| 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 |
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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
|
|
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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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Facial swelling
3. Trismus
4. Number of rescue analgesics
|
on 1st, 3rd and 7th post operative day
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| any other complication if arise will be noted |
on 1st, 3rd & 7th post operative day |
|
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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
|
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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.
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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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