Evaluation of Pulpotomy Success of Different Methods

May 3, 2024 updated by: NECIBE DAMLA ŞAHIN, Tokat Gaziosmanpasa University

Comparative Evaluation of the Success of Er,Cr:YSGG Laser Pulpotomy With Ferric Sulfate and Ankaferd in Primary Molar Teeth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey
        • Tokat Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria:

  • maxiller primary molar
  • teeth with radiographic pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • Viskostat
Experimental: 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.
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).
Other Names:
  • not
Experimental: 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.
Device: 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.
Other Names:
  • Waterlase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate
Time Frame: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
In clinical examination, treatment was considered unsuccessful when one of the following findings were detected: Spontaneous pain, tenderness to percussion and palpation, fistula formation, soft tissue swelling, and pathological mobility. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
Radiographic success rate
Time Frame: Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.
In the radiological examination, presence of periapical and/or interradicular radiolucency, widening of the periodontal ligament, loss of lamina dura, the presence of internal or external pathological resorption were considered as failure. In teeth in which treatment was considered unsuccessful, root canal treatment or extraction was performed according to the cause of the failure. When indicated, a space maintainer was applied following extraction.
Following the treatment, the patients were called for follow-up examinations at intervals of 3 months for 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Study Director: Volkan Arıkan, Kırıkkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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