跳至主要内容
临床试验/CTRI/2023/05/052252
CTRI/2023/05/052252招募中不适用

Comparison of Peri-Implant Clinical and Radiological Parameters after using Glycine Air Abrasion, Soft Tissue Diode Laser or Titanium Brush adjunctive to Conventional Peri-Implantitis Therapy: A Randomized Controlled Clinical and Radiological Trial

Dr Dipanshu Pahuja1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
36
试验地点
1
主要终点
1.Probing pocket depth (PPD)

研究概览

简要总结

The use of titanium dental implants for reconstructing the lost dentition has demonstrated a high degree of success in achieving osseointegration (97%–98%) and longâ€term predictability (survival rates of, approximately, 89% after 10 years of service). In spite of this good prognosis, implantâ€related complications, both biological and mechanical, do occur, namely periâ€implant diseases.1 In the 2017 World Workshop on Periodontology, these diseases were classified in two distinct conditions, periâ€implant mucositis defined by the presence of reversible inflammatory changes, as bleeding on gentle probing, erythema, swelling and/or suppuration in the mucosa around an implant and periâ€implantitis, defined as a biofilmâ€associated pathological condition occurring in tissues around dental implants, characterized by inflammation in the periâ€implant mucosa and subsequent progressive loss of supporting bone.

Toma et al4 evaluated and compared the efficacy of three mechanical procedures for surgically treating peri-implantitis and they concluded that the titanium brush and glycine air-polishing device were more effective than the other methods.

Furthermore, Renverts et al.5 conducted the study and compared the treatment effects between air-abrasive (AM) and Er:YAG laser (LM) mono-therapy in cases with severe peri-implantitis. de Tapia et al.1 alsocompared and evaluated an additional mechanical approach, a titanium brush, in the implant surface decontamination performed during the regenerative surgical therapy of periâ€implantitis. But presently there is only few studies reported in literature comparing all these three treatment modalities of periimplantitis. Hence, the aim of present study is to compare clinical and radiological parameters after using glycine air abrasion, soft tissue diode laser or titanium brush adjunctive to conventional peri-implantitis therapy.

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • The patients present with one or more implants showing signs of peri-implantitis with the following conditions will be included in the study: a.Bleeding/suppuration on probing in peri-implant tissues.
  • b.PPD ≥ 3 mm around implants.
  • c.Radiographic evidence of bone loss around implants and/or exposure of implant threads clinically and/or radiographically.
  • d.No occlusal overload (checked by articulating papers).

排除标准

  • a.Acute infection.
  • b.Medically compromised patients.
  • c.Uncooperative patients.
  • d.Heavy smokers.
  • e.Non-compliant patients for oral hygiene maintenance.
  • f.Mechanical failure like fixture fracture g.
  • Habits leading to trauma from occlusion.
  • h.Complete mobility of the implant or advanced periimplantitis lesion (>6mm/>50% implant length exposed) according to Monje et al.’s classification.7 i.Inflammatory diseases with exaggerated responses like rheumatoid arthritis or granulomatous diseases that might influence treatment outcome.
  • j.Patients on long term steroids or bisphosphonates therapy.
  • k.Patient having frank gingivitis or periodontitis in the vicinity of periimplantitis site.

结局指标

主要结局

1.Probing pocket depth (PPD)

时间窗: Baseline, Three months, Six Months and Nine months

2.Relative attachment level (RAL)

时间窗: Baseline, Three months, Six Months and Nine months

3.Marginal bone level (MBL)

时间窗: Baseline, Three months, Six Months and Nine months

4.Stability of implant

时间窗: Baseline, Three months, Six Months and Nine months

次要结局

  • 1.Gingivitis Index (Loe H and Silness J,1963)(2.Plaque index (Turesky-Gilmore-Glickman modification of Quigley-Hein Plaque Index,1970))

研究者

发起方
Dr Dipanshu Pahuja
申办方类型
Other [self sponsored]

研究点 (1)

Loading locations...

相似试验