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CompletedNCT05077878Updated Oct 15, 2021

Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

An observational study in Root Resorption, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 10 Years to 30 Years. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by National University of Malaysia · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
10 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Root Resorption

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Keywords

  • DSPP
03

Who can participate

Ages eligible
10 Years to 30 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients that come to the dental clinic for treatment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Consumption of anti-inflammatory drugs and antibiotics
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • normal

    Patients with non-orthodontic treatment and have no root resorption

    Biological: DSPP level in GCF

  • mild to moderate

    Patients with orthodontic treatment and have mild to moderate root resorption

    Biological: DSPP level in GCF

  • severe

    Child patients with non-orthodontic treatment and have severe root resorption

    Biological: DSPP level in GCF

Interventions

  • BiologicalDSPP level in GCF

    quantification of DSPP

    Also known as: Root resorption

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

  2. 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

    Time frame: 1 month

  3. value of wavelength of DSPP in GCF from child patient severe root resorption

    The absorbance values at a single wavelength at 450 nm

    Time frame: 1 month

06

Study locations

1 site
  • Faculty of Dentistry
    Kuala Lumpur, 50300, Malaysia
07

References and documents

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. PubMed 35488332 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05077878
Lead sponsor
National University of Malaysia
Responsible party
Rohaya Megat Abdul Wahab (Professor, National University of Malaysia) — Principal investigator
First posted
Oct 14, 2021
Start date
Sep 14, 2018
Primary completion
Dec 14, 2019
Completion
Mar 12, 2020
Last update
Oct 15, 2021

Study contacts

Rohaya Megat Abdul Wahab, Master
principal investigator · Faculty of Dentistry, Universiti Kebangsaan Malaysia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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