OC and ICTP in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Treatment
October 30, 2020 updated by: Marmara University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey, 34854
- Marmara University Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- having systemic diseases that could affect bone and tooth movement
- smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Piezocision
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.
|
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.
|
|
Active Comparator: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
28 days after canine distalization
|
|
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.
|
28 days after canine distalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The amount of canine movement (mm)
Time Frame: Baseline (day 0) before canine distalization and, 14 and 28 days after canine distalization
|
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.
|
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
|
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
|
14 and 28 days after canine distalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hatice Selin Yıldırım, Dr., Marmara University, Faculty of Dentistry, Department of Peridontology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Alfaqeeh 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.
- Raj 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 20, 2020
First Submitted That Met QC Criteria
October 30, 2020
First Posted (Actual)
November 2, 2020
Study Record Updates
Last Update Posted (Actual)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 04.03.2013.38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.