Evaluation of Pulpotomy Success of Different Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-10-01

Brief Summary

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Considering the lack of data in the literature concerning the success of Er,Cr:YSGG laser in pulpotomy treatment of primary teeth, the present study aimed to compare this laser system with two different chemical hemostatic agents regarding its clinical and radiographic success.

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Detailed Description

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The study was carried on 65 patients (33 females and 32 males) with ages ranging between 5-9 years and having no systemic disease. Inclusion criteria were as follows; deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation, no soft tissue pathologies such as edema, fistula, abscess, mechanical exposure greater than pinpoint, carious exposure, suitability for restoration with stainless steel crowns, healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp. Only the mandibular primary molars were included in the study to evaluate the roots better radiologically. A single physician performed all patients' treatments. Following administration of local anesthesia, the teeth were isolated by a rubber dam. The carious enamel tissue was removed and the cavities were formed using a high-speed rotary instrument under water cooling. The carious dentin was removed using a low-speed rotary instrument and steel round bur. In the teeth included in the study, after opening the access cavity, the coronal pulp was removed with a sharp, sterile excavator and low-speed rotary instrument, and the pulp chamber was rinsed with saline. Primary bleeding control was provided in all groups by applying moisturized sterile cotton pellets over the canal orifices for five minutes with minimal pressure. The teeth in which bleeding could not be controlled within five minutes were excluded from the study, and root canal treatment was performed in these teeth. In the teeth that bleeding control was provided, FS, ABS, or Er,Cr:YSGG laser applications were made according to the order on the randomization list.

Following the primary bleeding control, the FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group. In the laser group, both the physician and the patient wore protective glasses before the procedure. Er,Cr:YSGG laser (Waterlase MD, Biolase, USA) was applied in a non-contact manner on the pulp tissue. In all groups, after secondary bleeding control, the pulp chamber was sealed with zinc oxide -eugenol (ZOE). Glass ionomer cement was applied over the ZOE base and teeth were restored with stainless steel crown. Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.

Conditions

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Pulpal Bleeding; Staining Primary Teeth Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ferric Sulfate

Ferric Sulfate (FS), widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The FS solution was kept in the cavity for 15 seconds using cotton pellets in the FS group.

Group Type ACTIVE_COMPARATOR

Ferric Sulfate (Viskostat; Ultradent, Utah, USA)

Intervention Type DRUG

Widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The metal-protein complex, formed due to contact with blood, creates a mechanical plug; thus, hemostasis occurs without clot formation.

Ankaferd Blood Stopper

Ankaferd Blood Stopper (ABS), recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. The ABS solution drawn from the 1 ml ampoule to the syringe according to the manufacturer's instructions, was kept in the cavity for 15 seconds using cotton pellets in the ABS group.

Group Type EXPERIMENTAL

Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey)

Intervention Type DRUG

Recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. It consists of a standardized mixture of Thymus vulgaris (thyme), Alpinia officinarum (galangal), Vitis vinifera (vine), Glycyrrhiza glabra (licorice) and Urtica dioica (nettle).

Er,Cr:YSGG laser

Er,Cr:YSGG laser was applied in a non-contact manner on the pulp tissue from a distance of 3-4 mm for ten seconds, with an energy intensity of 25 mL, output power of 0.5 W, and frequency of 20 Hz. The MZ6 laser tip was used for application.

Group Type EXPERIMENTAL

Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)

Intervention Type DEVICE

Alternative technique introduced to clinical practice in recent years to provide hemostasis in vital pulp treatment is the usage of lasers in various wavelengths. Using lasers in pulpotomy provides many advantages such as tissue vaporization and coagulation, maintenance of a blood-free working field due to its property to close small blood vessels, minimal clot formation, and sterilization of the wound surface. Furthermore, laser systems were reported to induce cellular biostimulation. Er,Cr:YSGG lasers which belong to the Erbium laser family are the laser systems with the highest absorption rate by water, having a wavelength of 2780 nm. Besides, Erbium lasers manifest bactericidal effects.

Interventions

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Ferric Sulfate (Viskostat; Ultradent, Utah, USA)

Widely used in pulpotomy treatment of primary teeth, provides hemostasis through a chemical reaction with blood. The metal-protein complex, formed due to contact with blood, creates a mechanical plug; thus, hemostasis occurs without clot formation.

Intervention Type DRUG

Ankaferd Blood Stopper (Ankaferd Blood Stopper, Ankaferd Ilaç Kozmetik A.S, Istanbul, Turkey)

Recently introduced to clinical practice as an alternative to FS, is a herbal hemostatic agent. It consists of a standardized mixture of Thymus vulgaris (thyme), Alpinia officinarum (galangal), Vitis vinifera (vine), Glycyrrhiza glabra (licorice) and Urtica dioica (nettle).

Intervention Type DRUG

Er,Cr:YSGG laser (Waterlase MD, Biolase, USA)

Alternative technique introduced to clinical practice in recent years to provide hemostasis in vital pulp treatment is the usage of lasers in various wavelengths. Using lasers in pulpotomy provides many advantages such as tissue vaporization and coagulation, maintenance of a blood-free working field due to its property to close small blood vessels, minimal clot formation, and sterilization of the wound surface. Furthermore, laser systems were reported to induce cellular biostimulation. Er,Cr:YSGG lasers which belong to the Erbium laser family are the laser systems with the highest absorption rate by water, having a wavelength of 2780 nm. Besides, Erbium lasers manifest bactericidal effects.

Intervention Type DEVICE

Other Intervention Names

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Viskostat not Waterlase

Eligibility Criteria

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Inclusion Criteria

* deep dentin caries, lack of spontaneous pain, no sensitivity to percussion and palpation
* no soft tissue pathologies such as edema, fistula, abscess
* mechanical exposure greater than pinpoint, carious exposure,
* suitability for restoration with stainless steel crowns
* healthy lamina dura and periodontal space, no radiographic pathologies in the interradicular and periapical regions, no pathological external and internal resorption, and no calcified masses within the pulp
* mandibular primary molar