Evaluation of Pulpotomy Success of Different Methods

NCT06403306 | Completed

• 1 other identifier: 2018/08
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpal Bleeding; Staining; Primary Teeth; Pulpotomy

Outcome Measures

Primary Outcomes (2)

• Clinical success rate

  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

  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.

Study Arms (3)

Ferric Sulfate

ACTIVE COMPARATOR

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)

Ankaferd Blood Stopper

EXPERIMENTAL

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)

Er,Cr:YSGG laser

EXPERIMENTAL

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)

Interventions

Ferric Sulfate (Viskostat; Ultradent, Utah, USA) 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.

Also known as: Viskostat

Ferric Sulfate

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

Also known as: not

Ankaferd Blood Stopper

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

Also known as: Waterlase

Er,Cr:YSGG laser

Eligibility Criteria

• Age: 5 Years - 9 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• maxiller primary molar
• teeth with radiographic pathology

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

Related Publications (7)

• Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.

  PMID: 16939452 BACKGROUND

• Vargas KG, Packham B, Lowman D. Preliminary evaluation of sodium hypochlorite for pulpotomies in primary molars. Pediatr Dent. 2006 Nov-Dec;28(6):511-7.

  PMID: 17249432 BACKGROUND

• Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.

  PMID: 18304416 BACKGROUND

• Chandran V, Ramanarayanan V, Menon M, Varma B, Sanjeevan V. Effect of LASER therapy Vs conventional techniques on clinical and radiographic outcomes of deciduous molar pulpotomy: A systematic review and meta-analysis. J Clin Exp Dent. 2020 Jun 1;12(6):e588-e596. doi: 10.4317/jced.56436. eCollection 2020 Jun.

  PMID: 32665819 BACKGROUND

• Cengiz E, Yilmaz HG. Efficacy of Erbium, Chromium-doped:Yttrium, Scandium, Gallium, and Garnet Laser Irradiation Combined with Resin-based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: A Randomized Clinical Trial. J Endod. 2016 Mar;42(3):351-5. doi: 10.1016/j.joen.2015.11.015. Epub 2015 Dec 23.

  PMID: 26723484 BACKGROUND

• Betancourt P, Merlos A, Sierra JM, Camps-Font O, Arnabat-Dominguez J, Vinas M. Effectiveness of low concentration of sodium hypochlorite activated by Er,Cr:YSGG laser against Enterococcus faecalis biofilm. Lasers Med Sci. 2019 Mar;34(2):247-254. doi: 10.1007/s10103-018-2578-6. Epub 2018 Jul 6.

  PMID: 29980946 BACKGROUND

• Fahim SZ, Ghali RM, Hashem AA, Farid MM. The efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in root canal disinfection: A randomized clinical trial. Clin Oral Investig. 2024 Feb 26;28(3):175. doi: 10.1007/s00784-024-05563-z.

  PMID: 38403667 BACKGROUND

MeSH Terms

Interventions

ferric sulfate; ankaferd blood stopper; Nuclear Receptor Subfamily 4, Group A, Member 2

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• Volkan Arıkan

  Kırıkkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 7, 2024
• Study Start: April 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2019
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)