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Trial registered on ANZCTR


Registration number
ACTRN12621000493842
Ethics application status
Approved
Date submitted
11/03/2020
Date registered
28/04/2021
Date last updated
28/04/2021
Date data sharing statement initially provided
28/04/2021
Date results provided
28/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biodentine as an apical plug in immature permanent molars
Scientific title
Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars
(Randomized controlled clinical and radiographic trial)
Secondary ID [1] 300773 0
none
Universal Trial Number (UTN)
U1111-1249-5941
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
apical lesions 316623 0
Condition category
Condition code
Oral and Gastrointestinal 314858 314858 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 teeth treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher.
Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by means of a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit.
Biodentine plug Group (performed in a single clinic visit of approximately 45 minutes):
Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan).
The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
Patients of both groups will be recalled for radiographical examinations after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be taken using a paralleling technique with a film holder (Hawe Super-Bite; Kerr Hawe SA, Bioggio, Switzerland) by a digital radiographic system at every recall visits. All digital radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA).The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using “Image J” program and scored the sizes in both groups blindly and independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.
Intervention code [1] 317098 0
Treatment: Other
Comparator / control treatment
MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes):
MTA will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the MTA plugs will be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next day, under local anesthesia and rubber dam isolation, the temporary filling and the wet cotton pellet will be removed and the setting of MTA will be detected gently with #40 k-file (Mani, INK, Japan).
The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
Patients of both groups will be recalled for radiographical examinations after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be taken using a paralleling technique with a film holder (Hawe Super-Bite; Kerr Hawe SA, Bioggio, Switzerland) by a digital radiographic system at every recall visits. All digital radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA).The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using “Image J” program and scored the sizes in both groups blindly and independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.
Control group
Active

Outcomes
Primary outcome [1] 323200 0
radiographic success: apical lesion size reduction during the following up sessions (1,3,6,12 months post-intervention)
Timepoint [1] 323200 0
1 month (primary timepoint), 3 months, 6 and 12 months post-intervention
Secondary outcome [1] 381167 0
Nil
Timepoint [1] 381167 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria will be as the following: cooperative children without any systemic disease or compromised immune status, and who had a first immature mandibular molar with at least one canal sized #60 and more and had an apical lesion.
Minimum age
8 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss), molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external), and molars that had previous endodontic treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2020
Date of last participant enrolment
Anticipated
Actual
3/03/2020
Date of last data collection
Anticipated
Actual
4/04/2021
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 22435 0
Syrian Arab Republic
State/province [1] 22435 0
Damascus

Funding & Sponsors
Funding source category [1] 305231 0
University
Name [1] 305231 0
Damascus university
Country [1] 305231 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus university
Address
Faculty of dentistry, Damascus university, Al-Mazzeh St, Damascus University PO Box 30621 Syrian Arab republic
Country
Syrian Arab Republic
Secondary sponsor category [1] 305589 0
None
Name [1] 305589 0
none
Address [1] 305589 0
none
Country [1] 305589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305577 0
Ethical and Scientific Committee of dental research of Damascus University
Ethics committee address [1] 305577 0
Ethics committee country [1] 305577 0
Syrian Arab Republic
Date submitted for ethics approval [1] 305577 0
03/03/2020
Approval date [1] 305577 0
04/03/2020
Ethics approval number [1] 305577 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100834 0
Dr Yasser Alsayed Tolibah
Address 100834 0
Faculty of dentistry, Damascus university, Al-Mazzeh St, Damascus University PO Box 30621 Syrian Arab republic
Country 100834 0
Syrian Arab Republic
Phone 100834 0
+963988812044
Fax 100834 0
Email 100834 0
firedragoon1994@hotmail.com
Contact person for public queries
Name 100835 0
Yasser Alsayed Tolibah
Address 100835 0
Faculty of dentistry, Damascus university, Al-Mazzeh St, Damascus University PO Box 30621 Syrian Arab republic
Country 100835 0
Syrian Arab Republic
Phone 100835 0
+963988812044
Fax 100835 0
Email 100835 0
firedragoon1994@hotmail.com
Contact person for scientific queries
Name 100836 0
Yasser Alsayed Tolibah
Address 100836 0
Faculty of dentistry, Damascus university, Al-Mazzeh St, Damascus University PO Box 30621 Syrian Arab republic
Country 100836 0
Syrian Arab Republic
Phone 100836 0
+963988812044
Fax 100836 0
Email 100836 0
firedragoon1994@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
it is private information, the parents of children asked me to not share their information


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Children - MDPI 379444-(Uploaded-14-10-2023-01-12-51)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.