Evaluation of clinical and radiographic success of pulpotomy in primary molars restored with glass ionomer- crown: A double-blind randomized clinical trial
Stainless steel crowns (SSCs) are treatment of choice subsequent to pulpotomy of primary molars. Despite durability of SSCs, due to prefabricated entity of crowns and their lack of accuracy at the margins, they cannot provide adequate seal. The aim of present study is to evaluate the clinical and radiographic success rate of pulpotomy in primary molars restored with glass ionomer- crown. In this double-blind randomized clinical trial, 55 children between 4-8 years old will participate. Inclusion criteria are requiring pulpotomy of mandibular primary second molars, complete physical and mental health, located in the positive or definitely positive classification of Frankle during pretreatment behavioral assessment, existence of enough crown tissue to repair, having nearly the same crown destruction on both sides. Any known allergy to medication or anesthetic solution and any emergency situation or tooth pain with pulp-origin are considered as exclusion criteria. Slit mouth design will be used in this study, in a way that each child will operate as a self-control and they will be randomly assigned, by the toss of a coin, to receive either crown restoration using crown-only or glass-ionomer crown. The time interval between two visits will be a week. In the second session, the child will receive the restoration not previously used. Pulpotomy and crown restoration of each tooth will be performed in a single session by one experienced pedodontist. Clinical and radiographic success will be recorded for each tooth at 6 months postoperatively according to criteria defined for successful clinical and radiographic treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609226105N6
Registration date:2016-11-14, 1395/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Nahid Ramazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 6706
Email address
ramazani77@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Zahedan University of Medical Sciences
Expected recruitment start date
2016-12-29, 1395/10/09
Expected recruitment end date
2017-03-25, 1396/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and radiographic success of pulpotomy in primary molars restored with glass ionomer- crown: A double-blind randomized clinical trial
Public title
Clinical and radiographic success of pulpotomy in primary molars restored with glass ionomer- crown
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Children between 4-8 years old, require pulpotomy in the primary mandibular second molars, having complete physical and mental health, located in the positive or definitely positive classification of Frankle during behavioral pretreatment assessment, existence of enough crown tissue to repair, nearly the same crown destruction on molars of both sides .
Exclusion criteria :Any known allergy to medication or anesthetic solution, any emergency situation or tooth pain with pulp-origin .
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Science
Street address
Zahedan, Persian Gulf Blvd., College, resistance Research and Technology
City
Zahedan
Postal code
9816743463
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IR.ZAUMS.REC.1395.41
Health conditions studied
1
Description of health condition studied
Dental Caries
ICD-10 code
B99-B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
clinical success
Timepoint
6 months after intervention 1 and 2
Method of measurement
using described criteria of successful clinical treatment including no swelling, tenderness to percussion, tenderness to palpation, mobility, fistula and abscess.
Secondary outcomes
1
Description
radiographic success
Timepoint
6 months after intervention 1 and 2
Method of measurement
using described criteria of successful radiographic treatment including no PDL widening, loss of lamina dura, radiolucency of furcation, internal or external root resorption, supporting bone destruction, pre apical radiolucency
Intervention groups
1
Description
Intervention 1
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) for 60 seconds, administration mandibular block anesthesia by delivering 1 mL of lidocaine 2% with epinephrine 1:80000 (Psocaine-E, Darou Pakhsh IND. CO Iran) within 1.5 minutes, rubber dam isolation, caries removal, access cavity preparation with high speed hand piece using water spray, coronal pulp excision using a sharp spoon excavator, rinsing with 5 mL normal saline (Darou Pakhsh IND. CO, Iran) bleeding control and establishing hemostasis with light pressure applying by cotton pellet for 5 minutes, fixing pulp stumps with 1/5 dilution Buckley formocrezole solution (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) for 1 minutes, placing fast setting zinc oxide eugenole (Zoliran, Golchadent CO, Iran) a pulp dressing material, restoring tooth crown at the same appointment by stainless steel crown (3M/ ESPE. St. Paul MN, USA) using luting glass ionomer cement (GC America, Inc., Alsip, IL, USA).
Category
Other
2
Description
مداخله 2
اعمال ژل بي حسي موضعي (TOPEX, Sultan Healthcare IND. CO, USA) به مدت 60 ثانيه، انجام بي حسي بلوک منديبل با تزريق 1 ميلي ليتر از محلول ليدوکائين 2% با اپي نفرين 80000/1 (Persocaine-E, Darou Pakhsh IND. CO, Iran) طي زمان 5/1 دقيقه، ایزولاسیون با رابردم، حذف پوسیدگی، تهیه حفره دسترسی با توربین با سرعت بالا و اسپری آب، قطع پالپ تاجی با اکسکاواتور قاشقی تیز، شستشو با 5 میلی لیتر نرمال سالین (Darou Pakhsh IND. CO, Iran)،کنترل خونریزی و ایجاد هموستاز با فشار ملایم گلوله پنبه به مدت 5 دقیقه، فیکس کردن پالپ ناحیه اریفیس با محلول فرموکرزول باکلی (Buckley’s FormoCresol® SultanHealthcare, Hackensack, NJ) با رقت یک پنجم به مدت 1 دقیقه، قرار دادن سمان زینک اکساید اوژنول زود سخت شونده (Zoliran, Golchadent CO, Iran) بعنوان ماده پوشاننده پالپ، ترمیم تاج در همان جلسه با استفاده از گلاس آینومر ترمیمی (GC America, Inc., Alsip, IL, USA) به عنوان ترمیم بازسازی تاج، قرار دادن روکش استینلس استیل (3M/ ESPE. St. Paul MN, USA) با استفاده از سمان گلاس آینومر لوتینگ (GC America, Inc., Alsip, IL, USA)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental School
Full name of responsible person
Nahid Ramazani
Street address
Azadegan Avenue
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Zahedan University of Medical Sciences
Full name of responsible person
Hushang Rafighdoost
Street address
Daneshgah street, Zahedan
City
9817699691
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 and Technology of Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Nahid Ramazani
Position
Pediatrician / Associate Professor
Other areas of specialty/work
Street address
Azadegan avenue
City
9817699691
Postal code
9817699691
Phone
+98 54 3341 4005
Fax
Email
ramazani_nahid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Nahid Ramazani
Position
Associate Professor
Other areas of specialty/work
Street address
School of Dentistry, Department of Pediatrics
City
Zahedan
Postal code
9817699693
Phone
+98 54 3341 4005
Fax
Email
ramazani77@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)