The aim of this study is to evaluate the effect of releasing incision after mandibular third molar surgery. In this clinical trial (Single blind), 20 patients according to inclusion criteria (age range 15-35 years, etc.) and exclusion (smoking, etc.) are selected. In each patient a triangular flap (conventional triangular or bayonet flap) in one side and an envelope flap on the other side is used. The side of the surgery to supply the flap is selected by random table and examiner is unaware of it. The time interval between the two surgeries is at least one month. Envelope flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then is extended from buccal gingival sulcus of second molar to mesiobuccal of second premolar. Triangular flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then it is extended in buccal gingival sulcus to mesiobuccal of second molar and finally connected to the releasing incision in mesiobuccal region with at least 1 cm length extension to buccal vestibular. Primary outcome: complication after surgery and secondary outcomes: Pain(measurement times:Daily up to a month after surgery), swelling, Trismus, Ecchymosis (measurement times: 3, 7, 14 days preoperatively and finally 1 month postoperatively) and duration of surgery (Since the beginning of surgery to the end of the last stitch)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506191760N42
Registration date:2015-07-06, 1394/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of releasing (relaxing) incision on the postoperative complication of mandibular third molar surgery
Public title
The effect of releasing (relaxing) incision on the postoperative complication of mandibular third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 15-35 years; Mandibular third molar teeth surgery candidates with Pell & Gregory and classified in categories 1 and 2 -A, B
Exclusion criteria:
Smoking;
Taking certain medications such as Corticosteroids or immunosuppressive drugs bisphosphonates; Illnesses such as diabetes, anemia and other debilitating diseases of the immune system; Haemorrhagic disease or taking anticoagulants; Background radiation in head and neck; pericoronitis or any pathological lesions associated with third molars is not growing; Significant injury periosteal flap envelope in
Age
From 15 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is Single blind. All patients underwent surgery by a fall, and assessments before and after surgery by colleagues(provided by flaps on both sides of the patient is not aware of) is done. In order to provide the flap, the choice of the surgery is done by random table and examine the person is unaware of it.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
4834
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01
ICD-10 code description
Embedded and impacted teeth
Primary outcomes
1
Description
Complications After Surgery
Timepoint
Daily up to a month after surgery
Method of measurement
Clinical
Secondary outcomes
1
Description
Pain Index
Timepoint
Daily up to a month after surgery
Method of measurement
Visual Analogue Scale
2
Description
Inflation
Timepoint
On the third, seventh, fourteenth, and one month after surgery
Method of measurement
Clinical
3
Description
The Lockjaw
Timepoint
On the third, seventh, fourteenth, and one month after surgery
Method of measurement
Clinical
4
Description
Ecchymosis
Timepoint
On the third, seventh, fourteenth, and one month after surgery
Method of measurement
Clinical
5
Description
Duration of surgery
Timepoint
Since the start of operation by the end of the last stitch
Method of measurement
Clinical
Intervention groups
1
Description
Intervention groups:
: triangular flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then it is extended in buccal gingival sulcus to mesiobuccal of 2nd molar and finally connected to the releasing incision in mesiobuccal region with at least 1 cm length extension to buccal vestibular. After reflecting full thickness flap, bone removal (Osteoctomy) and if sectioning of third molar (Odontomy) is required, done by using surgery bur. finally, after full restoration of homeostasis the flap is re-positioned to primary site and sutured.
Category
Treatment - Surgery
2
Description
Control groups:
Envelope flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then is extended from buccal gingival sulcus of second molar to mesiobuccal of second premolar.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental colleges of Babol
Full name of responsible person
Sara Ali Asghari
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
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
Dental colleges of Babol
Full name of responsible person
Sara Ali Asghari
Position
Dental students
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
s.aliasgharie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental colleges of Babol
Full name of responsible person
Dr. Ramin Frooghi
Position
Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
r.frooghi@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)