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临床试验/CTRI/2025/05/087246
CTRI/2025/05/087246尚未招募不适用

COMPARATIVE EVALUATION OF PIEZOSURGERY VERSUS PIEZOSURGERY WITH INTRAMUSCULAR DEXAMETHASONE IN POSTOPERATIVE SEQUELAE IN THE EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR: A RANDOMIZED CONTROLLED TRIAL

Dr LATIKA MANGHNANI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
3. Trismus

研究概览

简要总结

Surgical extraction of the impacted third molar is one of the most performed surgical procedures in the field of Oral and Maxillofacial Surgery [1]. The incidence of third molars impaction ranges from 9.5 to 68% in young adults and these teeth frequently erupt between the ages of 17 and 21 years old [2-4]. Due to the amplified occurrence of lower third molars impaction, and the connection of many complications with these impacted teeth, assessment of third molars surgery in terms of indications, surgical techniques, symptoms, and postoperative sequelae becomes a necessity to offer patients high-quality care and minimize their suffering. The procedure difficulty may range from pretty easy to extremely difficult, depending on its depth, angulation, and the resistance of the surrounding bone [5]. Surgical removal of these teeth is typically correlated with postoperative pain, facial swelling, and trismus while complications such as infection, dry socket, inferior alveolar nerve, or lingual nerve injuries are less common to occur [6,7].

One of the most perilous steps in mandibular third molar surgery is the removal of the covering bone or osteotomy, for which many techniques are used. The usage of hand tools such as osteotome, chisel, or gouge for bone procedures in oral surgery has a very long record. In daily practice, rotating instruments like drills are used for osteotomy during oral surgery. However, bone overheating and destruction to adjacent tissues are disadvantages correlated with the usage of these techniques, because they produce extremely high temperatures, which can launch peripheral osteonecrosis and impede bone regeneration and wound healing.

 Several advanced methods have been introduced and tested in the extraction of the impacted wisdom teeth [8-10]. Marie and Jean Curie first presented piezoelectric equipment which uses ultrasound technology in 1880 [11]. Its application to oral surgery was first recommended in the late 1980s by Horton et al. However, a dedicated machine for this purpose was introduced recently by Vercellotti, an Italian surgeon to overcome the limitations of rotatory instruments in oral surgery. Also well-known as ‘pressure electrification’, it has been well-defined by the term ‘piezo’ derived from ‘piezein,’ meaning the pressure in the Greek language [12,13]. The advantage of Piezosurgery is that it uses ultrasonic micro-vibrations to remove bone with minimal harm to the adjacent tissues, which leads to quick postoperative wound healing. Ultrasonic osteotomy might improve the efficiency of cuts and, directly, reduce the morbidity rate subsequent from iatrogenic injuries [14,15].

In many recent studies, postoperative pain was compared in patients with impacted mandibular third molars treated by piezoelectric surgery or by rotary osteotomy technique; they concluded that the piezo-surgery osteotomy technique produced less facial swelling and less postoperative pain [7,16,17]. Thus, numerous authors have suggested using piezoelectric devices to achieve osteotomies as an alternative to rotary instruments [18,19].

Surgery-associated trauma initiates aninflammatory cascade, which activates biological reactions such as pain,swelling, and trismus [20]. A wide collection of drugs has beenprescribed to prevent postoperative inflammation. Among these, corticosteroidsare one of the utmost broadly used classes of drugs due to their solidanti-inflammatory action and relative safety in healthy patients [21-23].Corticosteroids reduce inflammation by the repression of phospholipase A2, theprimary enzyme involved in the transformation of phospholipids into arachidonicacid.

 In addition, the use of anti-inflammatory medications is the prevalent attitude to decrease postoperative complications. Dexamethasone is known to be more powerful than other anti-inflammatory drugs because of its extended duration of action. It is related to an essential reduction of prostaglandins and leukotrienes; therefore, dexamethasone is one of the most frequently used corticosteroids [24]. Different routes of administration were used, such as oral administration, submucosal injection, and intramuscular injection, which have been shown to give equivalent results. However, the intramuscular route is popular in the field of oral and maxillofacial surgery due to its effectiveness and simplicity. Numerous studies have compared postoperative sequelae after the third molar in patients treated with or without dexamethasone injection; the majority confirmed that dexamethasone injection remarkably reduced postoperative pain, trismus, and facial swelling [21, 22, 25].

There are numerous studies where the comparison of Piezosurgery with conventional bur has been done and evidence of Dexamethasone with rotary instrument. But there is a lacunae in the studies where Piezosurgery alone and piezosurgery with dexamethasone has been compared in the extraction of impacted mandibular third molar.

Thus, the aim of the present study is to compare the Piezosurgery with combined effect of piezo-surgery and intra muscular dexamethasone injection on postoperative sequelae after the surgical extraction of impacted mandibular third molars.

Null hypothesis (H0) behind the present study is that there is no difference in the piezosurgery alone with piezosurgery and intra muscular dexamethasone injection on postoperative sequelae after impacted mandibular third molar surgery.

Alternate hypothesis (H1) is that piezosurgery with intra muscular dexamethasone is more effective than piezosurgery alone in postoperative sequelae after impacted mandibular third molar surgery.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients between age of 18-45 years of both genders.
  • Patients indicated for surgical removal of impacted mandibular third molar with moderately difficult score as per modified Pederson difficulty index.
  • Healthy patients falling under ASA I and ASA II 4) Subjects able and willing to provide written informed consent and compliant with study procedure.

排除标准

  • Patients with mouth opening less than 30mm.
  • Patient with allergy with NSAIDS.
  • Patients having history of drug abuse.
  • Patients having any systemic or local immunodeficiency.
  • Patient is under regular analgesics and anti-depressants.
  • Having any blood coagulation impairment.
  • Presence of any acute oral infection.
  • Have been suffering with uncontrolled diabetes or other systemic diseases.
  • Having previous history of radiation therapy in the head and neck region.
  • Pregnant and nursing women.
  • Soft tissue impactions.

结局指标

主要结局

3. Trismus

时间窗: on 1st, 3rd and 7th post operative day

1. Pain

时间窗: on 1st, 3rd and 7th post operative day

2. Facial swelling

时间窗: on 1st, 3rd and 7th post operative day

4. Number of rescue analgesics

时间窗: on 1st, 3rd and 7th post operative day

次要结局

  • any other complication if arise will be noted(on 1st, 3rd & 7th post operative day)

研究者

发起方
Dr LATIKA MANGHNANI
申办方类型
Research institution and hospital

研究点 (1)

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