Tooth MovementNCT04611984
OC and ICTP in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Treatment
A study testing Piezocision in people with Tooth Movement, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Movement
- What is being tested?
- Piezocision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Aug 2014
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I, Class II or Class III malocclusion,
- Proclined incisors requiring extraction of the maxillary first premolars with subsequent retraction of the maxillary canines
- No previous orthodontic treatment
- Good oral hygiene and periodontal health (plaque and gingival indices less or equal 1, probing depth less or equal 3 mm, no radiographic bone loss).
Who cannot join
- having systemic diseases that could affect bone and tooth movement
- smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, 34854
About this study
Official title: Osteocalcin and Cross-Linked C-Terminal Telopeptides of Type I Collagen in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Tooth Movement
The aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid.
Read the detailed description
15 systemically healthy subjects requiring extraction of the maxillary 1. premolars with distalization of the maxillary canines were enrolled to the study. Piezocisions were performed on the distal and mesial sides of the right maxillary canines while the left maxillary canines served as controls. Canine distalization was performed via closed-coil springs applying 150 g of force per side by using miniscrews as anchorage. Gingival crevicular fluid samples were collected from both mesial and distal sides of right and left maxillary canines at 0, 1, 7, 14 and 28 days. The gingival crevicular fluid levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen were determined by using ELISA. The rate of tooth movement was measured on 14 and 28 days.
- Conditions
- Tooth Movement
- Being tested
- Piezocision, Control
- Keywords
- Tooth movement, Piezocision, Gingival crevicular fluid, Osteocalcin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocisionProcedure or surgery
Piezocisions were performed on the mesial and distal sides of the right maxillary canines. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.
ControlProcedure or surgery
The mesial and distal sides of the left maxillary canines served as controls and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.
| Study group | Role | What they receive |
|---|---|---|
| Piezocision | Experimental | Piezocision was performed on the mesial and distal side of the maxillary right canine tooth which was served as the piezocision group. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. Receives: Procedure: Piezocision |
| Control | Active comparator | Maxillary left canine served as the control group and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival crevicular fluid osteocalcin level (ng/ml)
Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of osteocalcin was determined by using ELISA
Measured: 28 days after canine distalization
Gingival crevicular fluid cross-linked C-terminal telopeptides of type I level (ng/ml)
Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of cross-linked C-terminal telopeptides of type I collagen was determined by using ELISA.
Measured: 28 days after canine distalization
Secondary outcomes (2)
The amount of canine movement (mm)
All measurements were performed on the dental cast model using a digital caliper. The amount of space closure was based on the measurements of the distance between the contact points of the distal surface of canine and the mesial surface of second premolar. The change of distance between the three observation periods represented the amount of canine movement.
Measured: Baseline (day 0) before canine distalization and, 14 and 28 days after canine distalization
Retraction rate (mm/day) of canine movement
All measurements were performed on the dental cast model using a digital caliper. The amount of space closure was based on the measurements of the distance between the contact points of the distal surface of canine and the mesial surface of second premolar. The change of distance between the three observation periods represented the amount of canine movement, which was divided by the number of days between two sessions to obtain the retraction rate on daily basis
Measured: 14 and 28 days after canine distalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study startMar 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth MovementStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Selin Yıldırım, Dr., Principal investigator, Marmara University, Faculty of Dentistry, Department of Peridontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611984
- Sponsor's protocol ID
- 04.03.2013.38
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dibart S, Surmenian J, Sebaoun JD, Montesani L. Rapid treatment of Class II malocclusion with piezocision: two case reports. Int J Periodontics Restorative Dent. 2010 Oct;30(5):487-93.
PubMed 20814602Alfaqeeh SA, Anil S. Osteocalcin and N-telopeptides of type I collagen marker levels in gingival crevicular fluid during different stages of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):e553-9. doi: 10.1016/j.ajodo.2011.03.005.
PubMed 21640867Raj SC, Praharaj K, Barik AK, Patnaik K, Mahapatra A, Mohanty D, Katti N, Mishra D, Panda SM. Retraction With and Without Piezocision-Facilitated Orthodontics: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):e19-e26. doi: 10.11607/prd.3968.
PubMed 31815981
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteocalcin and Cross-Linked C-Terminal Telopeptides of Type I Collagen in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT04611984
- Acronym / sponsor ID
- 04.03.2013.38
- Conditions
- Tooth Movement
- Keywords
- Tooth movement, Piezocision, Gingival crevicular fluid, Osteocalcin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Nov 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 aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid.
Detailed description
15 systemically healthy subjects requiring extraction of the maxillary 1. premolars with distalization of the maxillary canines were enrolled to the study. Piezocisions were performed on the distal and mesial sides of the right maxillary canines while the left maxillary canines served as controls. Canine distalization was performed via closed-coil springs applying 150 g of force per side by using miniscrews as anchorage. Gingival crevicular fluid samples were collected from both mesial and distal sides of right and left maxillary canines at 0, 1, 7, 14 and 28 days. The gingival crevicular fluid levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen were determined by using ELISA. The rate of tooth movement was measured on 14 and 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezocision | Experimental | Procedure: PiezocisionPiezocision was performed on the mesial and distal side of the maxillary right canine tooth which was served as the piezocision group. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. |
| Control | Active comparator | Procedure: ControlMaxillary left canine served as the control group and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Class I, Class II or Class III malocclusion,
- Proclined incisors requiring extraction of the maxillary first premolars with subsequent retraction of the maxillary canines
- No previous orthodontic treatment
- Good oral hygiene and periodontal health (plaque and gingival indices less or equal 1, probing depth less or equal 3 mm, no radiographic bone loss).
Key exclusion criteria (2 listed)
- having systemic diseases that could affect bone and tooth movement
- smoking
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 |
|---|---|---|
| PiezocisionPiezocisions were performed on the mesial and distal sides of the right maxillary canines. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. | Procedure or surgery | Piezocision |
| ControlThe mesial and distal sides of the left maxillary canines served as controls and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage. | Procedure or surgery | Control |
Primary outcome
Gingival crevicular fluid osteocalcin level (ng/ml)
Time frame: 28 days after canine distalization
Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of osteocalcin was determined by using ELISA
Gingival crevicular fluid cross-linked C-terminal telopeptides of type I level (ng/ml)
Time frame: 28 days after canine distalization
Gingival crevicular fluid samples were collected from mesial and distal sides of the maxillary right and left canines.The gingival crevicular fluid level of cross-linked C-terminal telopeptides of type I collagen was determined by using ELISA.
2 secondary outcomes
The amount of canine movement (mm)
Time frame: Baseline (day 0) before canine distalization and, 14 and 28 days after canine distalization
Retraction rate (mm/day) of canine movement
Time frame: 14 and 28 days after canine distalization
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 Nov 2020.
- Background: PubMed 20814602Dibart S, Surmenian J, Sebaoun JD, Montesani L. Rapid treatment of Class II malocclusion with piezocision: two case reports. Int J Periodontics Restorative Dent. 2010 Oct;30(5):487-93.
- Background: PubMed 21640867Alfaqeeh SA, Anil S. Osteocalcin and N-telopeptides of type I collagen marker levels in gingival crevicular fluid during different stages of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):e553-9. doi: 10.1016/j.ajodo.2011.03.005.
- Background: PubMed 31815981Raj SC, Praharaj K, Barik AK, Patnaik K, Mahapatra A, Mohanty D, Katti N, Mishra D, Panda SM. Retraction With and Without Piezocision-Facilitated Orthodontics: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):e19-e26. doi: 10.11607/prd.3968.
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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.
Hatice Selin Yıldırım, Dr. principal investigator
Marmara University, Faculty of Dentistry, Department of Peridontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision in people with Tooth Movement, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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 Nov 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 Turkey (Türkiye). 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?
Gingival crevicular fluid osteocalcin level (ng/ml) (time frame: 28 days after canine distalization). The study lists 2 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 NCT04611984, which also lists 3 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 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.