not know which group the participant belongs to. All radiographic and clinic measurements are collected in one file.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •>18 years old
  • •The patient does not have any systemic disease
  • •Implants are placed in the fully healed alveolar bone
  • •There is no need for horizontal and vertical augmentation in the area where the implant will be placed.
  • •Interocclusal distance higher than 7 mm
  • •Cooperative patients
  • •At least 9 mm of alveolar bone in the patient's mandible or maxilla in the area where the implant will be placed

排除标准

  • •Pregnant and lactation
  • •Mentally retarded patients
  • •Immediate loading
  • •Alveolar bone defects
  • •Smoking more than 10 cigarettes per a day
  • •Immunsupression or deficiency on bone metabolism

研究组 & 干预措施

equicrestally placement with higher vertical mucosa

Experimental

Implants with a vertical mucosal height greater than 2 mm (A) and placed equicrestally (I) are in group A-I.

干预措施: dental implant placement (Procedure)

subcrestally placement with higher vertical mucosa

Experimental

Implants with a vertical mucosal height greater than 2 mm (A) and placed subcrestally (II) are in group A-II.

干预措施: dental implant placement (Procedure)

equicrestally placement with less vertical mucosa

Experimental

Implants with a vertical mucosal height of 2 mm or less (B) and placed equicrestally (I) are in group B-I.

干预措施: dental implant placement (Procedure)

subcrestally placement with less vertical mucosa

Experimental

Implants with a vertical mucosal height of 2 mm or less (B) and placed subcrestally (II) are in group B-II.

干预措施: dental implant placement (Procedure)

结局指标

主要结局

Radiographic peri-implant marginal bone loss

时间窗: 1 year after prosthetic loading

It is the result to be obtained by radiographic evaluation of peri-implant marginal bone loss of 4 study groups formed by vertical mucosal height and implant placement levels.

次要结局

  • Marginal bone loss related keratinized gingival thickness(1 year after prosthetic loading)
  • Marginal bone loss related keratinized gingival height(1 year after prosthetic loading)
  • Evaluation of clinical peri-implant health with bleeding on probing index(1 year after prosthetic loading)
  • Evaluation of clinical peri-implant health with pocket depth on probing index(1 year after prosthetic loading)
  • Evaluation of clinical peri-implant health with plaque index(1 year after prosthetic loading)
  • Evaluation of clinical peri-implant health with gingival index(1 year after prosthetic loading)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berceste Guler

Assoc. Prof.

Kutahya Health Sciences University

研究点 (1)

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