NCT05077878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

September 30, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

DSPP

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

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

quantification of DSPP

Also known as: Root resorption
mild to moderatenormalsevere

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients that come to the dental clinic for treatment

You may qualify if:

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

You may not qualify if:

  • Consumption of anti-inflammatory drugs and antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Rohaya Megat Abdul Wahab, Master

    Faculty of Dentistry, Universiti Kebangsaan Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 14, 2021

Study Start

September 14, 2018

Primary Completion

December 14, 2019

Study Completion

March 12, 2020

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations