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临床试验/CTRI/2025/10/096090
CTRI/2025/10/096090尚未招募4 期

Clinical Efficacy of Freshchlor Mouth rinse in Post-periodontal flap Surgery Healing- A randomized controlled clinical trial

Group Pharmaceutical LTD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1.To evaluate wound healing outcomes following the use of Freshchlor plus mouthwash post-periodontal flap surgery on days 3, 7, and 14 utilizing the wound healing index,

研究概览

简要总结

Maintenance of high level of oral hygiene plays a crucial role in success of any oral surgical procedure (1). Reduction of biofilm formation, prevention of infective complications on wound site and wound stability are very important for early wound healing (2). Reduction or elimination of oral biofilms is necessary to restore gingival tissues to a healthy state especially after a surgical procedure (3). However, mechanical means are often inadequate in ensuring plaque control and preventing infection at surgical sites (2,3). So, chemical agents can be used along with mechanical plaque control methods to ensure early wound healing (2).

Chlorhexidine is a widely used chemical antiplaque agent routinely prescribed to patients after common oral surgical procedures (1)(3)(4). It is a cationic bisbiguanide and has broad spectrum antimicrobial activity against gram positive bacteria, gram negative bacteria, yeast, viruses leading to chlorhexidine being a gold standard for oral biofilm prevention (3)(4).

A new mouthwash containing Hydrogen peroxide .1%, lactoferrin .05% and Zinc Lactate .14% is being tried for its beneficial effects on periodontal wound healing due to the individual constituents. Lactoferrin is a known antimicrobial agent and effects biofilm formation (5,6,7)

Orsi 2024 stated that Lactoferrin (Lf) is a multifunctional iron glycoprotein which is known to exert a broad-spectrum primary defense activity against bacteria, fungi, protozoa and viruses. Its iron sequestering property is at the basis of the bacteriostatic effect, (8)

Hydrogen peroxide is seen to be an antibacterial agent and a wound healing promotor (9,10,11) and Zinc has an important role in wound healing. (12)

H2O2 has been reported to be a reactive biochemical molecule synthesized by various cells that influences biological behavior through multiple mechanisms: alterations of membrane potential, generation of new molecules, and changing intracellular redox balance, which results in activation or inactivation of different signalling transduction pathways. Contrary to the traditional viewpoint that H2O2 probably impairs tissue through its high oxidative property, a proper level of H2O2 is considered an important requirement for normal wound healing.(11)  As it is widely known that for the completion of wound healing; hemostasis by platelet activating factors, growth factors and cytokines followed by inflammatory response by the body leading to removal of bacteria, foreign bodies and damaged tissues accompanied with angiogenesis, fibroblast proliferation, collagen synthesis and maturation is absolutely necessary. (5)

Therefore, this study aims to evaluate the efficacy Freshchlor + mouthwash containing Hydrogen peroxide .1%, lactoferrin .05% and Zinc Lactate .14%   in post periodontal flap surgery healing in comparison with Chlorhexidine 0.2% mouthwash .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • (1) Patient who are indicated for periodontal flap surgery (2) Systemically healthy older than 18 years (3) With basic communication, reading and writing skills (4) Willingness to sign an informed consent form Exclusion criteria; (1) Surgeries other than periodontal flap surgery (2) Systematic diseases and psychological or medical disorders that might influence pain threshold (5) acute intraoral pain (periodontal or endodontic pain) (6) Hypersensitivity to the mouthwash ingredients.

排除标准

  • ; (1) Surgeries other than periodontal flap surgery (2) Systematic diseases and psychological or medical disorders that might influence pain threshold (5) acute intraoral pain (periodontal or endodontic pain) (6) Hypersensitivity to the mouthwash ingredients.

结局指标

主要结局

1.To evaluate wound healing outcomes following the use of Freshchlor plus mouthwash post-periodontal flap surgery on days 3, 7, and 14 utilizing the wound healing index,

时间窗: 3,7,14 days

2. To evaluate wound healing outcomes following the use of .0.2% chlorhexidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 days using wound healing index.

时间窗: 3,7,14 days

3.To evaluate the PROM (patient reported outcome measures) among both the groups using Visual analogue scale and analgesic intake

时间窗: 3,7,14 days

4.To conduct both intergroup and intragroup comparisons

时间窗: 3,7,14 days

次要结局

  • To evaluate the PROM (patient reported outcome measures) among both the groups using Visual analogue scale and analgesic intake

研究者

发起方
Group Pharmaceutical LTD
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr David K

manipal college of dental sciences ,mangalore

研究点 (1)

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