faculty of dentistry Suez canal university
Ismailia, +202064, Egypt
NCT Number: NCT06152354
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 manufacturer's 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.
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Notify Me4 year–6 year
All sexes
Interventional
Not applicable
Ismailia, +202064, Egypt
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 manufacturer's instructions
Clinical procedures :
11 - After each instrumentation , the canal were irrigated by 1% sodium hypochlorite .
12- The canal were dried with paper points( #30 #) 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 :-
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: -
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 :-
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 (2.5) 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
mandibular primary molars with deep caries indicated for pulpectomy
Exclusion criteria
crown down technique using Kedo-SG file rotary system using endodontic motor
Other names: rotary files
instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically
Other names: hand instrumentation
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
A scale from 1 to 10 where 1 is mild pain and 10 Worst pain
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Time frame: immediately postoperative
recorded for both groups using stopwatch
Time frame: immediately postoperative
Distance between the apex to filling level of the mesial and distal roots . Obturation form
Suez Canal University
Other
Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth: An In Vivo and In Vitro Study
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