The main purpose during this study is evaluation of Pro root-MTA and Retro root-MTA in partial pulpotomy of human dental healthy pulp.26 intact maxillary and mandibular third molars will be used. The teeth will be divided into 2 experimental groups (13 in every group). Before cavity preparation, teeth will be 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 ionomer cement. Patients in all groups will return back for clinical and radiological examinations and extraction after 2 months. Inclusion criteria are: age(18-32 years); erupted third molar; closed apex; caries free; normal sign to vitality tests and exclusion criteria are: external or internal resorption and peri apical lesion. Retro root-MTA is the intervention group 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:IRCT2016020420004N3
Registration date:2016-02-23, 1394/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-23, 1394/12/04
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 and Retro root-MTA in partial pulpotomy of human dental healthy pulp
Public title
Evaluation of Pro root-MTA and Retro root-MTA in partial pulpotomy of human dental healthy pulp
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between18-32 years old; erupted third molar; closed apex; caries free; normal sign to vitality tests. Exclusion criteria: external or internal resorptin; peri apical 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:
26
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
IA49.1
ICD-10 code description
Infection disease
Primary outcomes
1
Description
Pulp health(Post Operative sensitivity and pain )
Timepoint
After treatment,1 week later and before extraction
Method of measurement
Vitality test,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
Dentin barrier formation
Timepoint
Eight weeks after beginning treatment
Method of measurement
Histological examination after extraction
Intervention groups
1
Description
Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sites.
In group 1 the pulps and the surrounding dentins will be capped with Retro-MTA as an interventive group.Reto-MTA is a hydraulic bioceramic material for repair and vital pulp therapy. Retro-MTA is powder consisting of fine,hydrophilic particles that set in the presence of water and form a strong impermeable barrier.it contains hydraulic calcium zirconia complex as a contrast media.setting time is 150 seconds.it has no discoloration even in the blood contamination.it has no toxicity to cells in 48 hours.this means it is a ideal substance for vital pulp therapy.fast setting,no discoloration,no heavy metal,no cell toxicity,good handeling properties and economic price are some of sultaible properties of Retro-MTA.in vivo condition Ph is up to 12/5and down to 7.8-8 in 4 weeks.Ex vivo study shows it has the high potential for biomineralization. هی 0/3 gram Retro root-MTA powder with 3 drops of water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears.
The teeth will be provisionally restored with glass ionomer cement (Ketac Molar; 3M ESPE, Seefeld, Germany).
2 months later, patients will return back and after clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All the clinical procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Islamic Azad Dental university of Tehran.
Category
Treatment - Other
2
Description
Before the operative protocol, each tooth will be radiologically examined to exclude the presence of caries or periapical pathology. A standardized operative procedure is followed in both experimental groups. Thermal testing (K€altespray; M&W Dental GmbH, B€udingen, Germany) will perform to assess pulp vitality. Before cavity preparation, teeth will mechanically be cleaned and disinfected with 0.2% chlorhexidine solution. After local anesthesia (Iran-Darou pakhsh) and rubber dam application, occlusal Class I cavities will prepare by using round sterile diamond burs at high speed under air-distillated water spray coolant. An exposure of approximately 1.2 mm in diameter will be made with round carbide burs (4 1.2 mm) under sterile saline cooling. New burs will be used during each operation. Bleeding will be controlled with saline irrigation, and a sterile cotton pellet is placed onto the pulp exposure sitesProRoot MTA(Dentsply-USA) is a water-based material which uses for apexification, repairing root perforations and As a pulp capping material.It sets in the presence of moisture. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.In group II exposed pulps and the surrounding dentins will be capped with Retro-MTA.0/3 gram Retro root-MTA powder with 3 drops of water will be mixed by a plastic spatula for 20 seconds until the shiny surface disappears. 2 months later, patients will return back and after clinical and radiographical examinations, the teeth will be extracted and sent to a talented pathologist for histological examinations.All procedures will be performed by one experienced operator (A.N.) in the Endodontic Department of Dental School.