| CTRI Number |
CTRI/2025/07/090395 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different systems of bone removal in 3rd molar extractions surgery. |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of Piezo Surgical System Versus Conventional Drilling Techniques in Healing Outcomes Following Tooth Extraction in Patients with Oral Submucous Fibrosis: A Randomized Controlled Trial.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyot Sarvaiya |
| Designation |
1st Year Resident |
| Affiliation |
Government Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361002
India |
| Phone |
8733950146 |
| Fax |
|
| Email |
jyotsarvaiya7777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajbir Kaur Randhawa |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361002
India |
| Phone |
9065999990 |
| Fax |
|
| Email |
dr.rrandhawa23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361002
India |
| Phone |
9824282509 |
| Fax |
|
| Email |
drnishitomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Jyot Sarvaiya |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Jamnagar |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Jyot Sarvaiya |
Government Dental College and Hospital, Jamnagar |
Department of Oral and Maxillofacial Surgery, Room no 4, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT |
8733950146
jyotsarvaiya7777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shree M.P. Shah Govt. Medical College and G.G. Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K010||Embedded teeth, (2) ICD-10 Condition: K01||Embedded and impacted teeth, (3) ICD-10 Condition: K02||Dental caries, (4) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, (5) ICD-10 Condition: K05||Gingivitis and periodontal diseases, (6) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drill system |
extraction of mandibular third molar with micro motor, hand piece , along with normal saline irrigation for bone removal around the third molar |
| Intervention |
Piezoelectric surgical system |
Extraction of mandibular third molar in which bone removal will be done with peizo surgical system which generates micro vibrations to cut the bone |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with oral sub mucous fibrosis
Age between 25 to 60 years
Mouth Opening between 15mm to 35mm
Mandibular third molar teeth indicated for surgical extraction(Pederson score: Slightly difficult and moderately diffiicult[3-6]
Patient willing to participate in the study and available for long term follow up
Teeth cannot be saved endodontically |
|
| ExclusionCriteria |
| Details |
Patients with cardiac pacemakers
Patients with systemic diseases(ASA-2, ASA-3, ASA-4)
Age less than 25 years and greater than 60 years
Patients with bleeding and clotting disorders
Patients with a history of allergies or adverse effects to local aesthetic agents |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative pain
Swelling
Wound Healing |
1st 3rd and 7th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative
Patient reported comfort
Acceptability
Duration of operative intervention |
Same day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/07/2025 |
| 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="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A study titled as a comparative clinical evaluation of piezo surgical system versus conventional drilling techniques in healing outcomes following tooth extraction in patients with oral submucous fibrosis, a randomized controlled trial compares piezoelectric surgical system with conventional drilling techniques in mandibular third molar extraction in patients with oral submucous fibrosis. Oral submucous fibrosis can complicate third molar extraction due to fibrosis and limited mouth opening. The primary outcome of the study is to evaluate post operative pain, swelling and wound healing and secondary outcome of the study is to evaluate intra operative patient reported comfort, acceptability and duration of operative intervention during extraction. Sixty patients diagnosed with oral submucous fibrosis are randomly assigned to either group. Piezoelectric surgery uses ultrasonic vibrations for precise bone cutting, reducing tissue damage and bleeding, while conventional drilling can cause more trauma. |