Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

Root Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077878
• Other study ID #: UKMfggRMAW
• Status: Completed
• Start date: September 14, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: October 2021
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 12, 2020
• Est. primary completion date: December 14, 2019
• Gender: All
• Age group: 10 Years to 30 Years

Eligibility

Inclusion Criteria:

• good general health,

• good periodontal health,

• caries-free,

• good oral hygiene

Exclusion Criteria:

• Consumption of anti-inflammatory drugs and antibiotics

Related Conditions & MeSH terms

• Root Resorption

Intervention

Biological:
• DSPP level in GCF
quantification of DSPP

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption	The absorbance values at a single wavelength at 450 nm	1 month
Primary	value of wavelength of DSPP in GCF from orthodontic patient with mild to moderate root resorption	The absorbance values at a single wavelength at 450 nm	1 month
Primary	value of wavelength of DSPP in GCF from child patient severe root resorption	The absorbance values at a single wavelength at 450 nm	1 month