Clinical Trials Directory

Trials / Completed

CompletedNCT05077878

Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
National University of Malaysia · Academic / Other
Sex
All
Age
10 Years – 30 Years
Healthy volunteers

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDSPP level in GCFquantification of DSPP

Timeline

Start date
2018-09-14
Primary completion
2019-12-14
Completion
2020-03-12
First posted
2021-10-14
Last updated
2021-10-15

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT05077878. Inclusion in this directory is not an endorsement.