purpose of the study: evaluate the clinical and radiographic success rate of Miniature pulpotomy with 3 different techniques in primary second mandibular molars
Design: Randomized, Single Blind, without placebo, one center, Phase 3
Population:
Inclusion Criteria : 4-7 year-old ; healthy and cooperative children ; with deep carious primary second molars
Exclusion Criteria: spontaneous pain ; swelling ; tenderness ; sinus tract ; excessive bleeding from the exposure site ; pathologic mobility ; no exposure ; pathologic root resorption ; periapical or furcation bone radiolucency ; PDL widening ; physiologic root resorption more than 1/3
Sample Size: 63 mandibular primary second molars
Intervention: In this trial, 63 mandibular primary second molars in 4-7 year-old children will randomly undergo Miniature pulpotomy with MTA, MTA-Low Level Diode Laser Therapy and MTA-High Level Diode Laser Therapy. Then restoration with stainless steel crowns(SSCs) will be done. Following the treatment, the teeth will monitor for clinical and radiographic evaluation after 6 and 12 months.
Time:6 and 12 months follow-up
Outcome:clinical and radiographic success or failure of treatment will define with observation and check list
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100524373N1
Registration date:2015-11-13, 1394/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Sima Changiz
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 6362
Email address
changizs921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences- Dental School
Grant of Responsible Party
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Clinical and Radiographic outcomes of 3 different techniques of Miniature Pulpotomy in Primary second Molars in 4-7 year-old children
Public title
Miniature pulpotomy with 3 different techniques in primary second molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 4-7 year-old ; healthy and cooperative children ; with deep carious primary second molars
Exclusion Criteria: spontaneous pain ;swelling ; tenderness ; sinus tract ; excessive bleeding from the exposure site ; pathologic mobility ; no exposure ; pathologic root resorption ; periapical or furcation bone radiolucency ; PDL widening ; physiologic root resorption more than 1/3
Age
From 4 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
63
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
Mashhad University of Medical Sciences
Street address
Park Squre
City
Mashhad
Postal code
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
930913
Health conditions studied
1
Description of health condition studied
Pulpal Treatment in primary second molars
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
successful outcome of treatment as indicated by clinical signs
Timepoint
up to 12 months
Method of measurement
with observation and check list
Secondary outcomes
1
Description
successful radiographic outcome of treatmen
Timepoint
up to 12 months
Method of measurement
with observation of radiography and check list
Intervention groups
1
Description
Miniature Pulpotomy of primary second molars with MTA
Category
Treatment - Other
2
Description
Miniature Pulpotomy of primary second molars with Low Level Laser Therapy-MTA
Category
Treatment - Other
3
Description
Miniature Pulpotomy of primary second molars with High Level Laser Therapy-MTA
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School- Mashhad University of Medical Sciences
Full name of responsible person
Dr Masoumeh Ebrahimi- Dr Abbas Makarem
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Ebrahimi
Street address
Mellat Park Square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 university of medical sciences
Full name of responsible person
Masoumeh Ebrahimi
Position
Associate Proffessor
Other areas of specialty/work
Street address
Mellat Park Square
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
EbrahimiMa@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Ebrahimi
Position
Associate proffessor
Other areas of specialty/work
Street address
Mellat Park Square
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
EbrahimiMa@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sima Changiz
Position
Rezident of Pediatric Dentistry
Other areas of specialty/work
Street address
Mellat PArk Square
City
Mashhad
Postal code
Phone
00
Fax
Email
changizs921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)