Single-file Pulpectomy in Primary Molars

NCT04394702 | Completed

• 1 other identifier: 42/183/11/2016
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpal Necrosis

Keywords

Pulpectomy; Pediatric Dentistry

Outcome Measures

Primary Outcomes (3)

• Pain presence or absence

  score 0 was applied for absence of pain and score 1 was applied for presence of pain

  one year

• swelling presence or absence

  score 0 was applied for absence of swelling and score 1 was applied for presence of swelling

  one year

• 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

Study Arms (2)

One Shape Single-file rotary system

EXPERIMENTAL

Other: One Shape Single-file rotary system

Manual stainless steel K-file

ACTIVE COMPARATOR

Other: manual stainless steel K-file

Interventions

One Shape Single-file rotary system OTHER

rotational single file system used for mechanical debridement of root canals

One Shape Single-file rotary system

manual stainless steel K-file OTHER

sequential manual filing with stainless steel K-files

Manual stainless steel K-file

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University, Faculty of Dentistry.

Minya, 61517, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: June 15, 2017
• Primary Completion: December 22, 2019
• Study Completion: March 2, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

EG (1)