Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06152354
Other study ID # 124/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2022
Est. completion date October 18, 2023

Study information

Verified date October 2022
Source Suez Canal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 manufacturer's 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 0.2% . 6. Access cavity were done under constant water cooling and suction using high speed round bur No.330 . 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 #) 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 (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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 18, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: mandibular primary molars with deep caries indicated for pulpectomy - Restorable lower primary molars. - History of spontaneous pain or pain that is not relieved by analgesics. - Pain with percussion - Excessive bleeding from the root canals Exclusion Criteria: - Allergy to any medications used . - Inability to come in recall visits . mandibular primary molars with exclusion criteria as follows:- - Acute or chronic abscess & fistula. - Inter-radicular or periapical bone destruction (radiolucency) as revealed in the preoperative periapical radiograph . - Mobility grade III. - Internal root resorption.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
rotary system
crown down technique using Kedo-SG file rotary system using endodontic motor
Manual files
instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically

Locations

Country Name City State
Egypt faculty of dentistry Suez canal university Ismailia

Sponsors (1)

Lead Sponsor Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spontaneous Pain A scale from 1 to 10 where 1 is mild pain and 10 Worst pain baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Primary Sensitivity to percussion Presence (1) or Absence (0) baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Primary Tooth mobility Presence (1) or absence (0) baseline (immediately after procedure), after 6 months and 12 months from baseline
Primary Changes in mucobuccal folds (swelling, abscess or fistula) Presence (1) or Absence (0) baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Primary Radiographic examination " internal or external root resorption" Presence (1) or absence (0) baseline (immediately after procedure), after 6 months and 12 months from baseline
Primary Radiographic examination " furcation radiolucency" Presence (1) or absence (0) baseline (immediately after procedure), after 6 months and 12 months from baseline
Primary Radiographic evaluation " widening of apical periodontal membrane space " Presence (1) or absence (0) baseline (immediately after procedure), after 6 months and 12 months from baseline
Secondary The instrumentation and canal filling time recorded for both groups using stopwatch immediately postoperative
Secondary Radiographic assessment Distance between the apex to filling level of the mesial and distal roots . Obturation form immediately postoperative
See also
  Status Clinical Trial Phase
Unknown status NCT00972556 - Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars N/A
Completed NCT04126928 - Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation N/A
Completed NCT02967081 - Evaluation of Dentinal Fluid for the Presence of Matrix Metalloproteinase 9 (MMP-9) in Pulpal Inflammation
Recruiting NCT02745782 - A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment N/A
Completed NCT02681276 - Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment N/A
Completed NCT03490422 - Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors N/A
Completed NCT02940704 - Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems N/A
Completed NCT02566486 - Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study N/A
Completed NCT03168620 - Effect of Glass Ionomer Cement as an Interim Restoration in Diagnosis of Pulpal Status N/A
Completed NCT05476445 - Effect of Cryotherapy and LLLT on Postoperative Pain After Root Canal Treatment N/A
Completed NCT02629042 - Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis Phase 3
Completed NCT04331964 - The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure N/A
Completed NCT04115358 - Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars N/A
Completed NCT03807674 - MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis N/A
Completed NCT01530217 - Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching N/A
Completed NCT05239078 - Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis N/A
Completed NCT02494193 - Indirect Pulp Capping With Resin Modified Glass Ionomer N/A
Completed NCT02819648 - Oral Glucocorticoids Effect on Post Endodontic Pain Phase 4
Completed NCT01420718 - Partial Pulpotomy on Caries Free Human Teeth Phase 2/Phase 3
Completed NCT04385693 - Intentional Pulpotomy to Preserve Hopeless Molars N/A