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Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption

NCT ID: NCT05077878

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-14

Study Completion Date

2020-03-12

Brief Summary

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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

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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.

Conditions

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Root Resorption

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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normal

Patients with non-orthodontic treatment and have no root resorption

DSPP level in GCF

Intervention Type BIOLOGICAL

quantification of DSPP

mild to moderate

Patients with orthodontic treatment and have mild to moderate root resorption

DSPP level in GCF

Intervention Type BIOLOGICAL

quantification of DSPP

severe

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

DSPP level in GCF

Intervention Type BIOLOGICAL

quantification of DSPP

Interventions

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DSPP level in GCF

quantification of DSPP

Intervention Type BIOLOGICAL

Other Intervention Names

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Root resorption

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Consumption of anti-inflammatory drugs and antibiotics
Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Rohaya Megat Abdul Wahab

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rohaya Megat Abdul Wahab, Master

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Universiti Kebangsaan Malaysia

Locations

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Faculty of Dentistry

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type DERIVED
PMID: 35488332 (View on PubMed)

Other Identifiers

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UKMfggRMAW

Identifier Type: -

Identifier Source: org_study_id