The main purpose during this study is evaluation of Pro root-MTA, Biodentine and Theracal in partial pulpotomy of human dental healthy pulp. Design of this study is single blind. Thirty intact maxillary and mandibular third molars will be used. The teeth will be divided into 3 experimental groups(10 in every group). Before cavity preparation, teeth will disinfected with 0.2% Chlorhexidine solution. After local anesthesia and rubber dam application, occlusal Class I cavities will prepare. Bleeding will be controlled with Saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sites. the teeth will be provisionally restored with Glass Inomer cement. Patients in all groups will return to the clinic for clinical examinations and extraction after 2 months. Inclusion criteria is age(18-32 years)؛ erupted third molar؛ closed apex؛ caries free؛ normal sign to vitality tests and exclusion criteria is external or internal resorptin؛ periapical lesion. Biodentin and Theracal are intervention groups and Pro root-MTA is control group.The main outcome measure is pulp health and dentin barrier formation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082420004N2
Registration date:2016-02-10, 1394/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-10, 1394/11/21
Registrant information
Name
Hengameh Bakhtiar
Name of organization / entity
Islamic Azad University of Tehran, faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 912 813 2267
Email address
h_bakhtiar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical, radiological and histological evaluation of Pro root-MTA, Biodentine and Theracal in partial pulpotomy of human dental healthy pulp.
Public title
Evaluation of Pro root-MTA, Biodentine and Theracal in partial pulpotomy of human dental healthy pulp.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age(18-32 years)؛ erupted third molar؛ closed apex؛ caries free؛ normal sign to vitality tests
Exclusion criteria: external or internal resorptin؛ periapical lesion
Age
From 18 years old to 32 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Moral Committee of Islamic Azad dental university of Tehran.
Street address
Azad dental school, #10 Neyestan, Pasdaran Ave, Tehran, Iran.
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
0821.P.166.5
Health conditions studied
1
Description of health condition studied
Vital pulp therapy.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulp health( Post Operative sensitivity and pain ).
Timepoint
After treatment, 1 weak later and before extraction.
Method of measurement
Vitality tests, cold test and EPT.
2
Description
Signs of periapical pathology.
Timepoint
Radiographs are taken before intervention and extraction.
Method of measurement
PA radiography.
Secondary outcomes
1
Description
Dentine barrier formation.
Timepoint
8 weeks after beginning treatment.
Method of measurement
Histologic examination after extraction.
Intervention groups
1
Description
In first group, Biodentin will be used for partial pulpotomy. Biodentin is new calcium silicate-based that is bioactive and non-toxic as demonstrated on human pulp cells. One single dose of liquid will be added to a capsule containing Biodentin and will be mixed for 30 seconds. Then a bulk of cement will be applied in the cavity and the setting time is 12 minutes.Then teeth will be filled with Glass Inomer.
Category
Treatment - Other
2
Description
In the second groupe, Theracal will be used for partial pulpotomy. Theracal is also a new light-cured resin-modified calcium silicate-filled base/liner material, which sets in 20 seconds. Theracal consists of a single paste that placing in 2mm layer. Then teeth will be filled with Glass Inomer.
Category
Treatment - Other
3
Description
Pro root-MTA will be used for partial pulpotomy in control group. it is a water based_material compound with bismuth oxide, tricalcium and dicalcium silicate and tricalcium aluminate. Open a pouch of 0.5 mg pro_root MTA and dispense onto a mixing pad then pull of a Pro root_MTA liquid ampoule and gradually mix the liquid into the cement for about 1 minute till make them into a creamy consistency material. Then teeth will be filled with Glass Inomer.