Pulpectomy
Conditions
Keywords
EndoArt Pedo Blue, fanta Baby, instrumentation time, obturation quality, pulpectomy using rotary files, rotary files in primary molars
Brief summary
Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality
Interventions
DEVICEPediatric NiTi rotary files manufactured with AF-H Wire technology
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
DEVICEPediatric NiTi rotary files manufactured with blue wire technology
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Cooperative children. 2. Children between the ages of four and eight years. 3. Restorable teeth with irreversible pulpitis. 4. Continuous bleeding after amputation of coronal pulp tissue.
Exclusion criteria
1. Molars that exhibit physiologic root resorption in excess of one-third. 2. Internal and external root resorption. 3. Presence of dental abscess, sinus tract or excessive mobility. 4. Acute spreading infection/cellulitis not manageable with local treatment. 5. Large periapical/furcation lesion with poor prognosis. 6. Teeth close to natural exfoliation. 7. Children with known allergies to study materials or medications used.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| instumentation time | same visit while performing the pulpectomy | The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| obturation quality | same visit after pulpectomy completion | The quality of obturation will be evaluated according to the criteria of Coll and Sadrian criteria (1996). The apical seal will measured in millimeters from the apical end of the canal filling material to the radiographic apex and scored as 1, 2, or 3. 1. Apical seal * Score 1 (Underfilling): was defined as filling in all canals extending more than 2 mm short of the apex. * Score 2 (Ideal filling) was considered when the material reached up to 2 mm short of the radiographic apex or reached the working length in one or more canals. * Score 3 (Overfilling) was recorded when the obturating material extended beyond the radiographic apex. 2. Voids Obturated canals will be assessed for the presence or absence of voids. |
Contacts
CONTACTRania F. Mohamed, bachelor
STUDY_DIRECTORSara A. Mahmoud, Professor
Cairo University
Outcome results
None listed