Crowding of Anterior Maxillary TeethNCT04950829
Efficacy and Periodontal Parameters in Self-ligating Brackets Alone or With Corticotomy vs Conventional Brackets
A study testing Conventional brackets, Self-ligating brackets and Self-Ligating Brackets with flapless corticotomy in people with Crowding of Anterior Maxillary Teeth, run by Damascus University at 1 site in Syria.
Trial summary
Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic… Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Crowding of Anterior Maxillary Teeth
- What is being tested?
- Conventional brackets, Self-ligating brackets and Self-Ligating Brackets with flapless corticotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSyria
- Study dates
- 8 Aug 2018to 15 Aug 2020
- 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 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars.
- The Little's Index of Irregularity is more than 7 mm.
- Good oral health (plaque Index is less or equal to 1).
- Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0).
- Overbite is between 0-4 mm.
- No skeletal constriction on the upper jaw.
- No congenitally missing or extracted teeth (except for the third molars).
Who cannot join
- Any systemic diseases affect teeth movement.
- Any congenital syndromes or cleft lip and palate.
- Bad oral health.
- The patient is not committed to periodic follow-up times.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus
About this study
Official title: Evaluation of Leveling and Alignment Time and the Periodontal Status in Patients With Severe Upper Crowding Treated by Flapless Corticotomy-assisted Self-ligating Brackets in Comparison With Conventional or Self-Ligating Brackets Alone
Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone.
There are three groups:
Read more
The first group (control group): the patients in this group will be treated using conventional brackets alone.
The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.
The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.
Read the detailed description
The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems.
Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time.
Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.
- Conditions
- Crowding of Anterior Maxillary Teeth
- Being tested
- Conventional brackets, Self-ligating brackets, Self-Ligating Brackets with flapless corticotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional bracketsDevice
These brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets.
Self-ligating bracketsDevice
These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.
Self-Ligating Brackets with flapless corticotomyProcedure or surgery
These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.
Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only.
| Study group | Role | What they receive |
|---|---|---|
| Conventional brackets | Active comparator | Patients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth. Receives: Device: Conventional brackets |
| Self-ligating brackets | Experimental | Patients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth. Receives: Device: Self-ligating brackets |
| 3- Self-Ligating brackets with fapless corticotomy | Experimental | Patients will receive an orthodontic treatment using self-ligating brackets with corticotomy until achieving appropriate alignment of the upper anterior teeth. Receives: Procedure: Self-Ligating Brackets with flapless corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of teeth alignment
The number of days required to finish the alignment stage of upper teeth will be calculated from the beginning of treatment till the end of the alignment stage (i.e. teeth alignment is achieved)
Measured: This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days
Secondary outcomes (4)
The change in the plaque index.
Assessment will be achieved using a gingival probe according to Silness and Loe (1964).
- (0) = No plaque. B. (1) = A film of plaque stick to the free gingival margin and adjacent area of the tooth.
- (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket.
- (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.
Measured: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in the gingival index
Assessment will be achieved using a gingival probe according to Silness and Loe (1964).
- (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing.
- (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing.
- (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding
Measured: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in papillary bleeding index.
Assessment will be achieved using a gingival probe according to Muhlemann (1977).
- (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears.
- (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Measured: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in the probing depth
Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus.
Measured: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start8 Aug 2018
- Primary completion15 Sep 2019
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crowding of Anterior Maxillary TeethStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heba M AL-Ibrahim, DDS, Principal investigator, MSc student at the Orthodontic Department, University of Damascus DentalMohammad Y Hajeer, Study chair, Professor of Orthodontics, University of Damascus Dental School, Damascus, SyriaIssam Khoury, DDS,MSc,PhD, Study director, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950829
- Sponsor's protocol ID
- UDDS-Ortho-05-2021
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergamo AZ, Nelson-Filho P, Romano FL, da Silva RA, Saraiva MC, da Silva LA, Matsumoto MA. Gingival crevicular fluid volume and periodontal parameters alterations after use of conventional and self-ligating brackets. J Orthod. 2016 Dec;43(4):260-267. doi: 10.1080/14653125.2016.1221214. Epub 2016 Sep 8.
PubMed 27607519Chhibber A, Agarwal S, Yadav S, Kuo CL, Upadhyay M. Which orthodontic appliance is best for oral hygiene? A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Feb;153(2):175-183. doi: 10.1016/j.ajodo.2017.10.009.
PubMed 29407494Pandis N, Vlachopoulos K, Polychronopoulou A, Madianos P, Eliades T. Periodontal condition of the mandibular anterior dentition in patients with conventional and self-ligating brackets. Orthod Craniofac Res. 2008 Nov;11(4):211-5. doi: 10.1111/j.1601-6343.2008.00432.x.
PubMed 18950317Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.
PubMed 27891568Mulla Issa FHK, Mulla Issa ZHK, Rabah AF, Hu L. Periodontal parameters in adult patients with clear aligners orthodontics treatment versus three other types of brackets: A cross-sectional study. J Orthod Sci. 2020 Feb 12;9:4. doi: 10.4103/jos.JOS_54_17. eCollection 2020.
PubMed 32166083Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
PubMed 24326120
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leveling and Alignment Time and the Periodontal Status in Patients With Severe Upper Crowding Treated by Flapless Corticotomy-assisted Self-ligating Brackets in Comparison With Conventional or Self-Ligating Brackets Alone
- ClinicalTrials.gov ID
- NCT04950829
- Acronym / sponsor ID
- UDDS-Ortho-05-2021
- Conditions
- Crowding of Anterior Maxillary Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 6 Jul 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.
Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone.
There are three groups:
The first group (control group): the patients in this group will be treated using conventional brackets alone.
The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.
The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.
Detailed description
The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems.
Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time.
Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional brackets | Active comparator | Device: Conventional bracketsPatients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth. |
| Self-ligating brackets | Experimental | Device: Self-ligating bracketsPatients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth. |
| 3- Self-Ligating brackets with fapless corticotomy | Experimental | Procedure: Self-Ligating Brackets with flapless corticotomyPatients will receive an orthodontic treatment using self-ligating brackets with corticotomy until achieving appropriate alignment of the upper anterior teeth. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars.
- The Little's Index of Irregularity is more than 7 mm.
- Good oral health (plaque Index is less or equal to 1).
- Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0).
- Overbite is between 0-4 mm.
Key exclusion criteria (4 listed)
- Any systemic diseases affect teeth movement.
- Any congenital syndromes or cleft lip and palate.
- Bad oral health.
- The patient is not committed to periodic follow-up times.
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 bracketsThese brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets. | Device | Conventional brackets |
| Self-ligating bracketsThese brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets. | Device | Self-ligating brackets |
| Self-Ligating Brackets with flapless corticotomyThese brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets. Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only. | Procedure or surgery | 3- Self-Ligating brackets with fapless corticotomy |
Primary outcome
Duration of teeth alignment
Time frame: This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days
The number of days required to finish the alignment stage of upper teeth will be calculated from the beginning of treatment till the end of the alignment stage (i.e. teeth alignment is achieved)
4 secondary outcomes
The change in the plaque index.
Time frame: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in the gingival index
Time frame: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in papillary bleeding index.
Time frame: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
The change in the probing depth
Time frame: T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months
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 6 Jul 2021.
- Background: PubMed 27607519Bergamo AZ, Nelson-Filho P, Romano FL, da Silva RA, Saraiva MC, da Silva LA, Matsumoto MA. Gingival crevicular fluid volume and periodontal parameters alterations after use of conventional and self-ligating brackets. J Orthod. 2016 Dec;43(4):260-267. doi: 10.1080/14653125.2016.1221214. Epub 2016 Sep 8.
- Background: PubMed 29407494Chhibber A, Agarwal S, Yadav S, Kuo CL, Upadhyay M. Which orthodontic appliance is best for oral hygiene? A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Feb;153(2):175-183. doi: 10.1016/j.ajodo.2017.10.009.
- Background: PubMed 18950317Pandis N, Vlachopoulos K, Polychronopoulou A, Madianos P, Eliades T. Periodontal condition of the mandibular anterior dentition in patients with conventional and self-ligating brackets. Orthod Craniofac Res. 2008 Nov;11(4):211-5. doi: 10.1111/j.1601-6343.2008.00432.x.
- Background: PubMed 27891568Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.
- Background: PubMed 32166083Mulla Issa FHK, Mulla Issa ZHK, Rabah AF, Hu L. Periodontal parameters in adult patients with clear aligners orthodontics treatment versus three other types of brackets: A cross-sectional study. J Orthod Sci. 2020 Feb 12;9:4. doi: 10.4103/jos.JOS_54_17. eCollection 2020.
- Background: PubMed 24326120Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
- Individual participant dataSharing planned: No
Related trials for Crowding of Anterior Maxillary Teeth
Recruiting
Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition
Crowding of Anterior Maxillary Teeth, Orthodontics, Interceptive
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.
Heba M AL-Ibrahim, DDS principal investigator
MSc student at the Orthodontic Department, University of Damascus Dental
Mohammad Y Hajeer study chair
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Issam Khoury, DDS,MSc,PhD study director
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
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 brackets, Self-ligating brackets and Self-Ligating Brackets with flapless corticotomy in people with Crowding of Anterior Maxillary Teeth, run by Damascus University at 1 site in Syria.
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 7 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: finished, as of the sponsor's last update on 6 Jul 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 Syria. 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?
Duration of teeth alignment (time frame: This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days). 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 NCT04950829, which also lists 6 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 6 Jul 2021.