Introduction: Impacted Third molar surgery is often associated with postoperative complications such as pain, swelling, trismus and dry socket. As the flap design is one of the factors that affect the severity of these unwanted effects, therefore, this study designed to evaluate the influence of modified triangular flap in comparison with envelop flap on dry socket, in patients reffering to the department of oral &maxillofacial surgery of Yazd dental school in 1392.
Materials and Methods :
This clinical-trial, double-blind, prospective study was accomplished on 30 patients (60 samples) referring to the oral and maxillofacial department of Yazd dental school in 1392 who were candidates for extraction of bilaterally impacted lower third molars with the same difficultly; no associated pathology; the plaque index score lower than 20%; no use of any antibiotics or anti-inflammatory drugs within 14 days before surgery and root formation between 1/3to 2/3. The patients with a history of systemic disease; pregnancy; milking period or a history of dry socket; deep bony impaction of lower third molars; smoking; use of oral contraceptive tablets and patients with immunocompromised state were excluded from the study. The influence of modified triangular flap and envelop flap on dry socket was evaluated and recorded in the seventh day after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052717863N2
Registration date:2014-06-17, 1393/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Sahebe Talebi Banizi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1825 2484
Email address
sahebetalebi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-06-30, 1392/04/09
Expected recruitment end date
2014-06-30, 1393/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two types of envelope and modified triangular flap in the prevention of dry socket after mandibular third molar surgery.
Public title
Evaluation of side effects of two types of flap after impacted mandinular third molar surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: bilateral impacted mandibular third molar teeth with equal location in the jaw; no associated pathology; the plaque index score lower than 20%; no use of any antibiotics or anti-inflammatory drugs within 14 days before surgery; root formation between 1/3to 2/3. Exclusion criteria: Patients with a history of systemic disease; pregnancy; milking period or a history of dry socket; deep bony impaction of lower third molars; poor oral hygiene; recent history of pericoronitis; ulcerative gingivitis or active infection associated with the extracted tooth; smoking; oral contraceptive tablet use and immunocompromised patients.
Age
From 18 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science
Street address
central organization,Shahid Bahonar square
City
Yazd
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
2926
Health conditions studied
1
Description of health condition studied
dry socket
ICD-10 code
K10.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
dry socket
Timepoint
after seven days
Method of measurement
clinical
Secondary outcomes
empty
Intervention groups
1
Description
In an intervention group,modified triangular flap was used the presence of dry socket was evaluated after 7 days from the surgery.
Category
Treatment - Surgery
2
Description
In a control group,modified triangular flap was used the presence of dry socket was evaluated after 7 days from the surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of oral and maxillofacial surgery of Shahid Sadoughi Yazd dental school
Full name of responsible person
Sahebe Talebi Banizi
Street address
Emam Reza Blv
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Fateme Ezoddini
Street address
Central Organization, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sahebe Talebi Banizi
Position
dental student
Other areas of specialty/work
Street address
dental school
City
Yazd
Postal code
Phone
+98 35 1825 2484
Fax
Email
talebi.sahebe@yahoo.com sahebetalebi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sahebe Talebi Banizi
Position
dental student
Other areas of specialty/work
Street address
dental school
City
Yazd
Postal code
Phone
+98 35 1825 2484
Fax
Email
talebi.sahebe@yahoo.com sahebetalebi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sahebe Talebi Banizi
Position
dental student
Other areas of specialty/work
Street address
dental school
City
Yazd
Postal code
Phone
+98 35 1825 2484
Fax
Email
talebi.sahebe@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)