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Clinical and radiographic study to compare the effectiveness of pulpotomy on primary molars using diode laser or mineral trioxide aggregate

Evaluation of the effectiveness of pulpotomy on primary molars using diode laser vs. mineral trioxide aggregate (MTA) in children: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000425796
Enrollment
40
Registered
2022-03-14
Start date
2018-12-02
Completion date
2020-01-02
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 an

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.

Sponsors

University of Damascus
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 8 Years
Healthy volunteers
No

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.

Exclusion criteria

uncooperative patients, children more than 8years and less than 6years History of unprovoked tooth ache Pathologic Mobility Inter-radicular bone loss

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026