Pocket DepthNCT02436525
Microbial and Periodontal Changes Associated With Conventional Versus Self Ligating Brackets
A study testing conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA) in people with Pocket Depth and Plaque Accumulation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Microbial and periodontal changes associated with conventional versus self ligating brackets. The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pocket Depth, Plaque Accumulation, Gigival Bleeding
- What is being tested?
- conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Apr 2016
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients should satisfy the following criteria:
- Age ranged between 14-18 years.
- All permanent teeth erupted (excluding third molars).
- Angle Class I with normal facial proportion.
- Moderate crowding (from 4 to 6 mm) or irregularity index greater than 4.
- All cases require treatment with fixed appliance with non extraction approach.
Show all 11Show fewer
- Good oral and general health.
- No previous or current periodontal diseases.
- No systemic disease or medication that may interfere with orthodontic teeth movement.
- No history of trauma, bruxism or parafunction.
- No previous orthodontic treatment.
Who cannot join
- Abnormal anteroposterior relationship or steep mandibular plane.
- Crowding more than 6 mm.
- Poor oral hygiene or periodontal affection.
- Uncooperative patients.
- Smoker patients.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, Cairo Governorate
Esam Alhendi, Master, 00201158553005, Esamdentist@yahoo.com
About this study
Official title: Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Microbial and periodontal changes associated with conventional versus self ligating brackets.
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets.
Read the detailed description
Microbial and periodontal changes associated with conventional versus self ligating brackets.
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics
Accumulation of biofilm on the tooth surfaces is associated with increased levels of oral streptococcus mutans and lactobacilli, which have been proved to be responsible for the onset of enamel demineralization and periodontal disease.
It has been shown that fixed appliance provides large number of retentive areas for plaque accumulation and impedes oral hygiene.
Three methods are currently used to connect the arch wire to the brackets, which are : ligation with stainless steel ligatures , using elastomeric ligatures, and the self-ligating brackets. , Each of these method has it's advantages and disadvantages, concerning the biofilm retention and the level of microorganisms. , Orthodontic treatment with conventional brackets my presents some periodontal changes caused by difficulty in oral hygiene maintenance, greater accumulation and qualitative alteration of plaque. Thus, in order to control oral hygiene and plaque level during fixed appliance therapy, manufacturers introduced self-ligating brackets (SLBs) which have been claimed to provide better oral hygiene and less plaque accumulation, because of fewer retentive sites for microbial colonization; without the need for stainless steel and elastomeric ligature. Clinically, the side effects of fixed orthodontic treatment, such as the qualitative bacterial shift, are manifested as plaque associated gingivitis, an increase in pocket probing depth (PPD), and bleeding on probing.
Fewer studies have compared conventional and self-ligating brackets in relation to oral hygiene, microbial count and periodontal indices. Therefore, the present study will be conducted to evaluate and compare microbial and periodontal changes with conventional and self ligating brackets.
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets.
Subjects and method
Study design:
Randomized controlled clinical trial
Study setting and population:
The sample of this study will be consisted of forty five patients selected from Outpatient Clinic, Orthodontic Department, Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University.
Interventions:
The patients will be divided randomly into three groups and will be treated separately as follows:
- Group I: will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature.
- Group II: will be treated using passive self-ligating stainless steel orthodontic brackets.
- Group III: will be treated by active self-ligating stainless steel orthodontic brackets.
Records:
For all patients the following records will be taken before and after treatment:
- Standardized Orthodontic study cast.
- Standardized intra oral and extra oral photographs.
- Standardized panoramic radiograph.
- Standardized lateral cephalometric radiograph.
Observations:
- Periodontal parameters: The following clinical parameters will be recorded at baseline before treatment and at monthly interval for 6 months after bonding;
- Pocket probing depth .
- Plaque index (Silness and Loe) .
- The presence or absence of bleeding on probing .
- Microbial parameters:
Plaque sample will be taken at base line and at monthly interval for six months after bonding. The sample will be taken from the maxillary left canine, second premolar and the right central incisor and the mandibular right canine, second premolar and the left central incisor.
Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted.
Ethical consideration:
All patients will clearly understand the purpose of the study and give their consent by signing an informed consent (attached copy of the consent form).
Patient's instructions:
Instructions form (a copy attached) will be signed by all patients and their parents before commencing the study.
Data management and analysis:BN All the obtained results will be gathered and statistically analyzed using Statistical Package for Social Sciences (SPSS, version 16, Inc., Chicago, Ill).
- Conditions
- Pocket Depth, Plaque Accumulation, Gigival Bleeding
- Being tested
- conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA), active self-ligating stainless steel orthodontic brackets (Oromco - USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)Device
Also called conb
passive self-ligating stainless steel orthodontic brackets (Oromco - USA)Device
Also called pasb
active self-ligating stainless steel orthodontic brackets (Oromco - USA)Device
Also called actb
| Study group | Role | What they receive |
|---|---|---|
| Group I: | Active comparator | will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA.
. Receives: Device: conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA) |
| Group II | Experimental | : will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA. Receives: Device: passive self-ligating stainless steel orthodontic brackets (Oromco - USA) |
| Group III: | Experimental | will be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA . Receives: Device: active self-ligating stainless steel orthodontic brackets (Oromco - USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.
Measured: every month for six months
plaque accumulation
plaque accumulation will be assess using Silness and Loe index
Measured: every month for 6 months after bonding.
Gingival bleeding
Gingival bleeding will be evaluated by the presence or absence of bleeding on probing
Measured: every month for 6 months after bonding.
Composite measure of Microbial parameters
Plaque sample will be taken at base line and at monthly interval for six months after bonding Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted
Measured: every month for 6 months after bonding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pocket DepthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esam Al-hendi, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436525
- Sponsor's protocol ID
- 005OR.
- Status last verified
- Feb 2015
- First submitted
- 19 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
- ClinicalTrials.gov ID
- NCT02436525
- Acronym / sponsor ID
- 005OR.
- Conditions
- Pocket Depth, Plaque Accumulation, Gigival Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- 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.
Microbial and periodontal changes associated with conventional versus self ligating brackets.
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets.
Detailed description
Microbial and periodontal changes associated with conventional versus self ligating brackets.
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics
Accumulation of biofilm on the tooth surfaces is associated with increased levels of oral streptococcus mutans and lactobacilli, which have been proved to be responsible for the onset of enamel demineralization and periodontal disease.
It has been shown that fixed appliance provides large number of retentive areas for plaque accumulation and impedes oral hygiene.
Three methods are currently used to connect the arch wire to the brackets, which are : ligation with stainless steel ligatures , using elastomeric ligatures, and the self-ligating brackets. , Each of these method has it's advantages and disadvantages, concerning the biofilm retention and the level of microorganisms. , Orthodontic treatment with conventional brackets my presents some periodontal changes caused by difficulty in oral hygiene maintenance, greater accumulation and qualitative alteration of plaque. Thus, in order to control oral hygiene and plaque level during fixed appliance therapy, manufacturers introduced self-ligating brackets (SLBs) which have been claimed to provide better oral hygiene and less plaque accumulation, because of fewer retentive sites for microbial colonization; without the need for stainless steel and elastomeric ligature. Clinically, the side effects of fixed orthodontic treatment, such as the qualitative bacterial shift, are manifested as plaque associated gingivitis, an increase in pocket probing depth (PPD), and bleeding on probing.
Fewer studies have compared conventional and self-ligating brackets in relation to oral hygiene, microbial count and periodontal indices. Therefore, the present study will be conducted to evaluate and compare microbial and periodontal changes with conventional and self ligating brackets.
The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets.
Subjects and method
Study design:
Randomized controlled clinical trial
Study setting and population:
The sample of this study will be consisted of forty five patients selected from Outpatient Clinic, Orthodontic Department, Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University.
Interventions:
The patients will be divided randomly into three groups and will be treated separately as follows:
- Group I: will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature.
- Group II: will be treated using passive self-ligating stainless steel orthodontic brackets.
- Group III: will be treated by active self-ligating stainless steel orthodontic brackets.
Records:
For all patients the following records will be taken before and after treatment:
- Standardized Orthodontic study cast.
- Standardized intra oral and extra oral photographs.
- Standardized panoramic radiograph.
- Standardized lateral cephalometric radiograph.
Observations:
- Periodontal parameters: The following clinical parameters will be recorded at baseline before treatment and at monthly interval for 6 months after bonding;
- Pocket probing depth .
- Plaque index (Silness and Loe) .
- The presence or absence of bleeding on probing .
- Microbial parameters:
Plaque sample will be taken at base line and at monthly interval for six months after bonding. The sample will be taken from the maxillary left canine, second premolar and the right central incisor and the mandibular right canine, second premolar and the left central incisor.
Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted.
Ethical consideration:
All patients will clearly understand the purpose of the study and give their consent by signing an informed consent (attached copy of the consent form).
Patient's instructions:
Instructions form (a copy attached) will be signed by all patients and their parents before commencing the study.
Data management and analysis:BN All the obtained results will be gathered and statistically analyzed using Statistical Package for Social Sciences (SPSS, version 16, Inc., Chicago, Ill).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: | Active comparator | Device: conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA. . |
| Group II | Experimental | Device: passive self-ligating stainless steel orthodontic brackets (Oromco - USA): will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA. |
| Group III: | Experimental | Device: active self-ligating stainless steel orthodontic brackets (Oromco - USA)will be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA . |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age ranged between 14-18 years.
- All permanent teeth erupted (excluding third molars).
- Angle Class I with normal facial proportion.
- Moderate crowding (from 4 to 6 mm) or irregularity index greater than 4.
- All cases require treatment with fixed appliance with non extraction approach.
Key exclusion criteria (6 listed)
- Abnormal anteroposterior relationship or steep mandibular plane.
- Crowding more than 6 mm.
- Poor oral hygiene or periodontal affection.
- Uncooperative patients.
- Smoker patients.
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 |
|---|---|---|
| conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)Also: conb | Device | Group I: |
| passive self-ligating stainless steel orthodontic brackets (Oromco - USA)Also: pasb | Device | Group II |
| active self-ligating stainless steel orthodontic brackets (Oromco - USA)Also: actb | Device | Group III: |
Primary outcome
Pocket depth
Time frame: every month for six months
Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.
plaque accumulation
Time frame: every month for 6 months after bonding.
plaque accumulation will be assess using Silness and Loe index
Gingival bleeding
Time frame: every month for 6 months after bonding.
Gingival bleeding will be evaluated by the presence or absence of bleeding on probing
Composite measure of Microbial parameters
Time frame: every month for 6 months after bonding.
Plaque sample will be taken at base line and at monthly interval for six months after bonding Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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 conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA), passive self-ligating stainless steel orthodontic brackets (Oromco - USA) and active self-ligating stainless steel orthodontic brackets (Oromco - USA) in people with Pocket Depth and Plaque Accumulation, run by Al-Azhar University 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 11 inclusion and 6 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 6 May 2015. 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 Esam Al-hendi, Master student (00201158553005, esamdentist@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth (time frame: every month for six months). The study lists 4 primary outcomes in all. 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 6 May 2015.