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CTRI Number  CTRI/2021/09/036942 [Registered on: 29/09/2021] Trial Registered Prospectively
Last Modified On: 29/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Space closure in orthodontics using miniscrews 
Scientific Title of Study   Comparative Evaluation of miniscrew assisted rate of enmasse retraction using piezoincision induced and conventional retraction- A clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIBHU PRASAD 
Designation  MDS POST GRADUATE STUDENT 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  PULICKAL HOUSE KAIPUZHA KOTTAYAM,KERALA
COORG INSTITUE OF DENTAL SCIENCES MAGGULA VILLAGE, VIRAJPET TALUK, KODAGU DISTRICT, KARNATAKA.
Kottayam
KERALA
686602
India 
Phone  8754976026  
Fax    
Email  vibhu.prasad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GOUTHAM B 
Designation  PROFESSOR AND HOD 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  COORG INSTITUE OF DENTAL SCIENCES MAGGULA VILLAGE, VIRAJPET TALUK, KODAGU DISTRICT, KARNATAKA.

Kodagu
KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GOUTHAM B 
Designation  PROFESSOR AND HOD 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  COORG INSTITUE OF DENTAL SCIENCES MAGGULA VILLAGE, VIRAJPET TALUK, KODAGU DISTRICT, KARNATAKA.

Kodagu
KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Source of Monetary or Material Support  
COORG INSTITUTE OF DENTAL SCIENCES 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR VIBHU PRASAD  COORG INSTITUTE OF DENTAL SCIENCES  ROOM NO 6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, COORG INSTITUTE OF DENTAL SCIENCES, KANJITHANDA KUSHALAPPA CAMPUS,MAGGULA,VIRAJPETE TALUK, KODAGU DISTRICT 571218 Kodagu KARNATAKA
Kodagu
KARNATAKA 
8754976026

vibhu.prasad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COORG INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diagnosed with Angles Class I malocclusion and no clinical signs of periodontal diseases. 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Retraction  Conventional MBT retraction technique using active tie backs from implants on both sides. Active tie backs were attached from the implants to the post between canine and lateral incisor. Medium pull mini-implant of 1.6mm diameter and 8mm length was used for placement between 2nd premolar and first molar after application of topical anesthesia before retraction 
Intervention  Enmasse retraction using piezoincision induced retraction   Piezocision was performed after the completion of leveling and aligning. A small vertical incision was made using No:15 BP blade on the buccal aspect of teeth, precisely interproximally below the interdental papilla as far as possible in the attached gingiva (central and lateral, lateral and canine, canine and second premolar which is the extraction space). This mid-level incision between the roots of the teeth allowed for insertion of the piezoelectric knife. The tip of the piezotome was inserted to the incision previously made and a 3mm deep piezoelectrical alveolar perforation performed. The perforation passed through the cortical layer and reached the medullary bone to get full effect of regional acceleratory phenomenon (RAP). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Angles class I malocclusion indicated for bilateral maxillary first premolar extraction
2.No clinical signs of periodontal issues
3. No gingivitis or untreated caries
4. No history of periodontal therapy. 
 
ExclusionCriteria 
Details  1.Cases in which Functional appliances, growth modification involved in treatment.
2.Orthognathic surgery was involved in treatment.
3.Patients with Periodontally compromised dentition 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
COMPARITIVE EVALUATION BEFORE AND AFTER ORTHODONTIC TREATMENT  3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
COMPARITIVE EVALUATION BEFORE AND AFTER ORTHODONTIC TREATMENT  3 WEEKS 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-10-2021 and end date provided 01-01-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Orthodontic treatment goal is to improve the patient’s life through enhancement of dentofacial functions and esthetics. The treatment duration is an issue of importance, for the orthodontists and the patients, particularly in adults.1. The demand for speedy, effective and accurate orthodontic treatment systems has increased the need for shorter treatment period. Long orthodontic treatment time poses several limitations like patient burn out, gingivitis, extra hygiene appointments and dental caries. Most of the conventional orthodontic treatments require about two years for completion.2 The search for mechanical orthodontic properties that cause faster and safer tooth movement has been underway with a number of studies on different components like brackets, arch-wires, orthodontic forces, tissue & cellular factors etc. It has been postulated that tooth movement is not only accelerated by the mechanical force but also by the use of pharmaceutical, electromagnetic, laser and surgical stimuli which increases rate of orthodontic tooth movement. Over the years, several surgical techniques have been developed to reduce the overall treatment time.3

                           Corticotomy facilitated tooth movement was first described by L.C. Bryan in 1893.Corticotomy or decortication simply refers to the intentional cutting of cortical bone. Periodontists began using a corticotomy technique to increase the rate of tooth movement. In 1959, Henrich Kole was the first to describe corticotomy assisted orthodontics. Kole believed that it was the thickness of the denser layer of cortical bone that offered the most resistance to tooth movement. Corticotomy acceleration of tooth movement has been reported for several types of tooth movements, including canine retraction, anterior teeth retraction, decrowding, extrusion of impacted canine and third molar uprighting. Although corticotomy procedures are quite effective in assisting acceleration of orthodontic tooth movement, they are inherently invasive because of the requirement for significant flap elevations, which potentially result in postsurgical discomfort and complications that deter patients from undergoing such procedures.4

                           In 1980s, Harold Frost postulated the Rapid Acceleratory Phenomenon (RAP). RAP involves the recruitment of osteoclasts and osteoblasts to the injured site, which leads to a transient localized demineralization-remineralization phenomenon in the bony alveolar housing. Dr. Thomas Wilcko (Periodontist) and William Wilcko (Orthodontist), in 1995 further modified the corticotomy with the addition of alveolar augmentation and named the procedure as Periodontally Accelerated Osteogenic Orthodontics (PAOO) later patented as “Wilckodontics”. Wilcko et al mentioned that corticotomy would increase tooth movement by increasing bone turn over and decreasing bone density.

                               An alternative approach has been introduced by Park et al followed by Kim et al,  the corticision.The technique is a minimally invasive alternative to the creation of surgical injuries to the bone that do not involve flap reflection. Incisions are made directly through the gingiva and bone using a combination of blades and a surgical mallet. While decreasing the surgical time (no flaps or sutures, only cortical incisions), this technique did not offer the benefits of bone grafting to increase periodontal support in the areas where expansive tooth movement was desired.

                                    Vercellotti introduced piezoelectric surgery in 1988 through modifying and improving conventional ultrasound technology. Following that in 2007, Vercellotti and Podesta published their study of ‘monocortical tooth dislocation and ligament distraction’ (MTDLD) technique in which they used piezoelectric surgery to improve and simplify orthodontic therapy in adult patients. Then in 2009, Dibart et al introduced ‘piezocision’ technique as a minimally invasive surgical approach to accelerate orthodontic tooth movement and shorten treatment time.5 This approach combines microincisions to the buccal gingivae that allow for the use of the piezoelectric knife to decorticate the alveolar bone to initiate the regional acceleratory phenomenon. Although it is minimally invasive, it also has the advantage of allowing for hard-tissue or soft-tissue grafting via selective tunneling to correct gingival recessions or bone deficiencies in patients.6 ,7

                               For retracting the anterior teeth and closing space there are two basic biomechanical strategies: frictionless (closing loop mechanics) and friction (sliding) mechanics. Accurate control of anterior teeth during space closure in sliding mechanics is core to the success of orthodontic treatment. When the line of action of force passes below the center of resistance of anterior teeth, a backward moment acts on anterior teeth, resulting in tipping and extrusion of incisors.              The stiffness of the continuous arch wire supports the tooth, keeping it from tipping uncontrollably when a force is placed on it. The tooth will tip until the wire contacts the bracket at opposite corners of the slot, stopping the tipping motion. This contact with the corners of the bracket slot appears to produce a counteracting moment that pulls the root of the tooth in the same direction as the crown moved.

                                Securing appropriate anchorage is an imperative factor for achieving the objectives of orthodontic treatment. Anchorage loss often produces unsatisfactory treatment results, particularly in patients who require maximum anchorage, with a resultant increase in the treatment period. Skeletal anchorage has evolved as a mainstream orthodontic technique with the introduction of temporary anchorage devices. These devices give the clinician an alternative anchorage system instead of conventional extraoral appliances that require full patient compliance. Titanium screws have been used as skeletal anchors because they can provide absolute anchorage without patient cooperation and are useful for various orthodontic tooth movements with minimal anatomic limitations and simpler placement techniques. Orthodontic treatment combined with corticotomy and placement of a temporary anchorage device might have the advantage of shortening the orthodontic treatment period, especially in maximum anchorage situations.

                        However, there is little literature regarding the effects of piezocision. Therefore, the purpose of this study was to assess and compare miniscrew implant-supported en masse retraction with and without piezocision and also to assess the amount of anchorage loss. 

 
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