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临床试验/NCT07738861
NCT07738861进行中(未招募)4 期

Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction: A Randomized Controlled Trial

CMH Lahore Medical College and Institute of Dentistry1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
74
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

Postoperative pain is a common complication following mandibular molar extraction and can negatively affect patient comfort and recovery. Tetracycline is a broad-spectrum antibiotic with anti-inflammatory properties that may reduce postoperative inflammation and pain when applied locally to the extraction socket.

This randomized controlled trial aims to evaluate the effect of intraoperative placement of tetracycline on postoperative pain in patients undergoing surgical extraction of mandibular molars. A total of 74 eligible patients will be randomly assigned to receive either intrasocket tetracycline or no local medicament following tooth extraction. All participants will receive the same standard postoperative care and analgesic regimen. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days after surgery. The findings of this study will provide evidence regarding the effectiveness of local tetracycline in reducing postoperative pain and may help improve postoperative pain management following mandibular molar extraction.

详细描述

Surgical extraction of mandibular molars is one of the most frequently performed procedures in oral and maxillofacial surgery and is commonly associated with postoperative pain, inflammation, and delayed patient recovery. The intensity of postoperative pain is influenced by tissue trauma, inflammatory mediator release, and bacterial colonization of the extraction socket. Although systemic analgesics are routinely prescribed to control postoperative pain, their prolonged use may be associated with adverse effects. Therefore, adjunctive local therapies that can reduce postoperative pain while minimizing systemic medication use are of clinical interest.

Tetracycline is a broad-spectrum antibiotic with additional anti-inflammatory properties. Besides inhibiting bacterial protein synthesis, tetracycline suppresses matrix metalloproteinases, reduces inflammatory cytokine activity, and promotes wound healing. Local application of tetracycline directly into the extraction socket may provide sustained antimicrobial and anti-inflammatory effects at the surgical site, thereby reducing postoperative pain without increasing systemic drug exposure.

Previous clinical studies have reported beneficial effects of locally applied tetracycline in reducing postoperative pain and improving socket healing following dental extractions. However, evidence from the local population remains limited. Differences in patient characteristics, surgical techniques, and healthcare settings necessitate evaluation of this intervention within the Pakistani population.

This study is designed as a prospective, parallel-group, randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, CMH Lahore Medical College and Institute of Dentistry, Lahore. Seventy-four patients requiring surgical extraction of mandibular molars will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or the control group.

Participants in the intervention group will receive 250 mg tetracycline mixed with 0.5 mL sterile saline and placed directly into the extraction socket before wound closure. Participants in the control group will undergo the same surgical procedure without placement of any intrasocket medicament. All surgical procedures will be performed by the same surgeon using a standardized surgical protocol. Postoperative management, including analgesics and oral hygiene instructions, will be identical for both groups.

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
None

盲法说明

This is an open-label study. Participants and the operating surgeon are aware of treatment allocation because the intervention is applied directly into the extraction socket during surgery. Postoperative pain will be assessed using a standardized Visual Analog Scale (VAS).

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 60 years.
  • Male and female participants
  • Patients requiring surgical extraction of a mandibular molar.
  • American Society of Anesthesiologists (ASA) Physical Status I or II
  • Able and willing to provide written informed consent and comply with study follow-up

排除标准

  • Pregnant or lactating women.
  • Patients with systemic conditions that contraindicate oral surgery (e.g., uncontrolled diabetes mellitus or immunosuppressive disorders).
  • Current use of antibiotics or medications that may interfere with wound healing (e.g., anticoagulants or bisphosphonates).
  • Known allergy or hypersensitivity to tetracycline or related antibiotics.
  • Requirement for simultaneous extraction of adjacent teeth.
  • Presence of active oral infection, including pericoronitis, at the surgical site.
  • Severely compromised oral hygiene that may affect postoperative healing.
  • Individuals who are unable to cooperate with the study procedures or attend follow-up visits because of physical or cognitive impairment.

研究组 & 干预措施

Control Group

Other

Participants assigned to this arm will undergo surgical extraction of a mandibular molar without placement of any intrasocket medicament. All participants will receive the same standardized postoperative care, including diclofenac sodium and oral hygiene instructions. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days.

干预措施: No Intrasocket Medicament (Other)

Intrasocket Tetracycline Group

Experimental

Participants assigned to this arm will undergo surgical extraction of a mandibular molar followed by placement of 250 mg tetracycline mixed with 0.5 mL sterile saline directly into the extraction socket before primary wound closure. All participants will receive the same standardized postoperative care, including diclofenac sodium and oral hygiene instructions. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days.

干预措施: Tetracycline (Drug)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: 24 hours, 48 hours, and 7 days after mandibular molar extraction

Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be compared between the tetracycline and control groups to evaluate the effectiveness of intraoperative intrasocket tetracycline placement following mandibular molar extraction.

次要结局

  • Analgesic consumption(Within 7 days after mandibular molar extraction)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Saad Khawar

Doctor

CMH Lahore Medical College and Institute of Dentistry

研究点 (1)

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