Single-file Pulpectomy in Primary Molars

Pulpal Necrosis Clinical Trial

Official title:

Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394702
• Other study ID #: 42/183/11/2016
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: May 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.

This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2, 2020
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children categorized as class I or II according to American Society of Anesthesiologists (ASA).

• Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.

• History of dull toothache over an extended period of time

• History of spontaneous pain or pain at night

• Swelling adjacent to tooth with or without a sinus tract

• Abnormal tooth mobility

• Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed

• Interruption of lamina dura or thickening of periodontal ligament space

• Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor

• Negative findings of internal root resorption

• External root resorption confined to the apical third and with at least two-thirds of the root length was intact

Exclusion Criteria:

• Uncoperative children or parents/legal guardians

• Sever intellectual, behaviour or emotional problems

• Non-restorable tooth crowns

• Root canal obliteration

• Presence of underlying dentigerous or follicular cysts

Related Conditions & MeSH terms

• Necrosis
• Pulpal Necrosis

Intervention

Other:
• One Shape Single-file rotary system
rotational single file system used for mechanical debridement of root canals
• manual stainless steel K-file
sequential manual filing with stainless steel K-files

Locations

Country	Name	City	State
Egypt	Minia University, Faculty of Dentistry.	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain presence or absence	score 0 was applied for absence of pain and score 1 was applied for presence of pain	one year
Primary	swelling presence or absence	score 0 was applied for absence of swelling and score 1 was applied for presence of swelling	one year
Primary	radiographic success or failure	it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency	one year