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临床试验/CTRI/2020/02/023547
CTRI/2020/02/023547尚未招募2 期

Evaluation of photo-biomodulation for periodontal healing and preservation of tooth vitality in luxation injuries of immature permanent incisors - A preliminary study

CDER1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
CDER
入组人数
30
试验地点
1
主要终点
Healing of Soft Tissues and maintenance of Tooth Vitality

研究概览

简要总结

The purpose of this preliminary study is to determine the effect of photo-biomodulation for periodontal healing and preservation of tooth vitality in luxation injuries of immature permanent incisors.

Photo-biomodulation used along-with splinting protocol (IADT 2012) in immature permanent incisors with luxation injuries during initial phase will lead to better periodontal healing and preserve the vitality of the tooth during the study period, in comparison to the injured teeth managed by splinting protocol (IADT 2012) alone.

Hence, we hypothesized that photo-biomodulation using 940nm nm diode laser can improve healing and preserve tooth vitality in subluxation and lateral luxation of immature permanent incisors.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Immature permanent incisors with subluxation injuries or lateral luxation with/without uncomplicated crown fractures.
  • Patients reporting on the same day or within 24 hours of Traumatic Dental Injury.
  • Patients giving assent and parents consenting to participate in the study.

排除标准

  • Traumatic dental injuries other than lateral luxation and subluxation such as complicated crown fracture, crown root fracture, root fracture, dentoalveolar fracture, concussion, intrusive luxation, extrusive luxation and tooth avulsion.
  • Associated maxillofacial trauma in the region.
  • Combination trauma indicated for endodontic management.
  • Patients suffering from any chronic systemic diseases or on long term medications.
  • Teeth with dental caries (any signs and symptoms of pulpitis).
  • Teeth with signs of loss of tooth vitality (like discoloration, non-tender on percussion, absence of pain, no response to pulp testing).

结局指标

主要结局

Healing of Soft Tissues and maintenance of Tooth Vitality

时间窗: 2 weeks | 1 months | 3 months | 6 months | 12 months

次要结局

  • Clinical Healing(Gingival Health)

研究者

发起方
CDER
申办方类型
Research institution and hospital

研究点 (1)

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