CTRI/2025/05/087448 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On:
22/05/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Surgical/Anesthesia Dentistry Other (Specify) [two different equipments to be compared]
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Piezoelectric Surgical System for Tooth Extraction in Patients with Oral Cancer
Scientific Title of Study
Comparative Clinical Evaluation of Piezoelectric Surgical System Versus Conventional Methods in the Healing Outcomes After Tooth Extraction in Patients with Oral Cancer: A Double-Blind Randomized Controlled Trial Study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Nishit Kumar
Designation
Tutor
Affiliation
Government dental college and hospital Jamnagar
Address
Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar Jamnagar GUJARAT 361008 India
Phone
9824282509
Fax
Email
drnishitomfs@gmail.com
Details of Contact Person Scientific Query
Name
Nishit Kumar
Designation
Tutor
Affiliation
government dental college and hospital Jamnagar
Address
Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar Jamnagar GUJARAT 361008 India
Phone
9824282509
Fax
Email
drnishitomfs@gmail.com
Details of Contact Person Public Query
Name
Nishit Kumar
Designation
Tutor
Affiliation
GOVERNMENT DENTAL COLLEGE AND HSOPITAL JAMNAGAR
Address
Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar
GUJARAT 361008 India
Phone
9824282509
Fax
Email
drnishitomfs@gmail.com
Source of Monetary or Material Support
Government dental college and hospital navagam ghed ,Jamnagar 361008
Primary Sponsor
Name
Government Dental College And Hospital Jamnagar
Address
Government dental college and hospital pathik ashram road Navagam khed,jamnagar
INSTITUTIONAL ETHICS COMMITTEE SHREE M P SHAH GOVT MEDICAL COLLEGE AND GG GOVT HOSPITAL
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (3) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (4) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (5) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (6) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (7) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (8) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (9) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (10) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (11) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (12) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (13) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (14) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (15) ICD-10 Condition: C023||-2146826259, (16) ICD-10 Condition: C024||Malignant neoplasm of lingual tonsil, (17) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (18) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (19) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (20) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (21) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (22) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (23) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (24) ICD-10 Condition: C052||Malignant neoplasm of uvula, (25) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (26) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (27) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (28) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (29) ICD-10 Condition: C080||Malignant neoplasm of submandibular gland, (30) ICD-10 Condition: C081||Malignant neoplasm of sublingual gland, (31) ICD-10 Condition: C089||Malignant neoplasm of major salivary gland, unspecified, (32) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (33) ICD-10 Condition: C091||Malignant neoplasm of tonsillar pillar (anterior) (posterior), (34) ICD-10 Condition: C098||Malignant neoplasm of overlappingsites of tonsil, (35) ICD-10 Condition: C099||Malignant neoplasm of tonsil, unspecified, (36) ICD-10 Condition: C100||Malignant neoplasm of vallecula, (37) ICD-10 Condition: C101||Malignant neoplasm of anterior surface of epiglottis, (38) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx, (39) ICD-10 Condition: C103||Malignant neoplasm of posterior wall of oropharynx, (40) ICD-10 Condition: C108||Malignant neoplasm of overlappingsites of oropharynx, (41) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (42) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified, (43) ICD-10 Condition: C118||Malignant neoplasm of overlappingsites of nasopharynx, (44) ICD-10 Condition: C113||Malignant neoplasm of anterior wall of nasopharynx, (45) ICD-10 Condition: C112||Malignant neoplasm of lateral wallof nasopharynx, (46) ICD-10 Condition: C111||Malignant neoplasm of posterior wall of nasopharynx, (47) ICD-10 Condition: C110||Malignant neoplasm of superior wall of nasopharynx, (48) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (49) ICD-10 Condition: C138||Malignant neoplasm of overlappingsites of hypopharynx, (50) ICD-10 Condition: C131||Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (51) ICD-10 Condition: C130||Malignant neoplasm of postcricoidregion, (52) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified, (53) ICD-10 Condition: C142||Malignant neoplasm of Waldeyers ring, (54) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (55) ICD-10 Condition: K027||Dental root caries, (56) ICD-10 Condition: K026||Dental caries on smooth surface, (57) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (58) ICD-10 Condition: K023||Arrested dental caries, (59) ICD-10 Condition: K001||Supernumerary teeth, (60) ICD-10 Condition: K003||Mottled teeth, (61) ICD-10 Condition: K030||Excessive attrition of teeth, (62) ICD-10 Condition: K032||Erosion of teeth, (63) ICD-10 Condition: K033||Pathological resorption of teeth, (64) ICD-10 Condition: K034||Hypercementosis, (65) ICD-10 Condition: K036||Deposits [accretions] on teeth, (66) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, (67) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (68) ICD-10 Condition: K041||Necrosis of pulp, (69) ICD-10 Condition: K042||Pulp degeneration, (70) ICD-10 Condition: K050||Acute gingivitis, (71) ICD-10 Condition: K043||Abnormal hard tissue formation inpulp, (72) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (73) ICD-10 Condition: K045||Chronic apical periodontitis, (74) ICD-10 Condition: K046||Periapical abscess with sinus, (75) ICD-10 Condition: K047||Periapical abscess without sinus, (76) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, (77) ICD-10 Condition: K051||Chronic gingivitis, (78) ICD-10 Condition: K054||Periodontosis, (79) ICD-10 Condition: K055||Other periodontal diseases, (80) ICD-10 Condition: K056||Periodontal disease, unspecified, (81) ICD-10 Condition: K063||Horizontal alveolar bone loss, (82) ICD-10 Condition: K084||Partial loss of teeth, (83) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, (84) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (85) ICD-10 Condition: K119||Disease of salivary gland, unspecified, (86) ICD-10 Condition: K130||Diseases of lips, (87) ICD-10 Condition: K131||Cheek and lip biting, (88) ICD-10 Condition: K040||Pulpitis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
conventional drill system
motor driven units are use to cut bone surrounding the tooth during extraction traditional method
Intervention
piezoelectric surgical unit
piezoelectric unit consist of ultrasonic tips which vibrates to cut the bone surrounding the bone studies suggest that healing is good with less preoperative pain
Inclusion Criteria
Age From
21.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Diagnosed with oral cancer
Mouth opening 15mm-40mm
Lower molar teeth indicated for extraction
Tooth/teeth cannot be extracted by closed method
Willingness to participate
Tooth/teeth cannot be saved endodontically
ExclusionCriteria
Details
Cardiac pacemaker
Ongoing chemotherapy
Age less than 20 YEARS or more than 60 years
Bleeding/clotting disorders
Allergies to local anesthetics
Cardiomyopathy
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Case Record Numbers
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Wound healing evaluation
days 4, 7, and 14
Secondary Outcome
Outcome
TimePoints
Postoperative pain evaluated daily using VAS
Postoperative swelling time taken for extraction, excluding suturing
POSTOPERATIVE SWELLING ON 4,7 AND 14 DAY
Target Sample Size
Total Sample Size="140" Sample Size from India="140" 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)
05/06/2025
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="6" 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 - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - For individual participant data meta-analysis.
By what mechanism will data be made available? Response (Others) - data request should be directed to the email id : drnishitomfs@gmail.com
For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970? Response - Beginning 9 months and ending 36 months following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - nil
Brief Summary
THE AIM OF THE STUDY IS TO SEE WHICH METHOD IS BETTER BY LOOKING AT PAIN, SWELLING, HEALING, AND OTHER PROBLEM AFTER THE SURGERY; IT’S IMPORTANT BECAUSE IT HELPS DOCTOR DECIDE WHICH METHOD TO USE BY LOOKING AT THE GOOD AND BAD SIDES OF EACH TECHNIQUES. THE STUDY IS WELL ORGANIZED, WITH ORAL CANCER PALTENTS BETWEEN 25 TO 60 YEARS OLD WHO NEED A TOOTH EXTRACION WILL BE INCLUDED IN STUDY. SOME PEOPLE CAN’T JOIN THE STUDY, LIKE THOSE WITH HEART PACEMAKERS OR WHO ARE TOO YOUNG OR TOO OLD. THE STUDY HAS TWO GROUPS: ONE USES A GENTLE CUTTING TOOL WITH SOUND WAVES WHICH PIEZOELECTRIC MACHINE THAT’S SAFER FOR SOFT TISSUES AND THE OTHER USES TRADITIONAL DENTAL DRILLS THAT ARE MORE COMMON BUT MIGHT HURT TISSUES MORE. THE PATIENTS DON’T KNOW WHICH METHOD IS USED ON THEM AND THE PEOPLE CHECKING THE RESULTS. DON’T KNOW EITHER, THEY JOINTLY LOOK AT HOW WELL THE WOUND HEALS AFTER 4, 7 AND 14 DAYS AND ALSO CHECK PAIN AND SWELLING THEY USE SPECIAL STATISTICS TO MAKE SURE THE RESULTS ARE RELIABLE THE STUDY IS VALUABLE BECAUSE TS GIVES NEW INFORMATION ON HOW TO EXTRACT THE TEETH IN PEOPLE WTH ORAL CANCER, WHICH CAN HELP IN MAKING BETTER TREATMENT DECISIONS