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Investigating the effect of Eugenol by gelfoam carrier in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible

Protocol summary

Study aim
The effectiveness of the use of Eugenol in preventing the occurrence of dry socket syndrome after mandibular third molar surgery
Design
This study is a randomized clinical trial, single-blind, phase III clinical trial with a split-mouth design, conducted on 36 patients, using restricted block randomization.
Settings and conduct
This study is a randomized controlled trial (RCT). The research will be conducted on patients referred to the Department of Oral and Maxillofacial Surgery at the Islamic Azad University, Tehran Dental School, during the academic year 2024–2025. Eugenol used in the surgery will be applied with a Gelfoam carrier. In the intervention group, the area will be irrigated and the socket filled with Gelfoam impregnated with eugenol, followed by suturing. Then, in both groups, a sterile gauze will be placed in the area for 30 minutes. The study is single-blinded, and only one evaluator will be involved.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 35 years, lower mandibular third molar teeth, bilaterally Exclusion criteria: Uncontrolled systemic conditions
Intervention groups
All patients undergo surgical extraction of the lower third molar by the same surgeon. After tooth removal, the socket is irrigated, and in the intervention side, the socket is filled with Hemospong gel containing one drop of Eugenol (produced by Golchay Company). In the control side, the socket is only irrigated, and then—similar to the intervention side—the area is sutured using 3/0 Vicryl suture with a 26 mm needle. After irrigation, suturing is performed in the same way for both groups. A sterile gauze is then placed in the surgical site for 30 minutes in both groups. All patients are prescribed amoxicillin 250 mg capsules every 8 hours and ibuprofen 500 mg tablets every 6 hours.
Main outcome variables
Occurrence of dry socket

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250204064639N1
Registration date: 2025-06-04, 1404/03/14
Registration timing: registered_while_recruiting

Last update: 2025-06-04, 1404/03/14
Update count: 0
Registration date
2025-06-04, 1404/03/14
Registrant information
Name
Niyayesh sadat Mirjafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 2969
Email address
h.mesgari@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-16, 1404/01/27
Expected recruitment end date
2025-08-11, 1404/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Eugenol by gelfoam carrier in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible
Public title
Investigating the effect of Eugenol by gelfoam carrier in preventing dry socket syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35 years The impacted third molars of the mandible bilaterally placed In class I, II and III, level A, B and C based on the classification of Paul and Gary Gouri Need to remove the tooth surgically
Exclusion criteria:
Uncontrolled systemic conditions
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 72
More than 1 sample in each individual
Number of samples in each individual: 2
The research is split mouth; on one side of the patient's jaw, an intervention Eugenol is used, along with a foam gel carrier. On the other side, no drug is used, and it is left without intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is block randomization with a fixed block size of 2. This study is designed as a split-mouth trial, meaning that in each participant, one side of the mouth (right or left) will be randomly assigned to the intervention group (application of Eugenol with Gel Foam), and the opposite side will be assigned to the control group (no pharmaceutical intervention). For the random allocation of the intervention side, Random Allocation Software version 1.0 (RAS, ©M. Saghaei, 2004, Isfahan University of Medical Sciences) will be used. The random sequence will be prepared before the start of the study, placed in opaque, sealed, and sequentially numbered envelopes, and used in order of participant enrollment to ensure allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator is unaware of the type of intervention performed, and the study is conducted as a single-blind trial.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Dentistry Faculty - Islamic Azad University of Medical Sciences
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2024-10-14, 1403/07/23
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.136

Health conditions studied

1

Description of health condition studied
Dry socket
ICD-10 code
M27
ICD-10 code description
Other diseases of jaws

Primary outcomes

1

Description
dry socket syndrome Incidence
Timepoint
1,3 And 7 days after the intervention on both the intervention and control sides.
Method of measurement
Evaluation through clinical observation by an oral and maxillofacial surgeon

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All patients underwent mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures was the same, a buccal flap with distobuccal releasing, along with a sulcular incision to the mesial of the seventh tooth. After anesthesia, incision, and flap removal, a portion of the bone covering the tooth will be removed with a surgical bur. After sectioning the tooth and removing it, the area on the intervention side is rinsed and the socket will be filled with one piece of Hemospan gel foam soaked with one drop of eugenol (manufactured by Golchai Company). Then, it is sutured using 3/0 chromic thread and a 26mm needle, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of the infectious agent, all patients will be prescribed Amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours to control possible pain. The patient is asked to do the following in the first 24 to 48 hours: 1- Consume cold foods and liquids such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not consume hot or chewy foods. 3- Avoid brushing the area where the tooth was extracted. 4- Avoid smoking and do not spit (spit) your saliva. 5- Avoid irritating the area where the tooth was extracted with your hands or tongue. 6- Avoid heavy exercise and physical work and prioritize rest. One day after surgery, normal saline solution should be used as a mouthwash at least five times daily for one week. One day, three days, and seven days after the extraction of the impacted third molar, the patient is contacted for clinical assessment of dry socket or absence of dry socket.
Category
Prevention

2

Description
Control Group: All patients undergo surgical extraction of the lower third molar by the same surgeon. The type of incision is the same in all procedures: a buccal flap with a distobuccal releasing incision, along with a sulcular incision extending to the mesial of the second molar. After administering anesthesia, making the incision, and reflecting the flap, a surgical bur is used to remove part of the bone covering the tooth. After sectioning and removing the tooth, the control site is irrigated and sutured using 3/0 chromic gut suture with a 26 mm needle. A sterile gauze is then placed at the site for 30 minutes. To better control and eliminate the effect of infection, all patients are prescribed amoxicillin 250 mg capsules every 8 hours and ibuprofen 500 mg tablets every 6 hours for pain control. Patients are instructed to follow postoperative care guidelines during the first 24 to 48 hours.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Medical Sciences - Faculty of Dentistry, Tehran branch
Full name of responsible person
Hassan Mesgari
Street address
No. 9, Pasdaran St., Nistan 9th
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
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
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Mesgari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., Nistan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
kmesgari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niyayesh Sadat Mirjafari
Position
Student of general dentistry
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit3, No3, gharbi8 ,Masjed St, Ghanat kowsar, Tehranpars
City
Tehran
Province
Tehran
Postal code
1689859361
Phone
+98 21 7736 2969
Email
niyayeshmirjafari@gmail.com

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
Undecided - It is not yet known if there will be 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
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