跳至主要内容
临床试验/CTRI/2024/05/067302
CTRI/2024/05/067302已完成4 期

Effect low-level laser therapy as an adjunct to single flap approach technique in the treatment of intrabony defects using demineralised freeze-dried bone allograft

Golapala naga aishwarya1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Early healing index (EHI),Radiographic bone gain measurement

研究概览

简要总结

Periodontitis is an infectious disease, resulting in inflammation within the supporting tissues of the teeth which lead to periodontal pocket deepening, loss of attachment and bone. Intrabony defects are those with apical location of base of the pocket relative to bone crest.Demineralized freeze‐dried bone allograft (DFDBA) is an allograft that harbor’s a variety of growth/differentiation factors, notably bone morphogenetic proteins (BMPs) 2, 4, and 7.Single-flap approach (SFA) is one of the periodontal flap designs proposed to minimize the surgical trauma.LLLT is based on the biostimulation effect, which is based on the fact that cellular behavior can be changed by irradiation at a particular wavelength. Both SFA and LLLT have beneficial effects on probing pocket depth reduction, periodontal wound healing, and obtaining clinical attachment.All the recruited patients will be receiving phase I therapy which includes scaling and root planing which will be performed by single operator. Oral hygiene instructions will be given. Two weeks after SRP all clinical and radiological parameters will be recorded.A buccal envelope flap will be made using Sulcular incisions in the surgical area following the gingival margin of the teeth.Upon completion of the root instrumentation, defect depth, defect width, and wall present will be measured. Control group will receive only DFDBA biomaterial after surgical debridement. In the test group LLLT (Diode laser, Woodpecker) irradiation with 976‐nm wave length at 1.5 W, continuous wave for 5s before surgical debridement will be done and DFDBA biomaterial will be placed.At wound closure vertical internal mattress suture will be placed.Sutures will be removed after two weeks and EHI wound healing index will be recorded. The surgical site will be evaluated on the basis of the clinical parameters will be recorded after 3- and 6-months and radiographic parameters will be recorded after 6 months.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients of age 25 – 55 years.
  • 2 Apparently healthy patients.
  • 3 Probing depth of≥6mm.
  • 4 Patients with Interproximal 2 or 3 wall intrabony defect in the posterior teeth with radiographic evidence of vertical bone loss ≥3mm.
  • 5 Patients willing to participate in the study.

排除标准

  • 1 Presence of any systemic disease.
  • 2 Pregnant women and lactating mothers.
  • 3 Use of any form of tobacco.
  • 4 Having habits like bruxism and night clenching 5 Having history of drug usage and allergy 6 Patients who are under periodontal therapy from the past 6months.

结局指标

主要结局

Early healing index (EHI),Radiographic bone gain measurement

时间窗: Baseline,2weeks,3months,6months

次要结局

  • Reduced Probing Pocket depth ,Clinical attachment level,Gingival recession depth(Baseline,3months,6months)

研究者

发起方
Golapala naga aishwarya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Golapala naga aishwarya

Sibar institute of dental sciences

研究点 (1)

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