The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation & dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a claas I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its resembeles to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808132668N1
Registration date:2010-07-23, 1389/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-23, 1389/05/01
Registrant information
Name
Sepideh Banava
Name of organization / entity
Islamic Azad University, Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4570
Email address
dr.s.banava@dentaliau.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of common direct pulp capping treatments and single-visit with MTA on human pupal response (invivo)
Public title
Comparison of human pulpal response after pulpal exposure to common treatments and single-visit MTA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients aging from 10 to 16; 2- Patients that need to extract 4 premolars for orthidontic purposes; 3-the teeth should be free of caries and clinical symptoms; 4-Through thermal tests and radiographic examination absence of any pathology will be confirmed. Periapical radiographs demonstrating absence of any pathology, no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds. Pulp vitality will be ascertained with a digital pulp tester; 5- Absence of any systemayic disorder; 6- No consumption of drugs of any kind; 6-All patients and their parents need to sign a fully informed consent. Exclusion Criteria: 1-If any of the teeth shows caries, restoration, crack or hypocalcifacation; 2-presence of aperiapical pathosis; 3- Teeth that seem sensitive to cold, hot, percussion or pressure; 4- any systemayic disorder 5- consumption of drugs of any kind.
According to histological evaluation and ISO/DIS7405 we will give to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points. The specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge.
Secondary outcomes
1
Description
clinical signs like sensitivity to cold , heat , percussion , palpation , etc
Timepoint
weekly
Method of measurement
physical exam
Intervention groups
1
Description
application of MTA in second group and 24 hour interval before restoration
Category
Other
2
Description
pulpal exposurein all groups
Category
Treatment - Surgery
3
Description
application of Dycal in first group
Category
Other
4
Description
application of MTA in third group and 15 minute interval before restoration
Category
Other
5
Description
application of Multical in forth group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Islamic dental associatin of Iran
Full name of responsible person
Dr. S. Banava
Street address
No. 16 , Seventeenth street, Gandi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
personal
Full name of responsible person
Dr Sepideh Banava
Street address
No 4 , 10th Neyestan st, Pasdaaran st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personal
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
Islamic Azad University, Dental Branch
Full name of responsible person
Dr. Sepideh Banava
Position
Specialist in Restorative Dentistry, head of dental materials department, assitant professor