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临床试验/CTRI/2024/11/076557
CTRI/2024/11/076557尚未招募不适用

Effectiveness of Laser photobiomodulation using confluence of two wavelength photons in inhibiting pain and enhancing extraction wound healing compared to sham Laser in 6 to 25 year old individuals: A double blind randomized controlled trial

School of Dental Sciences2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
2
主要终点
Laser photobiomodulation using confluence of 640nm and 810nm wavelength photons is expected to be effective in inhibiting post operative pain and enhancing the extraction wound healing in 6 to 25 year old individuals.

研究概览

简要总结

Local anesthesia is pivotal in inhibiting pain during dental procedures, yet the pain induced by needle insertion often leads to non-compliance in the children, apprehension in the adolescents and young adults. Traditional approaches like topical local anesthetics, cryo-anesthesia, and acupressure may not adequately alleviate pain or promote optimal wound healing, necessitating the exploration of alternative strategies. Laser photobiomodulation (PBM) therapy is non-invasive and effective in enhancing the tissue regeneration and wound healing. It also decreases the pain and edema through anti-inflammatory effect. Harnessing the therapeutic potential of confluent use of red and near infrared spectrum laser PBM is least researched. Hence, this study is designed to evaluate the effectiveness of laser PBM using confluence of 640nm and 810nm wavelength photons in inhibiting pain and enhancing extraction wound healing in 6 to 25 year old individuals. It is a split mouth double blind randomized controlled trial. Thirty participants each, in the age groups of 6-12 years, 12-18 years and 18-25 years fulfilling the inclusion and exclusion criteria will be enrolled in to the study after parental consent and participant’s consent/assent. The allocation of the side and test or control sub-group will be done with lottery method, followed by allocation concealment for blinding purpose. The test side will receive confluent laser PMB of 640nm and 810nm (100mW 640nm + 100mW of 810nm) using continuous wave in contact mode for 60 seconds (The energy delivered will be 12J) at the injection site before inferior alveolar nerve block (IANB) anesthesia and the control side will receive sham laser. Similarly, the test side will receive confluent laser PBM after extraction of mandibular tooth at 3 to 4 points with same Laser parameters in non-contact mode and the control side will receive sham laser after tooth extraction. The pain of injection will be evaluated by Wong-Baker faces pain rating scale and Face, Legs, Activity, Cry, Consolability (FLACC) scale. The pulse rate will be evaluated before during and after the IANB anesthesia as biological indicator. The postoperative pain will be evaluated by Wong-Baker faces pain rating scale and healing of extraction wound by Healing index of Landry, Turnbull and Howley in the follow-up visits at 3, 7 and 15 days. The data will be complied and analyzed using appropriate statistical tests. The confluent laser PBM is expected to be effective in pain control and enhancing extraction wound healing.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Healthy children in the age group of 6-12 year, adolescents in 12-18 years and young adults in the age range of 18-25 years.
  • Children exhibiting cooperative behaviour (Frankl behavior rating 3 and 4)
  • Children requiring bilateral extraction of mandibular primary molars, adolescents requiring bilateral extraction of mandibular premolars for therapeutic purposes and adults requiring bilateral extraction of mandibular third molar teeth.
  • Participants/parents willing to provide the consent.
  • Children and adolescents willing to provide the assent.

排除标准

  • Medically compromised individuals
  • Specially abled person
  • Individuals with known allergy to LA (Lignocaine Hydrochloride)
  • Individuals with Bleeding and Clotting Disorders
  • Individuals already under any medications which may alter the pain perception or wound healing
  • Individuals with craniofacial anomalies
  • Individuals with any oropharyngeal soft tissue lesions
  • Children with exfoliating teeth showing grade-3 mobility.

结局指标

主要结局

Laser photobiomodulation using confluence of 640nm and 810nm wavelength photons is expected to be effective in inhibiting post operative pain and enhancing the extraction wound healing in 6 to 25 year old individuals.

时间窗: At baseline, 3 days, 7 days and 15 days.

次要结局

  • Laser photobiomodulation using confluence of 640nm & 810nm wavelength photons is expected to be effective in inhibiting pain of injection during inferior alveolar nerve block anesthesia in 6 to 25 year old individuals.(At baseline, during administration of inferior alveolar nerve block anesthesia.)

研究者

发起方
School of Dental Sciences
申办方类型
Other [Private Dental College and Hospital]
责任方
Principal Investigator
主要研究者

Dr Vinaya Kumar Kulkarni

SMBT Dental College and Hospital

研究点 (2)

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