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Completed

NCT Number: NCT05077878

Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

This study was conducted after obtaining approval from UKM Research Ethics Committee. Gingival Crevicular Fluid (GCF) from Orthodontic and non-orthodontic patients was collected with the consent of patients to detect Dentine sialophosphoprotein. Spectrometry analysis of Gingival Crevicular Fluid was conducted in collaboration with MIMOS Berhad.

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Key information

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry

Kuala Lumpur, 50300, Malaysia

About this study

Thirty patients were recruited having met the following inclusion criteria of (1) good general health, (2) good periodontal health, (3) caries-free, (4) good oral hygiene. The subjects were divided into 3 groups based on a radiographic assessment on the level of root resorption; normal (no root resorption), mild (less than 2 mm), and severe (more than 2 mm). The GCF samples were taken from the permanent central incisors of untreated subjects in the normal control group (n=14), while in the mild group, samples were collected from the permanent central incisors with mild root resorption (<2 mm) in patients undergoing active orthodontic treatment after 6 months with radiographic evidence (mild group, n=5). Child patients with severe root resorption (>2 mm) were those with primary second molars undergoing physiological root resorption (severe group, n=11). The GCF samples were collected from the mesial and the distal gingival crevicular sulcus of the involved teeth using gingival fluid collection strips (Periopaper, Oraflow, Smithtown, N.Y.). The paper strips were placed within the sulcus (intrasulcular method) approximately 1 to 2 mm into the gingival sulcus and left in situ for 60 seconds. Every sample collection was taken 3 times at the same site with one-minute resting intervals to allow GCF to be replenished into the gingival sulcus.

Who can participate

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

Inclusion criteria

  • good general health,
  • good periodontal health,
  • caries-free,
  • good oral hygiene

Exclusion criteria

  • Consumption of anti-inflammatory drugs and antibiotics

Treatment and study plan

DSPP level in GCF

Biological

quantification of DSPP

Other names: Root resorption

Primary outcomes

  1. value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption

    Time frame: 1 month

    The absorbance values at a single wavelength at 450 nm

  2. value of wavelength of DSPP in GCF from orthodontic patient with mild to moderate root resorption

    Time frame: 1 month

    The absorbance values at a single wavelength at 450 nm

  3. value of wavelength of DSPP in GCF from child patient severe root resorption

    Time frame: 1 month

    The absorbance values at a single wavelength at 450 nm

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

Dentine Sialophosphoprotein (DSPP) Quantification for Root Resorption Prediction Using Multivariate Versus Univariate Spectrum Analysis

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 14, 2021
Registry last updated
Oct 15, 2021

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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