Object:
Decreasing the recovery period after surgical removal of impacted third molar by decreasing the postoperative complications such as swelling, lockjaw…….
Inclusion/Exclusion criteria:
Any candidate for mandibular third molar removal via surgery enrolled in this study and the ones with history of systemic diseases were excluded.
Study sample and sample size:
Total 106 patients both male and female enrolled in this double blind study.
Intervention and time of study:
The Selected patients are randomly divided into two groups. Same Surgical procedure is carried out for all patients by a single surgeon but only we apply honey in some stages of surgery such as irrigation, suturing and dressing for control group.
This study is done in 2015-2016.
Primary outcomes:
Patients would be recalled 3rd and 10th days after surgery to evaluate the postoperative complications which are as follows: based on clinical examination (comparing 2 sides of patient's face/intraoral examination to check the presence of infection via foul-smelling odor and swelling In the gingiva around the surgical field, Difficulty opening the mouth or fever, dry socket) and visual analog scale and number of pain relief tablets (used for pain) we check the patient's mouth extension and measured maximum interincisal opening while opening his/her mouth to record presence of lockjaw.
Swelling is checked by tape measuring method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072923401N1
Registration date:2016-04-18, 1395/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-18, 1395/01/30
Registrant information
Name
Roya Safari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 8734333205092
Email address
r.safari@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Honey on surgical wound healing of impacted mandibular third molar surgery
Public title
Honey effect on third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion criteria: all patients with the history of:
Any systemic disease; any allergic to drugs or anesthetic agent used in our surgical procedure; smokers; and patients with poor oral hygiene followed by clinical examination.
inclusion criteria: any candidates for mandibular third molar removal via surgery based on orthopantograph image who were healthy proved by medical history.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Center of Kurdistan University of Medical Sciences
Street address
Research Center,Kurdistan University of Mecial Sciences, opposite of Shadi hotel, Pasdaran st, Sanandaj, Kurdestan, Iran.
City
Sanandaj
Postal code
6618634683
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
34/821536
Health conditions studied
1
Description of health condition studied
impacted third molar surgery
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
wound healing
Timepoint
2nd and 10th days after surgery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
pain
Timepoint
2nd and 10th days after surgery
Method of measurement
number of taken pain relief tablets
Intervention groups
1
Description
The Selected patients were randomly divided into two groups. Same Surgical procedure was carried out for all patients by single surgeon. They were anesthetized using Persocaine-E (lingocaeine 1:200000 with Adrenaline, made inDarupakhsh Company, Iran) via classical Inferior alveolar nerve block, lingual nerve block and long buccal nerve block. Full thickness incision was made to prepare modified triangle flap, tooth was sectioned, loosened and removed by elevator.
After extraction, curettage and simple alvoeloplasty was done plus irrigation with 20ml NaCl in control group and simple dressing
Category
Treatment - Drugs
2
Description
The Selected patients were randomly divided into two groups. Same Surgical procedure was carried out for all patients by single surgeon. They were anesthetized using Persocaine-E (lingocaeine 1:200000 with Adrenaline, made inDarupakhsh Company, Iran) via classical Inferior alveolar nerve block, lingual nerve block and long buccal nerve block. Full thickness incision was made to prepare modified triangle flap, tooth was sectioned, loosened and removed by elevator.
then irrigation with diluted honey with NACl and applying honey dressing
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arian Dental Clinic
Full name of responsible person
Ensi Kolyaei
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Pasdaran boulevard
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
oral surgery department
Full name of responsible person
Ensi Kolyaei
Position
student
Other areas of specialty/work
Street address
Pasdaran boulevard
City
Sanandaj
Postal code
Phone
+98 87 3323 5445
Fax
Email
nc.kolyaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
oral surgery department
Full name of responsible person
Ensi Kolyaei
Position
student
Other areas of specialty/work
Street address
Pasdaran boulevard
City
Sanandaj
Postal code
Phone
+98 87 3323 5445
Fax
Email
nc.kolyaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ensi Kolyaei
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
nc.kolyaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)