Root ResorptionNCT03644537
Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.
A study testing Orthodontic intrusion in people with Root Resorption, run by Aya Ahmed Moursi El Faham at 1 site in Egypt.
Trial summary
Since root resorption is a frequent consequence of orthodontic treatment, DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Root Resorption
- What is being tested?
- Orthodontic intrusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2017to Jun 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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent female patients age ranging from 15- 18 yrs, with the full set of the permanent dentition.
- No previous orthodontic treatment.
- Class I crowding or Class II malocclusion whose treatment requires extraction of first maxillary premolars.
- Adequate oral hygiene.
Who cannot join
- Systematic diseases.
- Bad Oral hygiene.
- Missing permanent teeth (except for third molars).
- Uncontrolled Pathological Conditions that may contra-indicate immediate orthodontic treatment (caries, gingivitis, periodontitis).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
economic treatment center, Orthodontics Department, Cairo University
Cairo
Mohamed Amgad Kaddah, Phd in Orthodontics
About this study
Official title: Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces, a Split-mouth Technique, a Randomized Clinical Trial
Since root resorption is a frequent consequence of orthodontic treatment, DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin. Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption
Read the detailed description
Histological and radiographic observations have shown that root resorption is a frequent consequence of orthodontic treatment (Reitan, 1974; Rygh, 1977; Harry and Sims, 1982). In most patients this resorption is minor and of no importance. A few teeth however exhibit severe resorption. In a study by Goldson and Henrikson (1975) it was found that 6 per cent of 924 teeth were resorped more than 2 mm after treatment with a Begg appliance and Malmgren et al. ( 1982) found a similar degree of root resorption in 10 percent of 264 incisors treated with an edgewise appliance and in 5 percent of 176 incisors treated with a Begg appliance(1).
Root resorption resulting from undesirable orthodontic force is an unwanted sequele , that fears all orthodontists including their experts as well(2).
DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin (3,4) .Dentin undergoes continuous deposition throughout life as a secondary dentin only on the pulpal surface. Therefore, these proteins are not routinely released into the surrounding space as dentin does not undergo the process of remodeling as in bone. It is only in the presence of active external root resorption that these proteins could be freed into the periodontal ligament space(5).
Since periapical -intraoral- radiograph gives a two dimensional information, which detect root resorption after 60- 70% of the mineralized tissue is lost. (6) So, it's not sensitive in detecting early root resorption so in this study the investigators introduce the biological marker DSP to monitor root resorption from its onset by collecting samples from the GCF -gingival crevicular fluid- for its detection.
Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption.
- Conditions
- Root Resorption
- Being tested
- Orthodontic intrusion
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic intrusionProcedure or surgery
27 female patients coming to the Orthodontic department, Cairo University seeking orthodontic treatment, where their age ranges from 15 - 18 years, where their treatment plan include extraction of upper first premolars, and using the split-mouth technique, one side will be control group without application of force where the other side will receive intrusive mechanics for the same patient in the upper arch (one side will not receive any force and the same tooth on the other side of the arch will suffer intrusive mechanics, that's why named SPLIT MOUTH TECHNIQUE - as if the arch is split into two subjects, one control subject (tooth) and the other study subject (tooth) . According to the amount of force of the working side, the total number of patients will be divided into 3 groups.
Each of 9 subjects, the first group where a light force will be applied (10 gm), the second group where moderate force will be applied (25gm), the third group where heavy force will be applied(100 gram).
| Study group | Role | What they receive |
|---|---|---|
| heavy force 100gm | Other | heavy intrusive force is to be applied on a first premolar on one side Receives: Procedure: Orthodontic intrusion |
| medium force 25 gm | Other | medium intrusive force is to be applied on a first premolar on one side Receives: Procedure: Orthodontic intrusion |
| light force 10 gm | Other | light intrusive force is to be applied on a first premolar on one side Receives: Procedure: Orthodontic intrusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSP (DentinSialoProtein )
concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption
Measured: with in 3 monthes from applied intrusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start7 Oct 2017
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Ahmed Moursi El Faham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Ahmed Moursi El Faham, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644537
- Sponsor's protocol ID
- CEBD-CU-2018-07-13
- Status last verified
- Aug 2018
- First submitted
- 13 Jul 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces, a Split-mouth Technique, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03644537
- Acronym / sponsor ID
- CEBD-CU-2018-07-13
- Conditions
- Root Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Aya Ahmed Moursi El FahamUniversity, hospital or other
- Study start
- 7 Oct 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Aug 2018 (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.
Since root resorption is a frequent consequence of orthodontic treatment, DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin. Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption
Detailed description
Histological and radiographic observations have shown that root resorption is a frequent consequence of orthodontic treatment (Reitan, 1974; Rygh, 1977; Harry and Sims, 1982). In most patients this resorption is minor and of no importance. A few teeth however exhibit severe resorption. In a study by Goldson and Henrikson (1975) it was found that 6 per cent of 924 teeth were resorped more than 2 mm after treatment with a Begg appliance and Malmgren et al. ( 1982) found a similar degree of root resorption in 10 percent of 264 incisors treated with an edgewise appliance and in 5 percent of 176 incisors treated with a Begg appliance(1).
Root resorption resulting from undesirable orthodontic force is an unwanted sequele , that fears all orthodontists including their experts as well(2).
DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin (3,4) .Dentin undergoes continuous deposition throughout life as a secondary dentin only on the pulpal surface. Therefore, these proteins are not routinely released into the surrounding space as dentin does not undergo the process of remodeling as in bone. It is only in the presence of active external root resorption that these proteins could be freed into the periodontal ligament space(5).
Since periapical -intraoral- radiograph gives a two dimensional information, which detect root resorption after 60- 70% of the mineralized tissue is lost. (6) So, it's not sensitive in detecting early root resorption so in this study the investigators introduce the biological marker DSP to monitor root resorption from its onset by collecting samples from the GCF -gingival crevicular fluid- for its detection.
Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| heavy force 100gm | Other | Procedure: Orthodontic intrusionheavy intrusive force is to be applied on a first premolar on one side |
| medium force 25 gm | Other | Procedure: Orthodontic intrusionmedium intrusive force is to be applied on a first premolar on one side |
| light force 10 gm | Other | Procedure: Orthodontic intrusionlight intrusive force is to be applied on a first premolar on one side |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent female patients age ranging from 15- 18 yrs, with the full set of the permanent dentition.
- No previous orthodontic treatment.
- Class I crowding or Class II malocclusion whose treatment requires extraction of first maxillary premolars.
- Adequate oral hygiene.
Key exclusion criteria (4 listed)
- Systematic diseases.
- Bad Oral hygiene.
- Missing permanent teeth (except for third molars).
- Uncontrolled Pathological Conditions that may contra-indicate immediate orthodontic treatment (caries, gingivitis, periodontitis).
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 |
|---|---|---|
| Orthodontic intrusion27 female patients coming to the Orthodontic department, Cairo University seeking orthodontic treatment, where their age ranges from 15 - 18 years, where their treatment plan include extraction of upper first premolars, and using the split-mouth technique, one side will be control group without application of force where the other side will receive intrusive mechanics for the same patient in the upper arch (one side will not receive any force and the same tooth on the other side of the arch will suffer intrusive mechanics, that's why named SPLIT MOUTH TECHNIQUE - as if the arch is split into two subjects, one control subject (tooth) and the other study subject (tooth) . According to the amount of force of the working side, the total number of patients will be divided into 3 groups. Each of 9 subjects, the first group where a light force will be applied (10 gm), the second group where moderate force will be applied (25gm), the third group where heavy force will be applied(100 gram). | Procedure or surgery | heavy force 100gm, light force 10 gm, medium force 25 gm |
Primary outcome
DSP (DentinSialoProtein )
Time frame: with in 3 monthes from applied intrusion
concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic intrusion in people with Root Resorption, run by Aya Ahmed Moursi El Faham at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya A El Faham, Master student (01099922902, aya.elfaham@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSP (DentinSialoProtein ) (time frame: with in 3 monthes from applied intrusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2018.