| CTRI Number |
CTRI/2023/11/059700 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of 2 different medications in reducing of swelling, trismus and pain after mandibular third molar extraction. |
|
Scientific Title of Study
|
Effectiveness of intra-socket application of dexamethasone soaked gelfoam and injection hyaluronic acid soaked gelfoam following mandibular third molar extraction. |
| 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 Vanshika Bajpai |
| Designation |
Post graduate student |
| Affiliation |
Mcods, Manipal |
| Address |
Room No 4,Department of oral and maxillofacial surgery,Manipal college of dental sciences Manipal,Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
7860328764 |
| Fax |
|
| Email |
vanshika.mcodsmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chithra A |
| Designation |
Associate professor |
| Affiliation |
Mcods, Manipal |
| Address |
Room No 4,Department of oral and maxillofacial surgery,Manipal college of dental sciences Manipal,Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9481939772 |
| Fax |
|
| Email |
chitra.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chithra A |
| Designation |
Associate professor |
| Affiliation |
Mcods, Manipal |
| Address |
Room No 4,Department of oral and maxillofacial surgery,Manipal college of dental sciences Manipal,Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9481939772 |
| Fax |
|
| Email |
chitra.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental science, Manipal will provide the material support |
|
|
Primary Sponsor
|
| Name |
Manipal college of dental sciences manipal |
| Address |
Room No 4,Department of oral and maxillofacial surgery,Manipal college of dental sciences Manipal,Karnataka. |
| 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 Chithra A |
Manipal college of dental sciences,Manipal |
Room No 4,Department of oral and maxillofacial surgery,Manipal college of dental sciences Manipal,Karnataka.
Udupi
KARNATAKA |
9481939772
chitra.a@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MANDIBULAR THIRD MOLAR IMPACTED TEETH |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexamethasone soaked gelfoam and injection hyaluronic acid soaked gelfoam following mandibular third molar extraction. |
Doasage- Gelfoam soaked in 8mg dexamethasone
Gelfoam soaked in 4mg Hyaluronic acid
Freqency- Either of the comparator agent will be put once after the procedure according to randomisation
Route of administration- Topical
Duration - 45minutes to 1hour |
| Intervention |
Extraction of mandibular third molar |
The procedure will be carried out by the surgical team and local anaesthesia (LA with 2% adrenaline) will be given for the lower third molar which consist of-
Trunk anesthesia of Inferior alveolar nerve.
Homolateral lingual nerve
Long Buccal nerve infiltration.
Then full thickness Envelope flap will be done followed by bone guttering with saline irrigation and tooth will be split to eliminate obstructions in the path of removal.
After the surgical extraction, copious irrigation of the extraction socket will be done and then the Gelfoam alone/dexamethasone soaked gelfoam/Hyaluronic acid soaked gelfoam will be placed in the socket followed by suturing of the socket.
However the current standard of care is -Gelfoam alone.
Post-surgery, the patients were given a post-operative instructions sheet with local measures and medical treatment-
Amoxicillin and potassium clavulanate tablets- 625 mg- t.i.d for 5 days.
Metronidazole tablets- 400 mg- t.i.d for 5 days.
Ibuprofen tablets- 200 mg- to be taken based on the nature of the pain.
and a follow-up appointment will be scheduled on Day 3rd and Day 7th. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with previous dental symptoms (for example, acute pericoronitis, pain, or caries of the second or third molar due to malposition or impaction resulting in the retention of food). |
|
| ExclusionCriteria |
| Details |
1. Patients younger than 18 years old or older than 50 years old.
2. Patients with disabilities, allergies, and/or intolerances to the medications used in the study.
3. Patient undergoing anticoagulant, oncological or bisphosphonate treatment.
4. Patient with any systemic pathology that could affect the effect.
5. Patient with wisdom teeth and associated odontogenic cysts or active infection.
6. Patients who have received locoregional radiation therapy or prior surgery on the lower retromolar trigone
7. Pregnant women
8. Anyone who did not wish to participate in the study or did not authorize their participation. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in post-operative pain and trismus and oedema after lower third molar extraction in all the groups- gelfoam alone, dexamethasone soaked gelfoam and Injection Hyaluronic acid soaked gelfoam.
|
Measurements of swelling, trismus and post-operative pain will be done immediately just before the surgery,third and seventh day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in usage of medications & acceleration of wound healing in all the groups. |
Medications & acceleration of wound healing will be recorded on third & seventh day |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="0"
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
|
Third molar surgery is one of the most prevalent done treatments in the oral cavity. However surgeons often encounter undesirable post-extraction sequelae which may badly affect a patient’s quality of life. Post-operative complications from third molar surgery after the surgical trauma and release of local mediators are well known which includes pain, inflammation, loco-regional oedema and limited mouth-opening ability with consequent functional restrictions that limits speech and mastication. Various medicinal options are used to decrease the complications and accelerate healing which includes local/systemic steroids, NSAIDS and antibiotics. The corticosteroids help to decrease pain, edema and trismus post-extraction, however some practitioners do not prefer its usage as it may delay wound healing whereas on the other hand Hyaluronic acid accelerates wound healing by inducing fast granulation tissue production, restricting the destruction from inflammation and inducing re-epithelialization with angio-genesis and thereby decreasing pain and edema. Due to lack of comparative studies between the two- dexamethasone and hyaluronic acid in literature, more research regarding the same is highly recommended. |