| CTRI Number |
CTRI/2020/09/027568 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
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A clinical trial to study effect of local injection of vitamin D3 on rate of tooth movement in patients undergoing fixed orthodontic treatment. |
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Scientific Title of Study
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“ EVALUATION OF EFFECTIVENESS OF LOCALLY INJECTED CALCITRIOL IN ALTERING RATE OF ORTHODONTIC TOOTH MOVEMENT DURING CANINE RETRACTION – RANDOMISED CONTROLLED CLINICAL TRIAL †|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Koleshwar |
| Designation |
MDS student |
| Affiliation |
GDCH Mumbai |
| Address |
Dept of Orthodontics GDCH Mumbai Saint George Hospital Campus Fort Near CSMT Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
7507404286 |
| Fax |
|
| Email |
shreyakoleshwar257@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopinath Kallampilly |
| Designation |
Professor |
| Affiliation |
GDCH Mumbai |
| Address |
Dept of Orthodontics GDCH Mumbai Saint George Hospital Campus Fort Near CSMT Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821167417 |
| Fax |
|
| Email |
gopinath73@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Koleshwar |
| Designation |
MDS student |
| Affiliation |
GDCH Mumbai |
| Address |
Dept of Orthodontics GDCH Mumbai Saint George Hospital Campus Fort Near CSMT Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
7507404286 |
| Fax |
|
| Email |
shreyakoleshwar257@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Orthodontics Govt Dental College and Hospital Saint George Hospital campus Fort Near CSMT Mumbai 400001 |
|
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Primary Sponsor
|
| Name |
Govt Dental College and Hospital Mumbai |
| Address |
Saint George Hospital campus Fort Near CSMT Mumbai 400001 |
| Type of Sponsor |
Other [govt dental college] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Koleshwar |
govt dental college and hospital mumbai |
Department of Orthodontics Room No 206 Saint George Hospital Campus Fort Near CSMT Mumbai 400001
Mumbai
MAHARASHTRA |
7507404286
shreyakoleshwar257@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee government dental college and hospital Mumbai |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
locally injectable calcitriol |
PDL/ intraligamentary injections of calcitriol is to be given locally into the distal side of canines in patients undergoing fixed orthodontic treatment in which 1st premolar extraction is required. Repeat the injection three times for every subject.( 1st ,2nd , & 3rd visits with 15 days of interval between every visit )
After 60 days of 1st injection measure the distance between canine & 2nd
premolar on both Experimental & Control side. |
| Comparator Agent |
Not applicable |
Intraligamentary injection of calcitriol will not be given on control side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with class I malocclusion with bimaxillary protrusion or class II malocclusion who require bimaxillary 1st premolar extraction.
Bimaxillary canine distalisation / retraction |
|
| ExclusionCriteria |
| Details |
Periodontally compromised patients.
No previous history of orthodontic treatment.
Subjects with crowded arches.
Subjects with parafunctional habits such as bruxism, & unilateral chewing pattern.
Subjects with nonvital , endodontically treated teeth, fractured teeth except Ellis class I & class II.
History of chronic drug intake.( anti inflammatory drugs, steroids over the prior 3 months.)
Medically compromised patients |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| rate of orthodontic tooth movement |
pre treatment i.e at the initiation of canine distalization
post treatment i.e 60 days after 1st intraligamentary (PDL) injection of calcitriol |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Periapical & periradicular reaction( root resorption, bone loss , PDL space, continuity of lamina dura) to locally injected calcitriol |
Pre treatment i.e at the initiation of canine distalization
Mid treatment i.e 60 days after 1st intraligamentary (PDL) injection of calcitriol |
|
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Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/09/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Al-Hasani NR, Al-Bustani AI, Ghareeb MM, Hussain SA. Clinical efficacy of locally injected calcitriol in orthodontic tooth movement. Int J Pharm Pharm Sci. 2011;3: 139–143
Abhijith Shetty; Anand K. Patil; Ameet R.; Prabhdeep K. Sandhu. Local infiltration of Vitamin D3 does not accelerate orthodontic tooth movement in humans: A preliminary study. Angle Orthod. 2015. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
A major concern to orthodontic patients is treatment time. The duration of orthodontic treatment may vary according to the severity of the case, extraction versus non-extraction therapy etc. and is indirectly associated with an increased risk of root resorption, gingival inflammation and dental caries making it an equally important concern for the orthodontist. The increased treatment time not only affects the psychological status of the individual but also leads to the teeth prone to severe root resorption, poor oral hygiene, caries and gingival recession. Generally , the time required for fixed appliance treatment is 20 to 30 months. Reducing the treatment time requires increasing the rate of orthodontic tooth movement.Recently several researchers have suggested that there may be ways to increase the cellular activation by use of sources more potent than mechanical forces acting alone. A combination of mechanical, chemical, and perhaps electrical stimuli acting in combination might lead to more rapid bone turnover and hence faster orthodontic tooth movement. These clinical methods range from electro-magneto-mechanical devices to surgical means to pharmacological means. As the clinical studies have shown that local application of calcitriol accelerates tooth movement in animals ; this study is to determine the clinical efficacy of calcitriol in altering rate of tooth movement in humans & thereby altering treatment duration time. REVIEW OF LITERATURE : Monte K. Collins, Peter M. Sinclair in 1988 determined that whether the rate and amount of orthodontic tooth movement in a sample of cats could be enhanced by the injection of a vitamin D metabolite 1,25dihydroxycholecalciferol (1,25D) into the periodontal ligament. This study concluded that at the histologic level, increased numbers of mononuclear osteoclasts were recruited and activated, resulting in greater amounts of alveolar bone resorption on the pressure side of the periodontal ligament. No obvious clinical, microscopic, or biochemical side effects due to vitamin D metabolite injection were noted in this study Selin Kale et al in 2004 ; compared the effects of local administrations of prostaglandin E2 (PGE2) and 1,25-dihydroxycholecalciferol (1,25-DHCC) on orthodontic tooth movement in rats histologically . The results of this study suggest that 1,25-DHCC is more effective in modulating bone turnover during orthodontic tooth movement, because of its well-balanced effects on bone formation and bone resorption. N. R. Al-HASANI et al.; in 2011 studied the clinical efficacy of locally injected vitamin D 3 (calcitriol) in accelerating orthodontic teeth movement (OTM) and reducing treatment time and cost in humans. On clinical efficacy basis, the dose of 25 pg calcitriol produced about 51% faster rate of experimental canine movement compared to control, while each of the 15 pg and 40 pg doses resulted in about 10% accelerated orthodontic tooth movement. Furthermore , the periapical radiographs showed no damaging effect of calcitriol to the surrounding tissues. In conclusion, for the first time it is reported that locally injected calcitriol , in dose dependent pattern, is clinical and cost effective in humans. Abhijith Shetty et al; in 2014 conducted a study to determine the effect of Vitamin D3 on the rate and amount of orthodontic tooth movement in humans when injected locally . In this study, calcitriol is injected locally in the labial vestibule adjacent to canine to be retracted. And concluded that localized infiltration of vitamin D3 produces a significantly decreased rate and amount of tooth movement in humans Aim:- To determine the clinical efficacy of calcitriol in altering rate of orthodontic tooth movement Primary Objectives:- To determine whether local use of calcitriol alters the rate of orthodontic tooth movement. Other objectives :- To check periapical & periradicular reaction( root resorption, bone loss , PDL space, continuity of lamina dura) to locally injected calcitriol METHOD This is split mouth design. Divide each subject’s maxillary arch into left & right as experimental & control side respectively. All subjects will receive preadjusted fixed appliance treatment. After completing alignment phase , anchorage will be reinforced by using transpalatal arches on maxillary 1st molars in all cases. Maxillary canine retraction will start in 2nd phase using distalising force of 150 g as measured by dontrix gauge . Before applying force for retraction of canine measure the distance between canine & 2nd premolar by digital caliper accurate to 0.01mm on both experimental & control side on preretraction casts. Before injecting calcitriol take the IOPA of right & left maxillary canine. On the experimental side , inject 25pg calcitriol in 0.2ml 2% lignocaine containing adrenaline 1:200000. On control side , there will be only conventional orthodontic force. This PDL/ intraligamentary injections is to be given locally into the distal side of canines. Repeat the injection three times for every subject.( 1st ,2nd , & 3rd visits with 15 days of interval between every visit ) After 60 days of 1st injection measure the distance on both Experimental & Control side using digital caliper. Take the IOPA for left & right maxillary canine of each patient to compare the peri apical & peri radicular areas at the control & experimental side. Evaluation of rate of tooth movement on experimental & control side. |