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临床试验/CTRI/2025/07/091508
CTRI/2025/07/091508尚未招募2/3 期

Efficacy of a Mucoadhesive gel containing Manuka Honey and Vitamin C on healing of post extraction wound : A Randomized control study

GDC AND H Mumbai1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
1. Pain on VAS

研究概览

简要总结

Tooth extraction or Dental extraction is a procedure done by the dentist for removal of a tooth from the dental socket. Inflammation and Infection occur by the bacteria, microbes, and fungi which leads to pain, redness, swelling, chronic infection, and severe bleeding.

Dental sockets undergo several ordered events during the healing process, including inflammation, overlapping stages of haemostasis, remodelling, and maturation. After a teeth extraction, there may be post-operative complications, such as pain and swelling, which could last for several days. To reduce these problems and accelerate healing, various systemic drugs, natural products, preservative materials, and irrigation techniques to be used.

Tooth extraction often leads to an open wound that requires effective and rapid healing to prevent complications such as infection, delayed recovery, and patient discomfort. Traditional treatments like zinc oxide and eugenol provide antimicrobial and soothing effects, but they often lack additional bioactive components that actively promote tissue regeneration and accelerated healing. Manuka honey, with its potent antibacterial and anti-inflammatory properties, combined with vitamin C, a well-known antioxidant that supports collagen synthesis and tissue repair, presents a promising alternative for enhancing post-extraction wound healing.

Moore showed that Manuka honey has “very special healing properties” and described it as “the best natural antibiotic in the world.” It was found that the topical application of honey clears existing wound infection rapidly; facilitates healing of deeply infected surgical wounds; and halts spreading necrotizing fasciitis.4 It has also promoted healing of infected wounds that were not responding to conventional therapy such as antibiotics and antiseptics, including wounds that were infected with antibiotic-resistant bacteria such as methicillin-resistant Staphyloccocus aureus (MRSA).

Vitamin C, also known as ascorbic acid (vit.c), was shown to modify the epigenetic/gene expression profile and extracellular matrix. Vitamin C contributes to the health of the cardiovascular, immunological and nervous system and also supports healthy bone, lung, and skin function and wound healing. The mechanism of action of vitamin C in human health is as diverse as its targets and effects. For example, vitamin C functions as an antioxidant, signals changes in gene expression, plays a role in protein metabolism, and serves a cofactor in several biosynthetic pathways including collagen synthesis. The role of vitamin C in support of improved wound healing during the re-epithelialization stage. While vitamin C supports wound healing in early stages by reducing inflammation, vitamin C continues to support wound healing by promoting collagen synthesis and epithelial cell migration in the re-epithelialization stage.

Presently, the most effective post-operative care for tooth extraction is systemic antibiotic and analgesics to eradicate inflammation & prevent infections. To enhance the local drug delivery, the concept of muco-adhesion is being introduced. Thus, a formulation in the form of gel can be considered appropriate for healing of tooth extraction socket. Considering that the systemic medication cause several side effects, this study will evaluate efficacy of a gel to eradicate inflammation & prevent infections, thereby avoiding side effect of systemic medications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients indicated for bilateral extraction.
  • Patients not suffering from any Co-morbidities.
  • ASA category -I patient.

排除标准

  • Patients with acute dental infection.
  • Immunocompromised patients.
  • Pregnant & lactating female patient
  • patient currently on medication for any medical condition
  • ASA category- II, III, IV.

结局指标

主要结局

1. Pain on VAS

时间窗: Day 1 | day 3 | day 7

2. Extraoral Swelling

时间窗: Day 1 | day 3 | day 7

3. wound healing

时间窗: Day 1 | day 3 | day 7

次要结局

  • Inflammatory marker: CRP(day 1)

研究者

发起方
GDC AND H Mumbai
申办方类型
Other [Government dental college ]
责任方
Principal Investigator
主要研究者

Vinita Patil

goverment dental college and hospital

研究点 (1)

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