Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

Completed

• Conditions: Root Resorption
• Interventions: Biological: DSPP level in GCF

• Registration Number: NCT05077878
• Lead Sponsor: National University of Malaysia

Brief 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.

Study Timeline

• Study Start: 2018-09-14
• Primary Completion: 2019-12-14
• Study Completion: 2020-03-12
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Consumption of anti-inflammatory drugs and antibiotics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal	DSPP level in GCF	Patients with non-orthodontic treatment and have no root resorption
mild to moderate	DSPP level in GCF	Patients with orthodontic treatment and have mild to moderate root resorption
severe	DSPP level in GCF	Child patients with non-orthodontic treatment and have severe root resorption

Primary Outcome Measures

Name	Time	Method
value of wavelength of DSPP in GCF from child patient severe root resorption	1 month	The absorbance values at a single wavelength at 450 nm
value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption	1 month	The absorbance values at a single wavelength at 450 nm
value of wavelength of DSPP in GCF from orthodontic patient with mild to moderate root resorption	1 month	The absorbance values at a single wavelength at 450 nm

Trial Locations

Locations (1)

Faculty of Dentistry; 🇲🇾 Kuala Lumpur, Malaysia