Objectives :Evaluation of Clinical and Radiographic success rate of Lesion Sterilization and Tissue Repair in non vital primary molars
Design : Single blind , Randomized , with control
Method:Clinical and radiographic signs of samples were recorded before intervention.Conventional pulpectomy was done for 25 teeth(control group). A mixture of 3mix Ciprofloxacin, Metronidazole and Minocycline was placed on the floor of the pulp chamber covering the root canal orifices(25 teeth). All the teeth were restored with stainless steel crowns. Post operative clinical and radiographic evaluation was done after 2,6 and 12 months.
Participants: Healthy children, visiting Dept. of Pediatric ,Mashhad dental school,
aged between 4 – 8 years
Inclusion criteria : Healthy children who were having 50 infected primary teeth
Exclusion criteria:children with systemic and immunosuppressed diseases
Intervention:using the 3 Mix Antibiotic paste on the floor of the pulp chamber
Main outcome variables :No clinical symptoms such as pain on percussion, history of swelling, or sinus tracts, remission of periradicular radiolucent lesion- no progress of lesion- no internal and external resorption
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112615558N1
Registration date:2016-07-03, 1395/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-03, 1395/04/13
Registrant information
Name
Homa Noorollahian
Name of organization / entity
Mashhad University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 51 3766 5343
Email address
noorollahianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad university of medical sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clinical and Radiographic success rate of Lesion Sterilization and Tissue Repair in non vital primary molars : a Clinical Trial
Public title
root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children with no systemic disease;
mandibular second primary molar tooth with periradicular radiolucency
Exclusion criteria:
children with systemic and immunosuppressed diseases and sensitive to antibiotic drugs;
hyperemic pulp
Age
From 4 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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
ethical commity of Mashhad University of Medical Sciences
Street address
Vice chancellor for research , Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.mums.sd.REC.1394.95
Health conditions studied
1
Description of health condition studied
pulpectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
clinical success
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
examination and observation, expression by pateint
2
Description
radiographic success
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
radiographic feature
Secondary outcomes
1
Description
pain
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
expression by patient
2
Description
fistula
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
examination and observation
3
Description
abscess
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
examination and observation
4
Description
tenderness to percussion
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
examination and observation
5
Description
new radiolucent lesion
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
radiographic feature
6
Description
change in primary lesion
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
radiographic feature
7
Description
internal or external resorption
Timepoint
2 and 6 and 12 months after intervention
Method of measurement
radiographic feature
Intervention groups
1
Description
]ntervention:
pulp therapy with 3 Mix Antibiotic paste,
Ciprofloxacin, Metronidazole and Minocycline,
volume ratio 1:3:3 respectively,
once utilization
Category
Treatment - Other
2
Description
Control:
standard pulpectomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad dental school
Full name of responsible person
Noorollahian Homa. Associate Professor of Pediatric Dentistry, Oral & Maxillofacial Diseases Researc
Street address
department of pedodontics,Mashhad dental school,Vakil Abad Boulevared
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad university of medical sciences
Full name of responsible person
Homa Noorollahian
Street address
Mashhad dental school, Vakil Abad Boulevard
City
Mashhad
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 of Mashhad 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
Mashhad dental school
Full name of responsible person
Homa Noorollahian
Position
Pedodontist,Associate Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Vakil Abad Boulvared
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
noorollahianh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad dental school
Full name of responsible person
Homa Noorollahian
Position
Pedodontist
Other areas of specialty/work
Street address
Vakil Abad Boulevared
City
Mashhad
Postal code
Phone
+98 915 557 7184
Fax
Email
noorollahianh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Dental School
Full name of responsible person
Homa Noorollahian
Position
Pedodontist,Associate Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Vakil Abad
City
Mashhad
Postal code
Phone
+98 915 557 7184
Fax
Email
noorollahianh@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)