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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 information initially 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
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
Secondary ID [1] 305527 0
Nil known
Universal Trial Number (UTN)
U1111-1270-3189
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulpotomy for primary molars 323918 0
Condition category
Condition code
Oral and Gastrointestinal 321432 321432 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
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 (Fotona™ 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.
Intervention code [1] 321926 0
Treatment: Devices
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.
Control group
Active

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.
Timepoint [1] 329212 0
3 months after pulpotomy
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."
Timepoint [1] 405660 0
after pulpotomy directly

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.
Minimum age
6 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncooperative patients,
children more than 8years and less than 6years
History of unprovoked tooth ache
Pathologic Mobility
Inter-radicular bone loss

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation 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
Efficacy
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/12/2018
Date of last participant enrolment
Anticipated
Actual
2/01/2020
Date of last data collection
Anticipated
Actual
6/05/2020
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24194 0
Syrian Arab Republic
State/province [1] 24194 0
damascus

Funding & Sponsors
Funding source category [1] 309895 0
University
Name [1] 309895 0
University of Damascus
Country [1] 309895 0
Syrian Arab Republic
Primary sponsor type
University
Name
University of Damascus
Address
Syrian Arab Republic,Damascus ,Mazza Autoustrad
Country
Syrian Arab Republic
Secondary sponsor category [1] 310924 0
University
Name [1] 310924 0
University of Damascus
Address [1] 310924 0
Syrian Arab Republic,Damascus ,Mazza Autoustrad
Country [1] 310924 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309619 0
Damascus university
Ethics committee address [1] 309619 0
Department of Pediatric dentistry, University of Damascus Dental school Damascus,Syria
Ethics committee country [1] 309619 0
Syrian Arab Republic
Date submitted for ethics approval [1] 309619 0
02/01/2018
Approval date [1] 309619 0
12/02/2018
Ethics approval number [1] 309619 0
1133

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114794 0
Dr ahmad owayed
Address 114794 0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Country 114794 0
Syrian Arab Republic
Phone 114794 0
+963992895149
Fax 114794 0
00963112124757.
Email 114794 0
owayed003@gmail.com
Contact person for public queries
Name 114795 0
Dr ahmad owayed
Address 114795 0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Country 114795 0
Syrian Arab Republic
Phone 114795 0
+963992895149
Fax 114795 0
00963112124757
Email 114795 0
owayed003@gmail.com
Contact person for scientific queries
Name 114796 0
Dr ahmad owayed
Address 114796 0
Damascus university - pediatric dentistry department, Syrian Arab Republic, Damascus, Mazza Autoustrad
Country 114796 0
Syrian Arab Republic
Phone 114796 0
+963992895149
Fax 114796 0
00963112124757.
Email 114796 0
owayed003@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
owayed003@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13514Study protocol  owayed003@gmail.com
13515Clinical study report  owayed003@gmail.com



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 382934-(Uploaded-07-12-2021-07-00-37)-Basic results summary.doc

Documents added automatically
No additional documents have been identified.