| CTRI Number |
CTRI/2024/10/075745 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Materials to Help Heal the bone After Removing Wisdom Teeth of lower jaw |
|
Scientific Title of Study
|
Comparison of efficacy of intra-socket application of Nano Hydroxyapatite with Hyaluronic Acid and Collagen as graft material after surgical removal of impacted mandibular 3rd molar - A Randomized Split-Mouth Clinical 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. Himanshu Jain |
| Designation |
1st year Post Graduate (MDS) |
| Affiliation |
Yenepoya Dental college |
| Address |
1st floor,Department of Oral and Maxillofacial Surgery
Yenepoya Dental College, Deralakatte,
MANGALORE
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9772230689 |
| Fax |
|
| Email |
hj9772230@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Rao HT |
| Designation |
Additional professor |
| Affiliation |
Yenepoya Dental college |
| Address |
1st floor,Department of Oral and Maxillofacial Surgery
Yenepoya Dental College, Deralakatte,
MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448142508 |
| Fax |
|
| Email |
arvind_raoht@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Rao HT |
| Designation |
Additional professor |
| Affiliation |
Yenepoya Dental college |
| Address |
1st floor,Department of Oral and Maxillofacial Surgery
Yenepoya Dental College, Deralakatte,
MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448142508 |
| Fax |
|
| Email |
arvind_raoht@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Himanshu jain
Department of Oral and Maxillofacial Surgery
Yenepoya Dental College and Hospital,
Yenepoya University
Mangalore, Dakshina Kannada
Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Himanshu Jain |
| Address |
Yenepoya Dental college
Mangalore
Karnataka |
| 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 HIMANSHU JAIN |
Yenepoya Dental College and Hospital |
1st floor,
Department of Oral and Maxillofacial Surgery
Dakshina Kannada
KARNATAKA |
9772230689
hj9772230@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committe 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted mandiibular 3 molar |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroxyapatite with collagen |
G graft Hydroxyapatite with collagen as graft material mixed saline/venous blood will be placed as graft material in the extracted socket
normal saline or autologous venous blood will be mixed with hydroxyapatite and collagen come as powder and block form which can be readily used after removal from the package
both will be mixed together in a time frame of less than 10 mins approximately
Mixture of these will be placed in the socket
the graft material will be placed permanently in the socket and does not require any secondary intervention |
| Intervention |
hydroxyapatite with hyaluronic acid graft material |
G bone - Hydroxyapatite with 2% hyaluronic acid will be mixed together chairside after extraction
hyaluronic acid comes in solgel form in a syringe and hydroxyapatite come as powder and block form which can be readily used after removal from the package
both will be mixed together in a time frame of less than 5mins approximately
Mixture of these materials will be placed in the socket
the graft material will be placed permanently in the socket and does not require any secondary intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1 patient .
Age 18-40 years.
Bilateral similar impacted mandibular third molars. |
|
| ExclusionCriteria |
| Details |
Patients with any bony pathologies.
Patients with any hormonal imbalance which affects bone healing.
Patients on corticosteroids or oral contraceptives.
Pregnant and lactating mothers.
Patient allergic to any of the graft materials used in this study.
Patients with history of deleterious habits such as alcohol consumption, smoking, etc.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the efficacy of hydroxyapatite with hyaluronic acid on postoperative pain and swelling after third molar removal.
Assess the effect of hyaluronic acid on trismus after third molar extraction.
Compare wound healing and bone density after using hydroxyapatite with collagen or hyaluronic acid grafts post-mandibular third molar extraction |
Compare pain using the Visual Analog Scale on the 1st, 7th, and 15th postoperative days after each extraction on the same patient.
Measure swelling using gonion-lateral canthus and tragus-angle of mouth distances on the 1st, 7th, and 15th postoperative days.
Assess wound healing using Landrys Index on the 1st, 7th, and 15th postoperative days.
Evaluate mouth opening or trismus on the 1st, 7th, and 15th postoperative days.
Take OPG on the 30th day post-op to assess bone density.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess a better morbidity & decrease of post op complications by fore said parameters |
follow up after 1, 7, 15
for measuring pain, swelling, mouth opening & wound healing after each extraction
follow up after 1 month of each extraction for OPG xray |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="11" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
16/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
As the the 3rd molar disimpaction is one of the most common surgical procedure performed in Oral and Maxillofacial Surgery, there is a need to reduce the unpleasant postoperative sequelae and provide newer methods of bone regenerative grafts to enhance and hasten the bone healing.
The surgical removal of Mandibular 3rd molar is a routinely performed minor oral surgical procedure with certain postoperative sequelae affecting the quality of life for some duration This study is conducted to evaluate efficacy of Hyaluronic Acid as an adjuvant to newer generation of graft materials. The duration of the study is approximately 2 month. Group of 11 participants are included in this study who have to undergo treatment for surgical removal of mandibular third molar.
Patients will recalled for follow up in time of 1,7,15 day to evaluate post operative pain,swelling,wound healing and mouth opening. They will be recalled after 30th day after removal of tooth for radiographic evaluation. |