Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

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

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.

Study Overview

• Status: Completed
• Conditions: Root Resorption
• Intervention / Treatment: Biological: DSPP level in GCF

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that come to the dental clinic for treatment

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Consumption of anti-inflammatory drugs and antibiotics

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal; Patients with non-orthodontic treatment and have no root resorption	Biological: DSPP level in GCF; quantification of DSPP; Other Names: Root resorption
mild to moderate; Patients with orthodontic treatment and have mild to moderate root resorption	Biological: DSPP level in GCF; quantification of DSPP; Other Names: Root resorption
severe; Child patients with non-orthodontic treatment and have severe root resorption	Biological: DSPP level in GCF; quantification of DSPP; Other Names: Root resorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Rohaya Megat Abdul Wahab, Master, Faculty of Dentistry, Universiti Kebangsaan Malaysia

Publications and helpful links

General Publications

• Mohd Zain MN, Md Yusof Z, Basri KN, Yazid F, Teh YX, Ashari A, Zainal Ariffin SH, Megat Abdul Wahab R. Multivariate versus univariate spectrum analysis of dentine sialophosphoprotein (DSPP) for root resorption prediction: a clinical trial. BMC Oral Health. 2022 Apr 29;22(1):151. doi: 10.1186/s12903-022-02178-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: DSPP
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption; Root Resorption
• Other Study ID Numbers: UKMfggRMAW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No