Root ResorptionNCT05077878
Analysis of Dentine Sialophosphoprotein (DSPP) for Root Resorption
An observational study of Root Resorption, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Root Resorption
- What is being tested?
- DSPP level in GCF
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Sep 2018to 12 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- Child, Adult
Study population: Patients that come to the dental clinic for treatment
Who may be able to join
- good general health,
- good periodontal health,
- caries-free,
- good oral hygiene
Who cannot join
- Consumption of anti-inflammatory drugs and antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dentine Sialophosphoprotein (DSPP) Quantification for Root Resorption Prediction Using Multivariate Versus Univariate Spectrum Analysis
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.
- Conditions
- Root Resorption
- Being tested
- DSPP level in GCF
- Keywords
- DSPP
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSPP level in GCFBiological
Also called Root resorption
quantification of DSPP
| Study group | Role | What they receive |
|---|---|---|
| normal | Patients with non-orthodontic treatment and have no root resorption Receives: Biological: DSPP level in GCF | |
| mild to moderate | Patients with orthodontic treatment and have mild to moderate root resorption Receives: Biological: DSPP level in GCF | |
| severe | Child patients with non-orthodontic treatment and have severe root resorption Receives: Biological: DSPP level in GCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start14 Sep 2018
- Primary completion14 Dec 2019
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohaya Megat Abdul Wahab, National University of Malaysia
- Investigators
- Rohaya Megat Abdul Wahab, Master, Principal investigator, Faculty of Dentistry, Universiti Kebangsaan Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077878
- Sponsor's protocol ID
- UKMfggRMAW
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentine Sialophosphoprotein (DSPP) Quantification for Root Resorption Prediction Using Multivariate Versus Univariate Spectrum Analysis
- ClinicalTrials.gov ID
- NCT05077878
- Acronym / sponsor ID
- UKMfggRMAW
- Conditions
- Root Resorption
- Keywords
- DSPP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal | – | Biological: DSPP level in GCFPatients with non-orthodontic treatment and have no root resorption |
| mild to moderate | – | Biological: DSPP level in GCFPatients with orthodontic treatment and have mild to moderate root resorption |
| severe | – | Biological: DSPP level in GCFChild patients with non-orthodontic treatment and have severe root resorption |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients that come to the dental clinic for treatment
Key inclusion criteria (4 listed)
- good general health,
- good periodontal health,
- caries-free,
- good oral hygiene
Key exclusion criteria (1 listed)
- Consumption of anti-inflammatory drugs and antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSPP level in GCFAlso: Root resorptionquantification of DSPP | Biological | mild to moderate, normal, severe |
Primary outcome
value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption
Time frame: 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
Time frame: 1 month
The absorbance values at a single wavelength at 450 nm
value of wavelength of DSPP in GCF from child patient severe root resorption
Time frame: 1 month
The absorbance values at a single wavelength at 450 nm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 35488332Mohd 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohaya Megat Abdul Wahab, Master principal investigator
Faculty of Dentistry, Universiti Kebangsaan Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Resorption, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of wavelength of DSPP in GCF from non-orthodontic patient with no root resorption (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.