An interventional study of rotary system and Manual files in Pulpitis, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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 :-
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.
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 40 is below the median of 62 across 275 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
mandibular primary molars with deep caries indicated for pulpectomy
Exclusion Criteria:
20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35.
Device: Manual files
20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions .
Device: rotary system
crown down technique using Kedo-SG file rotary system using endodontic motor
Also known as: 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
Also known as: hand instrumentation
Spontaneous Pain
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
Sensitivity to percussion
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
Tooth mobility
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Changes in mucobuccal folds (swelling, abscess or fistula)
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
Radiographic examination " internal or external root resorption"
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Radiographic examination " furcation radiolucency"
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
Radiographic evaluation " widening of apical periodontal membrane space "
Presence (1) or absence (0)
Time frame: baseline (immediately after procedure), after 6 months and 12 months from baseline
The instrumentation and canal filling time
recorded for both groups using stopwatch
Time frame: immediately postoperative
Radiographic assessment
Distance between the apex to filling level of the mesial and distal roots . Obturation form
Time frame: immediately postoperative
Plan to share: No
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Suez Canal University