CTRI

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CTRI Number

CTRI/2020/03/024391 [Registered on: 31/03/2020] Trial Registered Prospectively

Last Modified On:

06/01/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Efficiency of remineralising agents on white spots lesions during braces treatment- a controlled clinical trial

Scientific Title of Study

Efficacy of remineralising agents on white spots lesions during fixed orthodontic treatment- a controlled clinical trial

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	priyanka choudhary
Designation	PG 2 year
Affiliation	ITS DENTAL COLLEGE , muradnagar
Address	ITSCDSR dental college, muradnagar delhi-merrut road Ghaziabad Ghaziabad UTTAR PRADESH 201206 India
Phone	09716402593
Fax
Email	cpriyanka864@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Achint Juneja
Designation	Associate Professor
Affiliation	Associate Professor
Address	ITSCDSR dental college muradnagar delhimerrut road Ghaziabad ITSCDSR dental college muradnagar delhimerrut road Ghaziabad Ghaziabad UTTAR PRADESH 201206 India
Phone	9953241381
Fax
Email	achintjuneja@its.edu.in

Details of Contact Person
Public Query

Name	priyanka choudhary
Designation	PG 2 year
Affiliation	ITS DENTAL COLLEGE , muradnagar
Address	ITSCDSR dental college, muradnagar delhi-merrut road Ghaziabad Ghaziabad UTTAR PRADESH 201206 India
Phone	09716402593
Fax
Email	cpriyanka864@gmail.com

Source of Monetary or Material Support

priyanka choudhary ITS CDSR DENTAL COLLEGE DELHIMERRUT ROAD MURADNAGAR GHAZIABAD

Primary Sponsor

Name	Priyanka choudhary
Address	ITS dental college muradnagar delhi merrut road ghaziabad
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 PRIYANKA CHOUDHARY	ITS CDSR DENTALCOLLEGE	ITS dental college orthodontics and dentofacial orthopaedics Ghaziabad UTTAR PRADESH	09716402593 cpriyanka864@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ITS INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K037\|\|Posteruptive color changes of dental hard tissues,

Intervention / Comparator Agent

Type	Name	Details
Intervention	clinpro toothpaste	patient will be adviced to used the clinpro toothpaste for reducing white spot lesions at home only.
Comparator Agent	colgate total tooth paste	patents will be using colgate total tooth paste and its effect on white spot lesions will be checked with diagnodent
Intervention	MI Varnish	MI Varnish is applied on tooth surface in iperatory only for reducing white spot lesions.
Intervention	tooth mint toothpaste	patient will be adviced to use toothmint toothpaste for reducing white spot lesions at home.

Inclusion Criteria

Age From	13.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	no previous fixed orthodontic treatment. permanent dentition. fully erupted anterior teeth. first two month of fixed appliance therapy. no smoking habits

ExclusionCriteria

Details

patients with systemic problems.
enamel hypoplasia.
dental fluorosis.
intrinsic and extrinsic pigmentation.
periodontal problems.
taking antibiotics or any drugs.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
to determine the effects of remineralising agents on white spots lesions.	at 5 month and 8 month after bonding

Secondary Outcome

Outcome	TimePoints
to compare the effect of various remileralising agents on reduction of white spot lesions.	at 5 month and 8 month after bonding

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

01/04/2020

Date of Study Completion (India)

31/12/2020

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

ACTA SCIENTIFIC DENTAL SCIENCES (ISSN:2581-4893) Volume 7 Issue 2 February 2023 RESEARCH ARTICLE

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

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).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.

By what mechanism will data be made available?
Response - Proposals should be directed to [cpriyanka864@gmail.com].

For how long will this data be available start date provided 24-02-2020 and end date provided 24-02-2025?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary
Modification(s)

The study was conducted to determine the efficacy of three different re-mineralising agents on white spots lesions during fixed orthodontic treatment as evaluated using Digital and Visual examination method. In the study, WSLs adjacent to the orthodontic bracket were treated and monitored for a period of 6 months in adolescents who were undergoing orthodontic treatment. Young adults were selected for the study as they can follow the given instructions for using the re-mineralising agents. The total sample included in this study was 86 based on 2 methods i.e. visual examination (ICDAS II Criteria) and digital method (DIAGNODent pen). Teeth without any sign of active white spot lesions i.e. score 5 and 6 on the ICDAS scale, were excluded from the study. Teeth with a score of 2 to 4 on the labial surface as per ICDAS II criteria were selected and further assesed using DIAGNODent pen (Kavo, Germany). Teeth with a score of 0-10 when assesed using a DIAGNODent pen in the labial surface were finally selected.

The selected samples were further randomly into 4 groups- Group 1- Control group, Group 2- MI Varnish, Group 3- Clinpro creme and Group 4- Toothmin toothpaste. all the selected patients were educated and motivate to use the fluoride toothpaste (Colgate Total; 1000 ppm F) two times a day during the study period of 6 months. for patients in MI Varnish group, in-office application of varnish was done at T0. Group 3 and 4 patients were informed to use the respective re-mineralising agents two times a day during the study period of 6 months. Every patients was monitored every month and patients were asked to submit empty tubes of remineralising agents.

Patients were assesed using standard loupes for visual examination and using Diagnodent for digital examination at two intervals i.e. at T0 (at baseline) and T1( after 6 months).

In all the groups, the mean ICDAS II and DIAGNODent scores decreased from baseline (T0) to after 6 months reevaluation (T1) which confirms the efficacy of remineralization agents on the WSLs.