Root ResorptionNCT04291443
Proteomics and Orthodontic Root Resorption
A study testing Heavy Force (225g) and Light Force (25g) in people with Root Resorption and Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
The majority of previous studies for early detection of Orthodontically Induced Inflammatory Root Resorption (OIIRR) were conducted to assess individual biomarkers which are representative of single biological pathway. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption, Orthodontic Appliance Complication, Orthodontic Pathological Resorption of External Root
- What is being tested?
- Heavy Force (225g) and Light Force (25g)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2019to 1 Jul 2019
- Phase
- Interventional
- 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 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Orthodontic patients indicated for extraction of bilateral upper first premolars,
- General healthy fit,
- Good oral hygiene with periodontal health maintenance (Plaque Index and Gingival Index ≤1),
- Lack of radiographic signs of idiopathic resorption,
- Radiographically both experimental teeth have two roots with approximately equal length and shape,
- The position of experimental teeth within the arch with no rotation.
Who cannot join
- Patients with impaction except impacted third molars for referral to do CBCT,
- Smokers,
- Patients on anti-inflammatory drugs at least three months before and during the study,
- History of oral habit,
- Previous orthodontic treatment,
- History of dental trauma,
Show all 9Show fewer
- Previous dental treatment of the experimental teeth,
- Patient with heavy occlusion,
- Pathological lesion in the upper arch.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
The majority of previous studies for early detection of Orthodontically Induced Inflammatory Root Resorption (OIIRR) were conducted to assess individual biomarkers which are representative of single biological pathway. To our Knowledge, no studies have been employed Gingival crevicular fluid (GCF) proteomic analysis to identify potential biomarkers for OIIRR. Therefore; the aim of this study is to use the advantage of testing a package of biomarkers via doing proteomic analysis of GCF which could help in making a more precise personalize diagnosis and treatments, thereby providing orthodontists additional information that cannot be deduced from clinical parameters.
Read the detailed description
Orthodontic patients with age range (18-years) indicated for bilateral maxillary first premolars extraction as part of their orthodontic treatment using specific fixed orthodontic appliance design with moderate anchorage were recruited for this study. Both of these premolars were allocated randomly to a heavy ( 225g) and light (25g) force in a split mouth design with a 1:1 allocation ratio. (GCF) was collected from the gingival sulcus of these teeth before extraction at six time intervals which are baseline, 1 hour, 1 day, 1 week , 2 weeks, 3 weeks and 4 weeks. Plaque and Gingival Indices were recorded for those patients at each timeline. Premolars will be extracted after 4weeks to be examined by stereomicroscopy for surface area evaluation of root resorption. Proteomic analysis will be carried out on the GCF sample. The proteomic analysis of the collected GCF will be obtained by using matrix-assisted laser desorption ionization/ time-of-flight mass spectrometry (MALDI-TOF/MS). MS spectra will be used to search human protein sequence data bases for protein identification and the development of "Protein Print" specific for these biological conditions.
- Conditions
- Root Resorption, Orthodontic Appliance Complication, Orthodontic Pathological Resorption of External Root, Gingival Diseases, Tooth Plaque, Tooth Diseases
- Being tested
- Heavy Force (225g), Light Force (25g)
- Keywords
- Proteomic, Orthodontic Root Resorption, Gingival Crevicular Fluid
- Medical subject headings
- Root Resorption, Gingival Diseases, Dental Plaque, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy Force (225g)Procedure or surgery
Orthodontic Force
Light Force (25g)Procedure or surgery
Orthodontic Force
| Study group | Role | What they receive |
|---|---|---|
| Upper First Premolar One Side | Experimental | Heavy force (225 g) Receives: Procedure: Heavy Force (225g) |
| Upper First Premolar Other Side | Experimental | Light Force (25 g) Receives: Procedure: Light Force (25g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of Orthodontic Root Resorption
To monitor change in profiling of GCF proteins associated with orthodontically induced root resorption during 4 weeks after orthodontic force application
Measured: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Secondary outcomes (3)
GCF Flow Rate and Orthodontic Force
To determine the impact of different orthodontic force magnitudes on GCF flow rate
Measured: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Root Resorption Surface Area
To estimate the amount of resorption area in different force groups.
Measured: After 28 days of force application.
Protein concentration in Orthodontic GCF
To evaluate the amount of protein content in GCF of orthodontic patients at different force magnitudes.
Measured: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult orthodontic patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harraa S. Mohammed-Salih, University of Baghdad
- Investigators
- Harraa S. Mohammed-Salih, MSc., Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291443
- Sponsor's protocol ID
- 023418
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saloom HF, Papageorgiou SN, Carpenter GH, Cobourne MT. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study. J Dent Res. 2017 May;96(5):547-554. doi: 10.1177/0022034516688448. Epub 2017 Jan 23.
PubMed 28113000Rody WJ Jr, Holliday LS, McHugh KP, Wallet SM, Spicer V, Krokhin O. Mass spectrometry analysis of gingival crevicular fluid in the presence of external root resorption. Am J Orthod Dentofacial Orthop. 2014 Jun;145(6):787-98. doi: 10.1016/j.ajodo.2014.03.013.
PubMed 24880850
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04291443
- Acronym / sponsor ID
- 023418
- Conditions
- Root Resorption, Orthodontic Appliance Complication, Orthodontic Pathological Resorption of External Root, Gingival Diseases, Tooth Plaque, Tooth Diseases
- Keywords
- Proteomic, Orthodontic Root Resorption, Gingival Crevicular Fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 Mar 2020 (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.
The majority of previous studies for early detection of Orthodontically Induced Inflammatory Root Resorption (OIIRR) were conducted to assess individual biomarkers which are representative of single biological pathway. To our Knowledge, no studies have been employed Gingival crevicular fluid (GCF) proteomic analysis to identify potential biomarkers for OIIRR. Therefore; the aim of this study is to use the advantage of testing a package of biomarkers via doing proteomic analysis of GCF which could help in making a more precise personalize diagnosis and treatments, thereby providing orthodontists additional information that cannot be deduced from clinical parameters.
Detailed description
Orthodontic patients with age range (18-years) indicated for bilateral maxillary first premolars extraction as part of their orthodontic treatment using specific fixed orthodontic appliance design with moderate anchorage were recruited for this study. Both of these premolars were allocated randomly to a heavy ( 225g) and light (25g) force in a split mouth design with a 1:1 allocation ratio. (GCF) was collected from the gingival sulcus of these teeth before extraction at six time intervals which are baseline, 1 hour, 1 day, 1 week , 2 weeks, 3 weeks and 4 weeks. Plaque and Gingival Indices were recorded for those patients at each timeline. Premolars will be extracted after 4weeks to be examined by stereomicroscopy for surface area evaluation of root resorption. Proteomic analysis will be carried out on the GCF sample. The proteomic analysis of the collected GCF will be obtained by using matrix-assisted laser desorption ionization/ time-of-flight mass spectrometry (MALDI-TOF/MS). MS spectra will be used to search human protein sequence data bases for protein identification and the development of "Protein Print" specific for these biological conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Adult orthodontic patients
| Arm | Type | Receives |
|---|---|---|
| Upper First Premolar One Side | Experimental | Procedure: Heavy Force (225g)Heavy force (225 g) |
| Upper First Premolar Other Side | Experimental | Procedure: Light Force (25g)Light Force (25 g) |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Orthodontic patients indicated for extraction of bilateral upper first premolars,
- General healthy fit,
- Good oral hygiene with periodontal health maintenance (Plaque Index and Gingival Index ≤1),
- Lack of radiographic signs of idiopathic resorption,
- Radiographically both experimental teeth have two roots with approximately equal length and shape,
Key exclusion criteria (9 listed)
- Patients with impaction except impacted third molars for referral to do CBCT,
- Smokers,
- Patients on anti-inflammatory drugs at least three months before and during the study,
- History of oral habit,
- Previous orthodontic treatment,
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 |
|---|---|---|
| Heavy Force (225g)Orthodontic Force | Procedure or surgery | Upper First Premolar One Side |
| Light Force (25g)Orthodontic Force | Procedure or surgery | Upper First Premolar Other Side |
Primary outcome
Biomarkers of Orthodontic Root Resorption
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
To monitor change in profiling of GCF proteins associated with orthodontically induced root resorption during 4 weeks after orthodontic force application
3 secondary outcomes
GCF Flow Rate and Orthodontic Force
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Root Resorption Surface Area
Time frame: After 28 days of force application.
Protein concentration in Orthodontic GCF
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
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 2 Mar 2020.
- Background: PubMed 28113000Saloom HF, Papageorgiou SN, Carpenter GH, Cobourne MT. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study. J Dent Res. 2017 May;96(5):547-554. doi: 10.1177/0022034516688448. Epub 2017 Jan 23.
- Background: PubMed 24880850Rody WJ Jr, Holliday LS, McHugh KP, Wallet SM, Spicer V, Krokhin O. Mass spectrometry analysis of gingival crevicular fluid in the presence of external root resorption. Am J Orthod Dentofacial Orthop. 2014 Jun;145(6):787-98. doi: 10.1016/j.ajodo.2014.03.013.
- Orthodontic Root ResorptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Root Resorption
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3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
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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.
Harraa S. Mohammed-Salih, MSc. principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy Force (225g) and Light Force (25g) in people with Root Resorption and Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
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 6 inclusion and 9 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 2 Mar 2020. 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 Iraq. 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?
Biomarkers of Orthodontic Root Resorption (time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days). 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 NCT04291443, which also lists 2 linked publications.
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 2 Mar 2020.