Study: NCT05619796

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: pulpectomy procedure
Description: single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: pulpectomy procedure
Description: single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: pulpectomy procedure
Description: single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Post-operative Cone Beam Computed Tomography
Description: post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).~The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Post-operative Cone Beam Computed Tomography
Description: post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).~The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Post-operative Cone Beam Computed Tomography
Description: post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).~The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Post-operative pain assessment
Description: The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Post-operative pain assessment
Description: The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Post-operative pain assessment
Description: The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.