Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152354
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-10-29
Brief Title:
Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth An In Vivo and In Vitro Study
Status:
COMPLETED
Status Verified Date:
2022-10
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:
The teeth were randomly allocated in two equal groups
Control group A- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35
Experimental Group B- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturers instructions
Methods of Evaluation
Stage I - During and after canal preparation- The following parameters were evaluated for all cases in both groups- A- The instrumentation and canal filling time were recorded for both groups using stopwatch B- Radiographic assessment for filling were done immediately postoperative to record -
1 Distance between the apex to filling level of the mesial and distal roots
2 Obturation form
Stage II Follow up
The follow up were carried out by clinical and radiographic evaluation for all cases in both groups-
The clinical evaluation were carried out at 0 base line after 7 days then after 1 3 6 and 12 months
Radiographic evaluation were performed immediately postoperative as 0 baseline after cementation of stainless steel crowns for assessment of filling quality Radiographs will be used for comparison for consequent radiographs Follow ups were performed after 6 and 12 months
Control group A- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35
Experimental Group B- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturers instructions
Methods of Evaluation
Stage I - During and after canal preparation- The following parameters were evaluated for all cases in both groups- A- The instrumentation and canal filling time were recorded for both groups using stopwatch B- Radiographic assessment for filling were done immediately postoperative to record -
1 Distance between the apex to filling level of the mesial and distal roots
2 Obturation form
Stage II Follow up
The follow up were carried out by clinical and radiographic evaluation for all cases in both groups-
The clinical evaluation were carried out at 0 base line after 7 days then after 1 3 6 and 12 months
Radiographic evaluation were performed immediately postoperative as 0 baseline after cementation of stainless steel crowns for assessment of filling quality Radiographs will be used for comparison for consequent radiographs Follow ups were performed after 6 and 12 months
Detailed Description:
The planned study is a randomized clinical controlled trial including apparently healthy children who were selected from the patients attending the Out- Patient Clinic Pediatric Dentistry Department Faculty of Dentistry Suez Canal University Informed written consent were obtained from parents or guardians of the children after full explanation of clinical procedures and detailed treatment plan
The teeth were randomly allocated in two equal groups
Control group A- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35
Experimental Group B- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturers instructions
Clinical procedures
1 Preoperative digital periapical radiograph were taken using standardized paralleling technique using XCP device
2 Local anesthesia were administered to the patient
3 The tooth were isolated using rubber dam
4 Caries were removed by large spoon excavator
5 The cavities were cleaned by thoroughly rinsing with chlorohexidine 02
6 Access cavity were done under constant water cooling and suction using high speed round bur No330
7 Pulp chamber were completely deroofed
8 No 10 size K file were used to determine patency of canals
9 The working length were determined by apex locator periapical radiograph
10 Depending on the group allocation the canal instrumentation were done by step back technique using K- file Mani from size 15 to size 35 in quarter pull turn motion apically or by crown down technique using Kedo-SG file rotary system using endodontic motor
11 - After each instrumentation the canal were irrigated by 1 sodium hypochlorite
12- The canal were dried with paper points 30 35 13- Then canal were filled with creamy mix of Zinc oxide Egenol 14-Zinc phosphate cement were placed over Zinc oxide Egenol then finally restored by Stainless steel crown
15-Postoperative digital periapical radiographs were taken using standardized paralleling technique using XCP device
Methods of Evaluation
Stage I - During and after canal preparation- The following parameters were evaluated for all cases in both groups- A- The instrumentation and canal filling time were recorded for both groups using stopwatch B- Radiographic assessment for filling were done immediately postoperative to record -
1 Distance between the apex to filling level of the mesial and distal roots
2 Obturation form
Stage II Follow up
The follow up were carried out by clinical and radiographic evaluation for all cases in both groups-
The clinical evaluation were carried out at 0 base line after 7 days then after 1 3 6 and 12 months
The following clinical criteria were evaluated -
Spontaneous pain as described by Oginin and Undoye 29
Sensitivity to percussion presence or absence
Tooth mobility presence or absence
Examination of any changes of the mucobuccal folds presence or absence of swelling sinus draining fistula or abscess
If the tooth exhibits any of above clinical features the pulpectomy was considered a failure F otherwise it was regarded as clinical success S
Radiographic evaluation were performed immediately postoperative as 0 baseline after cementation of stainless steel crowns for assessment of filling quality Radiographs will be used for comparison for consequent radiographs Follow ups were performed after 6 and 12 months
The following radiographic criteria were evaluated -
Presence or absence of widening of apical periodontal membrane space
Presence or absence of furcation radioluency
Presence or absence of internal or external root resorption
All patients were examined using standardized intra oral paralleling periapical direct digital radiographs using the rinn XCP periapical film holder and a long cone Radiometric and radiodensitometric analysis of the radiographs were carried out using the software of Digora 25 system
Dates of follow up visits were written on the patient s recall card parents were asked to call if any symptoms of pain or infection occurred at any time before recall visit If there is any complications during follow up periods different techniques of treatment were done according to the case
The teeth were randomly allocated in two equal groups
Control group A- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35
Experimental Group B- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturers instructions
Clinical procedures
1 Preoperative digital periapical radiograph were taken using standardized paralleling technique using XCP device
2 Local anesthesia were administered to the patient
3 The tooth were isolated using rubber dam
4 Caries were removed by large spoon excavator
5 The cavities were cleaned by thoroughly rinsing with chlorohexidine 02
6 Access cavity were done under constant water cooling and suction using high speed round bur No330
7 Pulp chamber were completely deroofed
8 No 10 size K file were used to determine patency of canals
9 The working length were determined by apex locator periapical radiograph
10 Depending on the group allocation the canal instrumentation were done by step back technique using K- file Mani from size 15 to size 35 in quarter pull turn motion apically or by crown down technique using Kedo-SG file rotary system using endodontic motor
11 - After each instrumentation the canal were irrigated by 1 sodium hypochlorite
12- The canal were dried with paper points 30 35 13- Then canal were filled with creamy mix of Zinc oxide Egenol 14-Zinc phosphate cement were placed over Zinc oxide Egenol then finally restored by Stainless steel crown
15-Postoperative digital periapical radiographs were taken using standardized paralleling technique using XCP device
Methods of Evaluation
Stage I - During and after canal preparation- The following parameters were evaluated for all cases in both groups- A- The instrumentation and canal filling time were recorded for both groups using stopwatch B- Radiographic assessment for filling were done immediately postoperative to record -
1 Distance between the apex to filling level of the mesial and distal roots
2 Obturation form
Stage II Follow up
The follow up were carried out by clinical and radiographic evaluation for all cases in both groups-
The clinical evaluation were carried out at 0 base line after 7 days then after 1 3 6 and 12 months
The following clinical criteria were evaluated -
Spontaneous pain as described by Oginin and Undoye 29
Sensitivity to percussion presence or absence
Tooth mobility presence or absence
Examination of any changes of the mucobuccal folds presence or absence of swelling sinus draining fistula or abscess
If the tooth exhibits any of above clinical features the pulpectomy was considered a failure F otherwise it was regarded as clinical success S
Radiographic evaluation were performed immediately postoperative as 0 baseline after cementation of stainless steel crowns for assessment of filling quality Radiographs will be used for comparison for consequent radiographs Follow ups were performed after 6 and 12 months
The following radiographic criteria were evaluated -
Presence or absence of widening of apical periodontal membrane space
Presence or absence of furcation radioluency
Presence or absence of internal or external root resorption
All patients were examined using standardized intra oral paralleling periapical direct digital radiographs using the rinn XCP periapical film holder and a long cone Radiometric and radiodensitometric analysis of the radiographs were carried out using the software of Digora 25 system
Dates of follow up visits were written on the patient s recall card parents were asked to call if any symptoms of pain or infection occurred at any time before recall visit If there is any complications during follow up periods different techniques of treatment were done according to the case
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?:
None
Is an FDA AA801 Violation?:
None