According to the large number of third molar surgery and high incidence and prevalence of complications after this surgery and that there are many studies that confirmed the positive effects of an oily calcium hydroxide suspension on periodontal healing after surgical and non surgical treatments we decided to evaluation the effect of an oily calcium hydroxide suspension (osteora) on pain and complications after surgical removal of impacted third molar. Materials and Methods: This study will be conducted with double blinded sequential matched randomized clinical trial design on patient who will come to Surgical Department of Tehran Azad university of Medical Sciences and two private offices. All patients whom underwent this surgery will between 17-40 years old that have the indication for extracting wisdom tooth surgery; have bilateral third molar (in maxilla or mandible) and these teeth have the same criteria as in four point trauma rating scale and Pederson. Patients consciously agreed to this study and promising incorporation. Effect of OSTEORA will be evaluated on pain, healing, hemorrhage, dry socket and infection in different times. If this material have positive impact on pain, complications and healing after third molar surgery, could be alternative for various other drugs which have side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040717166N1
Registration date:2014-04-17, 1393/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Saifollah Hemmat
Name of organization / entity
Bandarabbas University of Medical Sciences, Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 76 1335 0573
Email address
hemmat.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
research center of azad dental university of tehran
Expected recruitment start date
2013-10-06, 1392/07/14
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of an oily calcium hydroxide suspension on pain and complications after surgical removal of impacted third molar
Public title
effect of an oily calcium hydroxide suspensin on complications after third molar surgery
Purpose
Prevention
Inclusion/Exclusion criteria
All patients whom underwent this surgery were between 17-40 years old that had the indication for exacting wisdom tooth surgery; had bilateral teeth (maxilla or mandible) and these teeth had the same criteria as in four point trauma rating scale and Pederson. Patients consciously agreed to cooperate with this study and promising incorporation.
patients will be excluded if: having acute or chronic pericoronitis; using drugs except the drugs which were considered in the study; their disinclination for evaluation; not filling out or handing the forms; having systemic problems; pregnancy; considered drug prohibition for the patient; having allergic history to the considered drug; having painful conditions in the mouth like having teeth with root canal therapy indication; having any algogenic condition in the body; having nervous system diseases; having a need for prophylaxis; patients using steroids, antidepressant, antibiotics, analgesics; having complications during surgery; inferior alveolar canal exposure; applying more traumatic pressure in one side; having the condition that four bony walls were not available for putting the material; condition were having same numbers of sutures were not possible; disability in suturing the flap completely.
Age
From 17 years old to 40 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
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
islamic azad university of medical sciences, dentistry faculty
Street address
no.4 , 10th neyestan, pasdaran street
City
tehran
Postal code
19486
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
13011
Health conditions studied
1
Description of health condition studied
impacted third molar
ICD-10 code
k01.1
ICD-10 code description
Embedded and impacted teeth
Primary outcomes
1
Description
pain
Timepoint
immediate,1,6,12,24,32,48,72 hours after surgery
Method of measurement
The amount of pain depending on VAS of pain
2
Description
healing
Timepoint
immadiate,3 and 7 days after surgery
Method of measurement
with healing scale
3
Description
dry socket
Timepoint
3-4 days after surgery
Method of measurement
inspection of signs and symptoms
4
Description
infection
Timepoint
3-7 days after surgery
Method of measurement
inspection of signs and symptoms
5
Description
bleeding
Timepoint
immediate,8-24 hours , 24-72 hours after surgery
Method of measurement
inspection of signs and symptoms
Secondary outcomes
empty
Intervention groups
1
Description
intervention: after surgical removal of tooth ,the socket was chosen randomized and it was filled with OCHS (OSTEORA® 0.5 ml) until it got overfilled
Category
Prevention
2
Description
control:after surgical removal of impacted third molar On the other side we just pretended to put it in the socket (control group) and the patient was convinced that we had put the material on the both sides
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
tehran azad university of medical sciences, dental faculty
Full name of responsible person
dr. saifollah hemmat
Street address
no.4 , 10th neyestan, pasdaran street
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reserch Center of Tehran azad university of medical sciences
Full name of responsible person
Naser Valayei
Street address
No.4 , 10th Neyestan, Pasdaran street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reserch Center of Tehran azad 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
tehran azad university of medical sciences, dental faculty
Full name of responsible person
dr. saifollah hemmat
Position
oral and maxillofacial surgen
Other areas of specialty/work
Street address
no. 4 , 10th neyestan, pasdaran street
City
tehran
Postal code
19486
Phone
+98 21 2256 4570
Fax
+98 21 2256 4573
Email
info@dfau.com
Web page address
www.dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
tehran azad university of medical sciences , dental faculty
Full name of responsible person
dr. saifollah hemmat
Position
oral and maxillofaial surgen
Other areas of specialty/work
Street address
no.4, 10th neyestan, pasdaran street
City
tehran
Postal code
19486
Phone
+98 21 2256 4570
Fax
+98 21 2256 4573
Email
info@dfau.com
Web page address
www.dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
tehran azad university f medical sciences, dental faculty
Full name of responsible person
dr. saifollah hemmat
Position
oral and maxillofacial surgeon
Other areas of specialty/work
Street address
no.4, 10th neyestan, pasdaran street
City
tehran
Postal code
19486
Phone
+98 21 2256 4570
Fax
+98 21 2256 4573
Email
info@dfau.com
Web page address
www.dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)