| CTRI Number |
CTRI/2024/11/076441 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing the Effectiveness of Aqua Titan Patch in Reducing Postoperative Complications After Wisdom Tooth Surgery: A Randomized Control Trial |
|
Scientific Title of Study
|
EVALUATION OF EFFICACY OF AQUA TITAN PATCH IN POSTOPERATIVE SEQUELAE AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY – A RANDOMIZED CONTROL 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 Neha Patel |
| Designation |
Post graduate student |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral & Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
Udaipur RAJASTHAN 313001 India |
| Phone |
9265940764 |
| Fax |
|
| Email |
patelnehac44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral & Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
Udaipur RAJASTHAN 313001 India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shallu Bansal |
| Designation |
Professor & Head |
| Affiliation |
Geetanjali Dental and Research Insitute |
| Address |
Department of Oral & Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
RAJASTHAN 313001 India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Dental And Research Institute,Geetanjali University, Udaipur |
|
|
Primary Sponsor
|
| Name |
Geetanjali Dental & Research Institute |
| Address |
Department of Oral & Maxillofacial Surgery
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
|
| Type of Sponsor |
Research institution |
|
|
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 Shallu Bansal |
Geetanjali Dental & Research Institute, Udaipur |
Geetanjali Dental & Research Institute
MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA Udaipur RAJASTHAN |
9116155666
drshallu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research ethic committee of Geetanjali university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
aqua titan patch |
aqua titan patch will be used to rule out the efficacy in post operative pain, swelling and trismus after impacted mandibular third molar surgery |
| Comparator Agent |
dynaplast as a placebo |
Dynaplast as a placebo will be compared with aqua titan patch after impacted mandibular third molar surgery in post operative sequalae. |
|
|
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.
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.
•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.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Swelling
Trismus |
all these parameters will be measured on 1st, 3rd and 7th post operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
12/11/2024 |
| 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 Applicable |
| 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
|
Extraction of mandibular third molar is most accomplished procedure in oral surgery. The prevalence of impacted lower third molar ranges from 16.7% - 68.8%. Indication for third molar surgery includes pericoronitis, periodontal defect on distal aspect of 2nd molar, dental caries, involvement of mandibular 3rd molar in various odontogenic tumors and cyst and 6 months prior to Bilateral sagittal split osteotomy.
Pain, oedema, and trismus are the most common post-operative sequalae
after surgical removal of the mandibular third molar which may affect the quality of life of the patient. These post-operative sequelae
further depend upon the location,
depth, tooth angulation, bone density and duration of the surgery.
Various studies had been done in literature
with various methods to improve the control of pain, oedema, and trismus and to accelerate
postoperative recovery period.
These attempts
include use of various anesthesia
alone and in combinations, corticosteroids, incorporation of drains,
platelet rich-plasma, using high or low speed rotatory instruments for osteotomy, cryotherapy, postoperative ice-packs, lasers, and physiotherapy.
Titanium has been reported to have beneficial physiological effects such as anti-inflammatory, anti-tumor, anti-oxidant, and stimulation of nerve cell growth. As per Rowlands
et al the application of aqua titan patch has been advantageous for the repair of muscle-tendon components. Basically, aqua titan is a material
compromising microscopic titanium particles dispersed
in water, achieved
through a processing
technology, developed by phiten co. (Kyoto, Japan). Aqua titan can be applied to many products
in collaboration with other materials
to promote health in daily life and has received attention recently in variety of fields.
Nishiyama et al reported that aqua titan- permeated
patches are beneficial
in relieving TMD- related pain in improving
TMD-related limitation to daily function by local application to most painful area, including
the muscle and joints of patients and advantages for relieving muscle pain.
There are ample number of studies
in literature regarding
the use of NSAIDS, steroids,
PRP, PRF, lasers,
cryotherapy for the management of post-operative pain, swelling and trismus. As per best of our knowledge, there is scarcity of literature regarding
the use of aqua titanium
patch for the management of pain, swelling
and trismus after impacted mandibular
third molar surgery.
Therefore, the present study will be done to evaluate
the efficacy of aqua titanium patch in post- operative sequel after mandibular third molar surgery |