An interventional study of Single and two visits pulpectomy in Dental Pulp Necroses, sponsored by Mansoura University. Not yet recruiting. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.
Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.
Clinical and radiographic evaluation for 3 , 6, 12 months
All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.
Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.
In case of single visit pulpectomy (21):
Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.
In case of two visit pulpectomy (13):
First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days.
In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review.
Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.
157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 148 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Necrotic primary molar treated in single visit
Procedure: Single and two visits pulpectomy
Necrotic primary molar treated in two visits
Procedure: Single and two visits pulpectomy
Comparison of clinical and radiographic outcome of Single and two visits pulpectomy
Clinical and Radiographic outcomes
Proportion of clinical and radiographic success in both treatment protocols
Time frame: 3 , 6 and 12 months
No study locations are listed for this record.
Start is estimated for Oct 2023; primary completion for Jan 2024, 3 months later.
Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 3 months is below that.
Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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