Protocol summary

Summary
The aim of this study was to see the effect of a 0.75% metronidazole gel on complications of problems after extraction of mandibular molar.Inclusion criteria was absent of local or systemic difficulties for teeth extraction, mandibular molar tooth that must be extracted.Symmetrical mandibular teeth in radiography that must be extracted. Exclusion criteria If teeth during extraction were broken or teeth need surgical extraction. Patients that use smoke or any drugs. This study was conducted on 20 males 20 to 30 years old during one year.For each patient two mandibular teeth were extracted. The 0.75% metronidazol gel was used in place of extracted teeth, as there was no material left in the other socket. After extraction the teeth, swelling, pain، dry socket was assessed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512195565N4
Registration date: 2016-01-13, 1394/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-13, 1394/10/23
Registrant information
Name
Ali Peimani
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0008
Email address
a_peymani@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
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
Survey effect of metronidazole 0.75% gel on complications after mandibular molar teeth extraction
Public title
Effect of metronidazole gel on socket tooth healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Absent of local or systemic difficulties for teeth extraction; Mandibular molar tooth that must be extracted; Symmetrical teeth in radiography; Patients between 20-30 years Exclusion criteria: If teeth during extraction were broken; If teeth need surgical extraction; Patients that use smoke or any drugs
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan university of medical scinces
Street address
Emam ali Avn., university central office
City
Rafsanjan
Postal code
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.RUMS.REC.1394.141

Health conditions studied

1

Description of health condition studied
Inflammation due to tooth extraction
ICD-10 code
Y56.0
ICD-10 code description
Local antifungal, anti-infective and anti-inflammatory drugs, not elsewhere classified

Primary outcomes

1

Description
dry socket
Timepoint
72 hours after tooth extraction
Method of measurement
Observation

2

Description
pain
Timepoint
6,12, 24 and 48 hours after extraction tooth
Method of measurement
VAS

3

Description
swelling
Timepoint
6,12, 24 and 48 hours after extraction tooth
Method of measurement
facial index in mm

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Metronidazole 0.75% gel immediately after tooth extraction
Category
Treatment - Drugs

2

Description
Control: Any drug did not put in the tooth socket
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan Dental School
Full name of responsible person
Dr Ali Peymani
Street address
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Hakimy
Street address
University Central Office- Imam Ali Avn.
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan university of Medical sciences
Full name of responsible person
Dr.ali peymani
Position
Maxillofacial surgeon and member of dental school
Other areas of specialty/work
Street address
Dental school- West Mofatteh Avn.
City
Rafsanjan
Postal code
Phone
+98 343428008
Fax
Email
a_peymani@rums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan university of Medical sciences
Full name of responsible person
Dr Ali Peymani
Position
Maxillofacial surgeon and member of dental school
Other areas of specialty/work
Street address
Dental school- West Mofatteh Avn.
City
Rafsanjan
Postal code
Phone
+98 343428008
Fax
Email
a_peymani@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr ali peymani
Position
Maxillofacial surgeon
Other areas of specialty/work
Street address
Dental School- West Mofatteh Avn.
City
Rafsanjan
Postal code
Phone
+98 34 3428 0008
Fax
Email
a_peymani@rums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...