Comparison of Intrasocket Application of Hyaluronic Acid+Gelfoam Vs Gelfoam Alone to Reduce Post-Operative Pain and Trismus after Surgical Extraction of Lower Wisdom Teeth
Compare the effectiveness of intra-socket application of HA+gelfoam vs gelfoam (placebo) alone to reduce the post-op pain and trismus.
Design
Prospective, Split-mouth, Double-blinded Randomized controlled trial. Intervention group Hyaluronic Acid+Gelfoam, Control group-Gel-foam alone. Single center study.
Settings and conduct
After taking ethical approval, 15 patients matching the inclusion criteria will be selected from the Out patient department of Oral and Maxillofacial surgery, CMH Medical College & Institute of Dentistry, Lahore. Surgical extraction will be performed by a single surgeon (researcher herself) under local anesthesia (LA). Decided Material will be placed into the socket and closure with silk sutures will be done. The patient will be prescribed antibiotics and analgesics. Post-operatively pain and trismus will be evaluated on the 1st, 2nd and 7th day by using Numerical rating scale (NRS) and ruler measuring Inter-incisal distance in millimeters. Score will be documented by co-researcher to eliminate bias.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
18-40 years of age
Non-smoker, non-alcoholic, similar difficulty level on both sides according to Pederson scale
Exclusion Criteria:
systolic blood pressure (>140 mmHg,< 90 mmHg ), diastolic (>90mmHg , <60mmHg)
Any history of allergy or adverse effects to antibiotics, analgesics, or local anesthetics.
Acute infection
Any physical or mental disability.
Pregnant woman and any use of contraceptives or corticosteroids
Any patient taking antibiotics and analgesics for 15 days before operation
Taken antidepressants 5 days before the surgery
Intervention groups
Group that receives Intrasocket Hyaluronic Acid+ Gelfoam
Main outcome variables
Pain and Trismus after Surgical Extraction of Lower Wisdom Teeth on 1st 2nd and 7th post operative day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240301061136N1
Registration date:2024-03-28, 1403/01/09
Registration timing:prospective
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
Registrant information
Name
Rida Binte Zahid
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry Lahore
Country
Pakistan
Phone
+92 42 35929717
Email address
ridabintezahid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-01, 1403/06/11
Expected recruitment end date
2025-03-01, 1403/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intrasocket Application of Hyaluronic Acid+Gelfoam Vs Gelfoam Alone to Reduce Post-Operative Pain and Trismus after Surgical Extraction of Lower Wisdom Teeth
Public title
Effect of Intrasocket Application of Hyaluronic Acid
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 years of age
Do not have any systemic disease
Non-smoker, Non-alcoholic
symmetrically impacted third molars on both sides of the mandible
Require surgical extraction of impacted teeth
Similar difficulty level on both sides according to Pederson scale
Gave consent for participation
Exclusion criteria:
systolic blood pressure (>140 mmHg,< 90 mmHg ), diastolic (>90mmHg , <60mmHg).
Any history of allergy or adverse effects to antibiotics, analgesics, or local anesthetics
Acute infection such as pericoronitis and/or complication or pain on the impaction area before extraction
Any physical or mental disability
Pregnant woman and any use of contraceptives or corticosteroids which can affect the postsurgical complication of healing and amount of swelling on the face
Tobacco use in any form
Any patient taking antibiotics and analgesics for 15 days before operation
Taken antidepressants 5 days before the surgery
Non-cooperative patient
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Both sides requiring extraction. On one side Hyaluronic Acid with Gel-foam will be placed and on the other side only Gel-foam will be placed.
Randomization (investigator's opinion)
Randomized
Randomization description
Two lists of integers will be generated via www.random.org representing the two groups (Hyaluronic Acid + gel-foam vs Gel-foam alone). Each side of the patient’s mouth will be allotted a sample number. The integers will then be looked up in the list generated to decide which material has to be placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will not know which material is placed on which side of the mouth. Post-operatively, pain will be evaluated on the 1st, 2nd and 7th day by using Numerical rating scale (NRS) and trimus will be evaluated through Inter-incisal distance. Score will be documented by co-researcher to eliminate bias.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Office of Research, Innovation & Commercialization (L-ORIC) CMH Lahore Medical College & Institute o
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2023-12-08, 1402/09/17
Ethics committee reference number
ORIC-CMH-LMC-2023-0097
Health conditions studied
1
Description of health condition studied
Post operative pain and trismus (mouth opening)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain and trismus
Timepoint
1st 2nd and 7th post operative day
Method of measurement
Pain measured through NRS and Trismus is the Inter-incisal distance measured in mm using a ruler
Secondary outcomes
1
Description
Dry socket and painkiller use
Timepoint
3rd 4th and 7th post operative day
Method of measurement
Visual assessment of dry socket symptoms. Painkiller use measured by the number of tablets used post operatively
Intervention groups
1
Description
Intervention group: this is the site of surgical extraction which will receive Hyaluronic acid+ Gelfoam within the socket. 1.7ml of 20mg/2ml Hyaluronic Acid will be used (Hylagun prefilled injections) along with Gelfoam (haemostatic gelatin sponge) as a scaffold. After surgical extraction Gelfoam will be impregnated with Hyaluronic Acid which will then be placed within the extraction socket and closure will be done with silk 3.0 sutures.
Category
Treatment - Other
2
Description
Control group: this is the site of surgical extraction which will receive Gelfoam (haemostatic gelatin sponge) alone. This is used as placebo to compare the effect of our intervention. After the delivery of the tooth. The socket will be filled with Gelfoam and closure will be done with silk 3.0 sutures.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY LAHORE
Full name of responsible person
Dr. Rida Binte Zahid
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 324 8980000
Email
ridabintezahid@gmail.com
Web page address
https://cmhlahore.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Dr. Rida Binte Zahid
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 324 8980000
Email
ridabintezahid@gmail.com
Web page address
https://cmhlahore.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Lahore Medical College and Institute of Dentistry
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Dr. Rida Binte Zahid
Position
Post graduate trainee
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35929717
Email
ridabintezahid@gmail.com
Web page address
https://cmhlahore.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Dr. Rida Binte Zahid
Position
Post graduate trainee
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35929717
Email
ridabintezahid@gmail.com
Web page address
https://cmhlahore.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Dr. Rida Binte Zahid
Position
Post graduate trainee
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35929717
Email
ridabintezahid@gmail.com
Web page address
https://cmhlahore.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the collected IPD
When the data will become available and for how long
6 months after publication
To whom data/document is available
People working in academic institutes
Under which criteria data/document could be used
By mailing a request. Data can be used to help them establish there study protocol
From where data/document is obtainable
Email ID
What processes are involved for a request to access data/document
Provide official information on an institutional letter head along with a mail.