Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403306
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-27
Brief Title:
Evaluation of Pulpotomy Success of Different Methods
Sponsor:
Tokat Gaziosmanpasa University
Organization:
Tokat Gaziosmanpasa University
Study Overview
Official Title:
Comparative Evaluation of the Success of ErCrYSGG Laser Pulpotomy With Ferric Sulfate and Ankaferd in Primary Molar Teeth
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Considering the lack of data in the literature concerning the success of ErCrYSGG 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
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 ErCrYSGG 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 manufacturers 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 ErCrYSGG 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
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 manufacturers 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 ErCrYSGG 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None