Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12622000425796
Ethics application status
Approved
Date submitted
12/10/2021
Date registered
14/03/2022
Date last updated
14/03/2022
Date data sharing statement initially provided
14/03/2022
Date results provided
14/03/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Clinical and radiographic study to compare the effectiveness of pulpotomy on primary molars using diode laser or mineral trioxide aggregate
Query!
Scientific title
Evaluation of the effectiveness of pulpotomy on primary molars using diode laser vs. mineral trioxide aggregate (MTA) in children: a randomised controlled trial
Query!
Secondary ID [1]
305527
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1270-3189
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
pulpotomy for primary molars
323918
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
321432
321432
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
pulpotomy of primary teeth with diode laser
20 patients (10 females and 10 males) with ages ranging between 6-8 years old were recruited from the Department of Pediatrics, University of Damascus Dental School,
With respect to the use of a Class IV laser, a controlled area was defined, to allow the safe use of the laser during treatment. Within this area, all measures were adopted to protect the patient and clinical staff, including appropriate eyewear protection, deployment of warning signs and test fire of the laser prior to treatment. Additionally, the laser emission parameters were checked, using a power meter. The first step in the treatment of the teeth during this trial was local or regional anesthesia using lidocaine 2% with 1/100,000 epinephrine (LignospanSpecial; Septodont, Kent, England). In each case, rubber dam was applied to the tooth for isolation. Before opening the pulp chamber, complete removal of the dental caries was achieved using a high-speed handpiece, allowing the removal of the roof of the pulp chamber. The coronal pulp contents were removed using a large spherical bur with a low-speed handpiece. After that, washing of the pulp chamber was done with saline solution and hemostasis achieved by applying a wet cotton ball for 3-5 minutes. In the test group, the canal orifice of each root was exposed to the diode laser irradiation (Fotonaâ„¢ Fotona XD-2 diode laser, Fotona dd, Slovenia), using the following parameters:
Wavelength: 810nm
Fiber diameter: 400µm
Average Power: 1.5 Watts
Energy per pulse 50mj
Frequency 10 Hz
Exposure time: 10 Secs
Energy density: 79.58 J/sq.cm
Power density: 795.77 W/sq.cm
Following this, a layer of fortified zinc oxide and eugenol (IRM) was applied . treatment was completed by putting a glass ionomer restoration (Medicem, Promedica; Germany), preparing the tooth, and luting an appropriate stainless steel crown (3M ESPE, St Paul, MN, USA).
the overall duration of the intervention procedure was 45 min.
At the baseline, clinical and radiological evaluations were recorded. Observation of the treated teeth was carried out after 3,6, and 12 months using the same records.
The pulpal response toward different pulpal medicament was obtained and analyzed for relative success and failure rates with clinical and radiological evidence by two independent examiners who were blinded for the cases which they were asked to examine. Clinical success was approved when the following criteria were observed: (a) there was no spontaneous or excited pain, (b) presence of healthy soft tissue, i.e. there is no gingival redness or fistula associated with the treated tooth, (c) natural movement of the tooth, and (d) absence of sensitivity to percussion. Radiological success was approved when the following criteria were observed: (i) no periapical translucency, (ii) no translucency in the furcation area, and (iii) no internal or external root resorption.
Query!
Intervention code [1]
321926
0
Treatment: Devices
Query!
Comparator / control treatment
pulpotomy of primary teeth with MTA
20 patients (10 females and 10 males) with ages ranging between 6-8 years old were recruited from the Department of Pediatrics, University of Damascus Dental School,
The first step in the treatment of the teeth during this trial was local or regional anesthesia using lidocaine 2% with 1/100,000 epinephrine (LignospanSpecial; Septodont, Kent, England). In each case, rubber dam was applied to the tooth for isolation. Before opening the pulp chamber, complete removal of the dental caries was achieved using a high-speed handpiece, allowing the removal of the roof of the pulp chamber. The coronal pulp contents were removed using a large spherical bur with a low-speed handpiece. After that, washing of the pulp chamber was done with saline solution and hemostasis achieved by applying a wet cotton ball for 3-5 minutes., MTA (Maillefer, Dentsply, Switzerland) was applied after hemostasis had been achieved.treatment was completed by putting a glass ionomer restoration (Medicem, Promedica; Germany), preparing the tooth, and luting an appropriate stainless steel crown (3M ESPE, St Paul, MN, USA).
the overall duration of the intervention procedure was 35 min.
At the baseline, clinical and radiological evaluations were recorded. Observation of the treated teeth was carried out after 3,6, and 12 months using the same records.
The pulpal response toward different pulpal medicament was obtained and analyzed for relative success and failure rates with clinical and radiological evidence by two independent examiners who were blinded for the cases which they were asked to examine. Clinical success was approved when the following criteria were observed: (a) there was no spontaneous or excited pain, (b) presence of healthy soft tissue, i.e. there is no gingival redness or fistula associated with the treated tooth, (c) natural movement of the tooth, and (d) absence of sensitivity to percussion. Radiological success was approved when the following criteria were observed: (i) no periapical translucency, (ii) no translucency in the furcation area, and (iii) no internal or external root resorption.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
329212
0
Primary outcome: clinical success of the pulpotomy...
Clinical success is achieved when the Dean 2016 criteria are met
(a) there was no spontaneous or excited pain, (b) presence of healthy soft tissue, i.e. there is no gingival redness or fistula associated with the treated tooth, (c) natural movement of the tooth, and (d) absence of sensitivity to percussion.
The probe is examined to determine the health of tissues and the presence or absence of a fistula. The presence of pain is determined by questioning the patient about the symptoms accompanying the treatment, and the movement is examined by forceps.
Query!
Assessment method [1]
329212
0
Query!
Timepoint [1]
329212
0
3 months after pulpotomy
Query!
Secondary outcome [1]
405660
0
Secondary outcome: radiological success of the treatment using periapical x-rays.
Radiological success defined as a composite of: (i) no periapical translucency, (ii) no translucency in the furcation area, and (iii) no internal or external root resorption. Assessed using periapical x-rays."
Query!
Assessment method [1]
405660
0
Query!
Timepoint [1]
405660
0
after pulpotomy directly
Query!
Eligibility
Key inclusion criteria
(1) healthy, cooperative patients, do not suffer from a pathological condition that prevents the pulpal treatment
(2) had one molar with an indication for pulpotomy with clinical and\or radiological symptoms like deep caries involving one or two surfaces of the tooth, physiological root resorption that does not exceed one-third of it.
(3) Absence of clinical signs and necrotic pulp which is: excessive movement, sensitivity on percussion, fistula in the tooth adjacent to the treated tooth, pus drainage from the crevicular gingiva, and spontaneous pain at night
(4) The absence of radiological signs of tooth death like radial translucency around the apex or at the roots furcation, pathological external root absorption in addition to internal absorption, and signs of canal calcification before treatment.
Query!
Minimum age
6
Years
Query!
Query!
Maximum age
8
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
uncooperative patients,
children more than 8years and less than 6years
History of unprovoked tooth ache
Pathologic Mobility
Inter-radicular bone loss
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
The sample size was calculated using Minitab Version 17 (Minitab Inc., State College, Pennsylvania, USA) With an alpha level of 0.05 and a power of 80%. Therefore, the sample required (40) primary molars.
The data were analyzed using SPSS version 20 (IBM Corporation., Chicago, IL, USA). The Fisher's exact test was used to compare clinical and radiological success rates between the MTA and laser pulpotomy technique at each of the observation period. Cochran Q test was also used to compare the clinical and radiographic success of both MTA and diode lasers during the three observation periods
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
2/01/2020
Query!
Date of last data collection
Anticipated
Query!
Actual
6/05/2020
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
40
Query!
Recruitment outside Australia
Country [1]
24194
0
Syrian Arab Republic
Query!
State/province [1]
24194
0
damascus
Query!
Funding & Sponsors
Funding source category [1]
309895
0
University
Query!
Name [1]
309895
0
University of Damascus
Query!
Address [1]
309895
0
Department of pediatric dentistry , University of Damascus Dental School, Syrian Arab Republic,Damascus ,Mazza Autoustrad
Query!
Country [1]
309895
0
Syrian Arab Republic
Query!
Primary sponsor type
University
Query!
Name
University of Damascus
Query!
Address
Syrian Arab Republic,Damascus ,Mazza Autoustrad
Query!
Country
Syrian Arab Republic
Query!
Secondary sponsor category [1]
310924
0
University
Query!
Name [1]
310924
0
University of Damascus
Query!
Address [1]
310924
0
Syrian Arab Republic,Damascus ,Mazza Autoustrad
Query!
Country [1]
310924
0
Syrian Arab Republic
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
309619
0
Damascus university
Query!
Ethics committee address [1]
309619
0
Department of Pediatric dentistry, University of Damascus Dental school Damascus,Syria
Query!
Ethics committee country [1]
309619
0
Syrian Arab Republic
Query!
Date submitted for ethics approval [1]
309619
0
02/01/2018
Query!
Approval date [1]
309619
0
12/02/2018
Query!
Ethics approval number [1]
309619
0
1133
Query!
Summary
Brief summary
A single centered, 2-arm parallel-group randomized controlled clinical trial was conducted in the Department of Pediatric dentistry, University of Damascus Dental school. The study protocol was reviewed by the Local Ethics Committee at the University of Damascus Dental School, Syria. The formal approval was obtained before the recruitment process began, the ethical approval reference number (1133). Introduction: Pulpotomy is the most common treatment used for carious primary molars to keep these teeth functional until their normal fallout time. Aim of the study: The aim of this study was to compare the clinical and radiological success of vital pulpotomy in primary teeth using a 810nm diode laser as adjunct and MTA. Materials and methods: 40 primary molars were selected from children aged (6-8 years). The teeth were divided randomly into two groups. Twenty primary molars were treated using laser pulpotomy. The other twenty molars were treated using MTA pulpotomy. Each vital pulpotomy treatment was carried out using rubber dam. Either MTA or laser application followed successful pulpal hemostasis. Each restoration was completed with IRM and GIC and coronal seal obtained using a stainless steel crown. Children were observed at baseline, 3, 6, and 12 months. We hypothesise that The use of laser in pulpotomy on primary molars, especially in children, provides a more calm and fear-free treatment at the dentist.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
114794
0
Dr ahmad owayed
Query!
Address
114794
0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Query!
Country
114794
0
Syrian Arab Republic
Query!
Phone
114794
0
+963992895149
Query!
Fax
114794
0
00963112124757.
Query!
Email
114794
0
[email protected]
Query!
Contact person for public queries
Name
114795
0
ahmad owayed
Query!
Address
114795
0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Query!
Country
114795
0
Syrian Arab Republic
Query!
Phone
114795
0
+963992895149
Query!
Fax
114795
0
00963112124757
Query!
Email
114795
0
[email protected]
Query!
Contact person for scientific queries
Name
114796
0
ahmad owayed
Query!
Address
114796
0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Query!
Country
114796
0
Syrian Arab Republic
Query!
Phone
114796
0
+963992895149
Query!
Fax
114796
0
00963112124757.
Query!
Email
114796
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
all of the individual participant data collected during the trial
Query!
When will data be available (start and end dates)?
available for 5 years after publication
Query!
Available to whom?
anyone who wishes to access it
Query!
Available for what types of analyses?
any purpose
Query!
How or where can data be obtained?
[email protected]
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
13514
Study protocol
[email protected]
13515
Clinical study report
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF