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IRCT20240301061136N1 IRCT 2024-03-28 CMH Lahore Medical College and Institute of Dentistry Effect of Intrasocket Application of Hyaluronic Acid 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 2024-09-01 anticipated 15 Complete https://irct.ir/trial/75801 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, 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 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. N/A Post operative pain and trismus (mouth opening). Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Rida Binte Zahid
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
Lahore Pakistan 54000 +92 42 35929717 ridabintezahid@gmail.com CMH Lahore Medical College and Institute of Dentistry scientific Dr. Rida Binte Zahid
G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab
Lahore Pakistan 54000 +92 42 35929717 ridabintezahid@gmail.com CMH Lahore Medical College and Institute of Dentistry Pakistan 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 18 years 40 years Both 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 Treatment - Other Placebo 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. 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. 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. 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. CMH Lahore Medical College and Institute of Dentistry Approved 2023-12-08 Office of Research, Innovation & Commercialization (L-ORIC) CMH Lahore Medical College & Institute o G9QC+GGM CMH Lahore Medical College, Abdul Rehman Rd, Sarwar Colony, Lahore, Punjab Lahore Punjab Pakistan