A Comparative Study of the Healing Status by the Use of Alvogyl and Platelet-Rich Fibrin in the Treatment of Alveolar Osteitis: A Randomized Double-Blind Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Mean Pain Score
研究概览
简要总结
Alveolar osteitis, commonly known as dry socket, is a painful complication that can occur after tooth extraction, particularly following removal of a mandibular third molar. It occurs when normal healing of the extraction socket is disrupted and is commonly associated with significant pain and delayed healing. Alvogyl is a commonly used dressing for managing dry socket and can provide rapid pain relief. Platelet-rich fibrin (PRF) is a preparation made from the patient's own blood that contains platelets, white blood cells, fibrin, and growth factors that may promote tissue repair and wound healing.
This randomized controlled clinical trial will compare Alvogyl and platelet-rich fibrin in patients diagnosed with alveolar osteitis following third molar extraction. A total of 102 eligible adult participants will be randomly assigned to receive either Alvogyl or PRF as treatment for the affected extraction socket.
The study will compare the healing outcomes of the two treatments by assessing pain intensity and the number of exposed socket walls during follow-up. Pain will be assessed using a visual analogue scale, while socket healing will be evaluated clinically by recording the number of exposed socket walls.
The study aims to determine whether PRF provides better healing outcomes than conventional Alvogyl treatment for alveolar osteitis. The findings may help clinicians select an effective treatment approach for reducing pain and promoting healing in patients with dry socket.
详细描述
Alveolar osteitis, commonly referred to as dry socket, is a frequent painful complication following tooth extraction. It is characterized by persistent or increasing postoperative pain, typically developing within the first few days after extraction, and may be associated with an empty extraction socket, foul odour, and delayed local healing. The condition can substantially affect patient comfort and quality of life and may require additional clinical management.
Several treatment approaches have been used for alveolar osteitis, including socket irrigation, local dressings, analgesics, antibiotics in selected circumstances, and regenerative materials. Alvogyl is a commonly used intra-alveolar dressing that is intended to provide symptomatic relief and protect the affected socket. Although it can provide rapid pain relief, concerns have been raised regarding its potential effect on the rate of socket healing.
Platelet-rich fibrin (PRF) is an autologous platelet concentrate prepared from the patient's own venous blood without the use of anticoagulants. During centrifugation, a fibrin-rich matrix containing platelets and leukocytes is formed. This matrix serves as a scaffold for tissue repair and provides a sustained release of biologically active mediators, including growth factors involved in angiogenesis, cellular proliferation, and wound healing. PRF has therefore been investigated as a regenerative treatment for extraction socket healing and alveolar osteitis.
Previous clinical studies comparing Alvogyl and PRF have reported differences in pain relief and socket healing. Some evidence suggests that Alvogyl may provide more rapid symptomatic pain relief, whereas PRF may promote more favourable or faster clinical healing. However, variation in study findings and treatment protocols indicates a need for further controlled clinical investigation.
This study is designed as a randomized, double-blind, controlled clinical trial comparing Alvogyl with PRF for the treatment of alveolar osteitis following third molar extraction. Eligible participants will be randomly allocated to receive either Alvogyl or an autologous PRF membrane. Both treatment groups will undergo standardized socket irrigation and debridement before placement of the assigned treatment. The extraction socket will subsequently be secured using sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Participants of either sex.
- •Patients presenting with alveolar osteitis following third molar extraction, diagnosed according to the study's operational definition.
- •Patients willing to participate in the study and provide informed consent.
- •Patients willing and able to attend the scheduled postoperative follow-up assessments.
排除标准
- •Patients with a smoking habit.
- •Patients with a history of bleeding disorders.
- •Patients unwilling or unable to attend the required follow-up sessions.
- •Patients with a history of hypertension, diabetes mellitus, liver disease, or renal disease.
- •Pregnant or breastfeeding individuals.
- •Patients using medications that may affect healing or study outcomes, including bisphosphonates, systemic steroids, or antidepressants.
研究组 & 干预措施
Platelet-Rich Fibrin Group
Participants diagnosed with alveolar osteitis will receive autologous platelet-rich fibrin (PRF). Ten millilitres of venous blood will be collected and centrifuged without anticoagulant to prepare a PRF membrane. Following standard socket irrigation and debridement with warm saline, the PRF membrane will be placed into the extraction socket and secured with 3-0 silk sutures using a figure-of-eight technique. No topical or systemic antibiotics will be administered.
干预措施: Platelet-Rich Fibrin (PRF) (Biological)
Alvogyl Group
Participants diagnosed with alveolar osteitis will receive standard socket irrigation with warm saline and debridement, followed by placement of Alvogyl into the extraction socket. The socket will be secured with 3-0 silk sutures using a figure-of-eight technique. No topical or systemic antibiotics will be administered.
干预措施: Alvogyl Dressing (Procedure)
结局指标
主要结局
Mean Pain Score
时间窗: Postoperative Day 1 and 3
Pain intensity will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. The mean VAS pain score on postoperative Days 1 and 3 will be compared between the Alvogyl and platelet-rich fibrin groups.
Mean Number of Socket Wall Exposures
时间窗: Days 1 and 3
The number of exposed socket walls will be assessed by clinical examination on postoperative Days 1 and 3. The mean number of socket wall exposures will be compared between the Alvogyl and platelet-rich fibrin groups to evaluate the healing status of the extraction socket.
次要结局
未报告次要终点
研究者
Mannal Sohail
Doctor
CMH Lahore Medical College and Institute of Dentistry
