Does Vitamin C Improve Postoperative Healing: A Randomized Split-Mouth Clinical Trial After Impacted Mandibular Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Postoperative Facial Swelling
研究概览
简要总结
This randomized, split-mouth clinical trial investigates the effect of oral vitamin C supplementation on postoperative recovery following the surgical extraction of impacted mandibular third molars. Fifty-six healthy patients underwent bilateral extractions, with each side randomly assigned to receive either 1000 mg of oral vitamin C or a placebo. The supplementation began one day before surgery and continued through postoperative day 7. The outcome measures included facial swelling assessed through linear measurements (tragus-pogonion, tragus-commissure labiorum, and lateral canthus of the eye-angulus mandible), pain using a visual analog scale (VAS), trismus based on maximum interincisal opening, and early wound healing assessed with the Landry healing index. Analgesic consumption was also recorded. Pain was evaluated using VAS on days 1, 2, and 7. Edema, trismus, and early wound healing were evaluated on postoperative days 2 and 7. The study aims to determine whether vitamin C reduces edema, pain, and trismus, and enhances early soft tissue healing compared to placebo.
详细描述
This randomized, split-mouth clinical trial aimed to investigate the effect of oral vitamin C supplementation on postoperative recovery following the surgical extraction of impacted mandibular third molars. A total of 56 healthy patients requiring bilateral lower third molar extractions were included in the study. Each patient underwent two separate surgeries on both sides, with each side randomly assigned to receive either 1000 mg of oral vitamin C or a placebo.
Vitamin C supplementation started one day prior to surgery and continued for seven days postoperatively. The primary outcomes of the study were facial swelling, pain, trismus, and early soft tissue healing. Facial swelling was assessed using three linear measurements between specific anatomical landmarks: tragus-pogonion, tragus-labial commissure, and lateral canthus of the eye-angulus mandible. Trismus was measured based on maximum interincisal distance. Pain was evaluated using the visual analog scale (VAS) on postoperative days 1, 2, and 7. Edema, trismus, and early wound healing were assessed on postoperative days 2 and 7. Early wound healing was scored using the Landry healing index. Analgesic consumption was also recorded during the postoperative period.
This study was designed to evaluate whether vitamin C supplementation could reduce postoperative edema, pain, and trismus, and improve early soft tissue healing in comparison to placebo in the context of oral surgical procedures. The findings may provide evidence to support the use of vitamin C as an adjunctive therapy in oral surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study was designed as a double-blind trial. Both the participants and the outcome assessors were blinded to the allocation of the intervention (vitamin C or placebo). The tablets were identical in appearance, taste, and packaging to ensure blinding integrity. Allocation concealment was maintained by a third party responsible for randomization and distribution of the supplements. The clinical evaluator who performed the postoperative measurements (pain, swelling, trismus, and wound healing) was not informed about the intervention administered to each surgical site. Participants were also unaware of which side received vitamin C or placebo.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years
- •Systemically healthy
- •Non-smoker
- •No alcohol or substance abuse
- •Bilateral impacted mandibular third molars
- •Mesioangular impaction with a Pederson index of 5-6
- •Voluntary participation
- •Ability and willingness to attend follow-up visits
排除标准
- •Pregnancy or lactation
- •Presence of infection or pain related to third molars
- •Associated pathological conditions (e.g., cysts or tumors)
- •History of previous mandibular third molar extraction
- •Congenital absence of third molars
- •Known allergy to any drug or substance used in the study
研究组 & 干预措施
Placebo
Patients received an identical-looking placebo tablet once daily for the same duration.
干预措施: Placebo (Other)
Vitamin C
Patients received 1000 mg of oral vitamin C daily starting one day before surgery through postoperative day 7.
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Postoperative Facial Swelling
时间窗: Postoperative Day 2 and Day 7
Facial swelling was measured using three linear distances: tragus-pogonion, tragus-labial commissure, and lateral canthus-mandibular angle.
Postoperative Pain Score (VAS)
时间窗: Postoperative Days 1, 2, and 7
Pain intensity was assessed using a 10-cm visual analog scale (VAS), with 0 = no pain and 10 = worst possible pain.
次要结局
- Trismus (Maximum Interincisal Opening)(Postoperative Days 2 and 7)
- Early Wound Healing (Landry Healing Index)(Postoperative Days 2 and 7)
- Analgesic Consumption(Postoperative Days 1,2 and 7)
研究者
Alper AKTAŞ
Professor
Hacettepe University