A clinical trial to study effect of local injection of vitamin D3 on rate of tooth movement in patients undergoing fixed orthodontic treatment.

Not Applicable

Not yet recruiting

Conditions: Anomalies of tooth position of fully erupted tooth or teeth,

Registration Number: CTRI/2020/09/027568

Lead Sponsor: Govt Dental College and Hospital Mumbai

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 subjectâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 11

Inclusion Criteria

Patients with class I malocclusion with bimaxillary protrusion or class II malocclusion who require bimaxillary 1st premolar extraction.
Bimaxillary canine distalisation / retraction.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): govt dental college and hospital mumbai
🇮🇳
Mumbai, MAHARASHTRA, India
govt dental college and hospital mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shreya Koleshwar
Principal investigator
7507404286
shreyakoleshwar257@gmail.com