Comparison of delay infection in envelope and three-corner flaps in impact mandibular third molar surgery in Tehran Azad Dental University and Shahid Beheshti University and Behfar Clinic and Ghazi Tabatabaee Clinic.
Design
The clinical trial study contains two parallel groups which are double blind randomized by using a four-segment block.
Settings and conduct
Subjects who have similar impacted teeth bilaterally will be undergo surgeries for removal them.Randomly , three corner flap will be used in a side and an envelope flap will be applied to another side. The prevalence of the delayed infection will be estimated in each side.
Participants/Inclusion and exclusion criteria
Including Criteria: People Having ASA1 Systemic Condition.Subjects are candidate for both Mandibular Impacted Third Molar Surgery.Both Impacted Teeth Must be In the Same Pell and Gregory Classification.Subjects' age Must Be Between 18 to 30 Years.
Exclusion Criteria: Patients with decayed second mandibular tooth which need a root canal therapy.Smoker patients.Patients who have pathologic lesion around impacted wisdom tooth.Patients with incapability of mouth opening over 35 millimeters.Patients with poor oral hygiene.Patients who have got mandible trauma.Patients who are not capable to come over for a follow-up session.Patients who do not use antibiotics and antiseptics by regular given order.
Intervention groups
The three corner flap sides
the envelope flap sides
Main outcome variables
Pain; swelling; redness; pus discharge 2 to 6 weeks after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210920052527N1
Registration date:2021-10-20, 1400/07/28
Registration timing:registered_while_recruiting
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
Mohammad Reza Soleimanpour Boroujeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4570
Email address
m.soleimanpour@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Delayed Infection in Envelope and Three-Corner Flaps in Impact Mandibular Third Molar Surgery, a Prospective Study
Public title
Delayed Infection in Two Types of Wisdom Tooth Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People Having ASA1 Systemic Condition
People Candidate for Both Mandibular Impacted Third Molar Surgery
Both Impacted Tooth Must be In Same Pell and Gregory Classification
Patient Age Must Be Between 18 to 30 Years.
Exclusion criteria:
Patients with decayed second mandibular tooth which needs a root canal therapy.
Smoker patients.
Patients who have got a pathologic lesion around impacted wisdom tooth.
Patients with incapability of mouth opening over 35 millimeters.
Patients with poor oral hygiene.
Patients who have got mandible trauma.
Patients who are not capable to come over for a follow-up session.
Patients who do not use antibiotics and antiseptics by regular given order.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
202
Randomization (investigator's opinion)
Randomized
Randomization description
Every 4 indicated patients who are referred to dental departments of Shahid Beheshti University, Tehran Azad University,Behfar clinic and Ghazi Tabatabaee for wisdom tooth removal surgery are planned to include in quadruple blocks. This block is actually a table of 2×2 which its columns title is name of flap and its raws title is the side of surgery. This blocks include side and type of the first surgery which was extracted from the table in line before: Right side and Three-corner flap, right side and envelope flap, left side and three-corner flap, and left side and envelope flap. These data would be given in 4 sealed pockets to the surgeon and surgeon would pick one of them. After that, surgeon will operate patient according to the selected data. Every 4 patient must undergo surgery according to one of these pockets.The other flap on the other side would be operated according to the picked pockets.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analyzer will not know about the inside of the pocket given to the surgeon.(However patients would be aware of the study. Also patients would find out which tooth undergoes operation.) Also the surgeon would not be informed about which sealed pockets would contain what information. The surgeon will pick up one of the sealed pockets randomly.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences.
Street address
No. 9, Arghavan Alley, North Behzad Bolevard, Second Abghari Street, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998666898
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.050
Health conditions studied
1
Description of health condition studied
--
ICD-10 code
---
ICD-10 code description
--
Primary outcomes
1
Description
Delayed infection after surgery with pain, redness, swelling, pus discharge and restriction of maximum mouth opening symptoms.
Timepoint
2 weeks after surgery, 4 weeks and 6 weeks.
Method of measurement
Clinical evaluation for detection of infection (redness, pain, swelling, pus discharge and restriction of maximum mouth opening)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a three-corner flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols.
Category
Treatment - Surgery
2
Description
Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a envelope flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department of Shahid Beheshti University
Full name of responsible person
Parisa Moradi
Street address
Dental School, Daneshjou Bolevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1998666898
Phone
+98 21 2680 2783
Email
p.moradi17@yahoo.com
2
Recruitment center
Name of recruitment center
Behfar Clinic
Full name of responsible person
Parisa Moradi
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
1998666898
Phone
+98 21 7781 3948
Email
p.moradi!7@yahoo.com
3
Recruitment center
Name of recruitment center
Ghazi Tabatabaee
Full name of responsible person
Parisa Moradi
Street address
Farrkhi Yazdi square, Pasdaran Avenue
City
Tehran
Province
Tehran
Postal code
1998666898
Phone
+98 21 2284 7081
Email
p.moradi17@yahoo.com
4
Recruitment center
Name of recruitment center
Dental Department, Azad Tehran University of Medical Sciences