Effects of Titanium-Prepared Platelet-Rich Fibrin and Low-Level Laser Therapy on Postoperative Pain, Swelling, Trismus, and Analgesic Consumption Following Mandibular Third Molar Surgery: A Randomized Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Interincisal Mouth Opening (Trismus)
研究概览
简要总结
This randomized double-blind clinical trial aims to evaluate the effects of titanium-prepared platelet-rich fibrin (T-PRF), low-level laser therapy (LLLT), and their combination on postoperative outcomes following surgical extraction of impacted mandibular third molars. Sixty patients will be randomly allocated to one of four parallel groups: T-PRF, LLLT, T-PRF plus LLLT, or control. The primary outcomes include postoperative pain assessed using a visual analogue scale (VAS), analgesic consumption, postoperative swelling and trismus. The findings may help identify effective approaches for improving postoperative recovery after mandibular third molar surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the outcome assessor were blinded to treatment allocation. Randomization was performed using a lottery-based allocation method by an independent staff member. The operating surgeon, who performed the assigned intervention, was not involved in postoperative outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 31 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults requiring surgical extraction of a unilateral vertically impacted mandibular third molar.
- •Healthy individuals (ASA I or II).
- •Ability to provide written informed consent.
- •Willingness to attend all follow-up visits.
排除标准
- •Systemic disease affecting wound healing.
- •Pregnancy or lactation.
- •Active infection or acute pericoronitis.
- •Long-term opioid use.
- •Smoking and alcohol use.
- •Known allergy to study medications.
- •Previous radiotherapy to the head and neck region
- •Inability to attend follow-up visits.
研究组 & 干预措施
Control
Participants underwent standard surgical extraction of an impacted mandibular third molar without T-PRF placement or active low-level laser therapy.
T-PRF
Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket immediately after mandibular third molar surgery.
干预措施: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) (Procedure)
LLLT
Participants received low-level laser therapy immediately after surgery and once daily for the following two postoperative days.
干预措施: Low-Level Laser Therapy (LLLT) (Device)
T-PRF + LLLT
Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket together with low-level laser therapy immediately after surgery and once daily for the following two postoperative days.
干预措施: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) (Procedure)
T-PRF + LLLT
Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket together with low-level laser therapy immediately after surgery and once daily for the following two postoperative days.
干预措施: Low-Level Laser Therapy (LLLT) (Device)
结局指标
主要结局
Maximum Interincisal Mouth Opening (Trismus)
时间窗: Preoperative baseline and Postoperative Days 1, 2, 3, and 7
Postoperative trismus will be evaluated by measuring the maximum interincisal mouth opening using a calibrated caliper. The distance (in millimeters) between the incisal edges of the maxillary and mandibular central incisors during maximum mouth opening will be recorded for each participant. Lower values indicate greater postoperative trismus.
Postoperative Pain
时间窗: Postoperative Days 1, 2, 3, and 7
Postoperative pain assessed using a 100-mm Visual Analog Scale (VAS).
Analgesic Consumption
时间窗: Postoperative Days 1, 2, 3, and 7
Number of analgesic tablets consumed after surgery.
Facial Swelling
时间窗: Preoperative baseline and Postoperative Days 1, 2, 3, and 7
Postoperative facial swelling will be evaluated using standardized linear facial measurements. Three distances will be measured with a flexible measuring tape: tragus to the corner of the mouth (Tragus-Commissure), tragus to the soft-tissue pogonion (Tragus-Pogonion), and lateral canthus of the eye to the mandibular angle (Lateral Canthus-Gonion). The sum of the three measurements (in centimeters) will be recorded for each participant. Higher values indicate greater postoperative facial swelling.
次要结局
未报告次要终点
研究者
Salih Alpcan
Principal Investigator
NEW Cyprus Health and Social Sciences University