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Completed

NCT Number: NCT04394702

Single-file Pulpectomy in Primary Molars

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.

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Key information

Conditions

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

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University, Faculty of Dentistry.

Minya, 61517, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One Shape Single-file rotary system

Other

rotational single file system used for mechanical debridement of root canals

manual stainless steel K-file

Other

sequential manual filing with stainless steel K-files

Primary outcomes

  1. Pain presence or absence

    Time frame: one year

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

  2. swelling presence or absence

    Time frame: one year

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

  3. radiographic success or failure

    Time frame: one year

    it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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