Clinical trial NCT05077878: Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption
Official title: Dentine Sialophosphoprotein (DSPP) Quantification for Root Resorption Prediction Using Multivariate Versus Univariate Spectrum Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Root Resorption
Keywords: DSPP
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that come to the dental clinic for treatment

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Consumption of anti-inflammatory drugs and antibiotics

Primary outcomes:
measure: value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption
timeFrame: 1 month
measure: value of wavelength of DSPP in GCF from orthodontic patient with mild to moderate root resorption
timeFrame: 1 month
measure: value of wavelength of DSPP in GCF from child patient severe root resorption
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry
Study officials:
affiliation: Faculty of Dentistry, Universiti Kebangsaan Malaysia
name: Rohaya Megat Abdul Wahab, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.