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CTRI Number  CTRI/2025/05/087246 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Piezo surgery Alone versus Piezo surgery with Dexamethasone in post operative sequalae following impacted mandibular third molar: A Clinical Trial 
Scientific Title of Study   COMPARATIVE EVALUATION OF PIEZOSURGERY VERSUS PIEZOSURGERY WITH INTRAMUSCULAR DEXAMETHASONE IN POSTOPERATIVE SEQUELAE IN THE EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  PIMDEX Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr LATIKA MANGHNANI  
Designation  Post graduate student 
Affiliation  Geetanjali Dental and Research Institute 
Address  MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9414734465  
Fax    
Email  latika.manghnani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shallu Bansal 
Designation  Pro essor and Head 
Affiliation  Geetanjali Dental & Research Institute 
Address  MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Latika manghnani 
Designation  Post graduate student 
Affiliation  Geetanjali Dental & Research Institute 
Address  MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001


RAJASTHAN
313001
India 
Phone  9414734465  
Fax    
Email  latika.manghnani@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr LATIKA MANGHNANI  
Address  Geetanjali Dental college and Research Institute Udaipur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shallu Bansal  Geetnajali Dental And Research Institute  MANAVA KHEDA, GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001
Udaipur
RAJASTHAN 
9116155666

drshallu23@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethical Committee Geetanjali University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Piezo surgery with intramuscular dexamethasone for the impacted mandibular third molar   Study group- in this we will give intramuscular dexamethasone half an hour prior to surgery and we will do dis impaction with piezo surgical unit  
Comparator Agent  Piezosurgery alone for the extraction of mandibular third molar  control group- in this we will do dis-impaction with piezo surgery alone  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Patients between age of 18-45 years of both genders.
2) Patients indicated for surgical removal of impacted mandibular third molar with moderately difficult score as per modified Pederson difficulty index.
3) Healthy patients falling under ASA I and ASA II
4) Subjects able and willing to provide written informed consent and compliant with study procedure
 
 
ExclusionCriteria 
Details  1. Patients with mouth opening less than 30mm.
2. Patient with allergy with NSAIDS.
3. Patients having history of drug abuse.
4. Patients having any systemic or local immunodeficiency.
5. Patient is under regular analgesics and anti-depressants.
6. Having any blood coagulation impairment.
7. Presence of any acute oral infection.
8. Have been suffering with uncontrolled diabetes or other systemic diseases.
9. Having previous history of radiation therapy in the head and neck region.
10. Having previous history of chemotherapy.
11. Pregnant and nursing women.
12. Soft tissue impactions.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain
2. Facial swelling
3. Trismus
4. Number of rescue analgesics
 

on 1st, 3rd and 7th post operative day
 
 
Secondary Outcome  
Outcome  TimePoints 
any other complication if arise will be noted  on 1st, 3rd & 7th post operative day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 an inflammatory cascade, which activates biological reactions such as pain, swelling, and trismus [20]. A wide collection of drugs has been prescribed to prevent postoperative inflammation. Among these, corticosteroids are one of the utmost broadly used classes of drugs due to their solid anti-inflammatory action and relative safety in healthy patients [21-23]. Corticosteroids reduce inflammation by the repression of phospholipase A2, the primary enzyme involved in the transformation of phospholipids into arachidonic acid. 

 

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.

 

 
 
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