UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038072
Receipt number R000043331
Scientific Title Randomized clinical trial of CAREDYNE SHIELD for dentin hypersensitivity
Date of disclosure of the study information 2019/09/22
Last modified on 2022/08/20 07:25:59

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Basic information

Public title

Randomized clinical trial of CAREDYNE SHIELD for dentin hypersensitivity

Acronym

Randomized clinical trial of CAREDYNE SHIELD for dentin hypersensitivity

Scientific Title

Randomized clinical trial of CAREDYNE SHIELD for dentin hypersensitivity

Scientific Title:Acronym

Randomized clinical trial of CAREDYNE SHIELD for dentin hypersensitivity

Region

Japan


Condition

Condition

Dentin hypersensitivity

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effectiveness of CAREDYNE SHIELD for dentin hypersensitivity by comparing with that of Nanoseal

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference between preoperative and 4-weeks postoperative hypersensitivity score (VRS) to air stimuli

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CAREDYNE SHIELD will be applied once according to the manual and 4-weeks follow-up will be performed.

Interventions/Control_2

Nanoseal will be applied once according to the manual and 4-weeks follow-up will be performed.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. outpatients
2. individuals who presented with a hypersensitivity complaint
3. individuals who agreed to attend this study after informed consent

Key exclusion criteria

1. individuals who have hypersensitivity to Zinc, CAREDYNE SHIELD or Nanoseal
2. individuals who presented with not only hypersentivity complaint but also other type of pain complaint
3. pregnant or lactating women
4. presence of caries at dentin-hypersensitivity teeth
5. presence of restoration at the dentin hypersentivity area
6. periodontal surgery and orthodontic treatment to dentine-hypersensitive teeth within the last 3 months
7. dentin-hypersensitivity teeth with advanced periodontal disease
8. treatment of dentin hypersensitivity within the last 6 months
9. presence of systemic conditions that mislead the results of this study (e.g. gastro-oesophageal reflux disease)

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name MATSUURA

Organization

Nagasaki University

Division name

Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences

Zip code

852-8588

Address

852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan

TEL

095-819-7683

Email

matsuurat@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name MATSUURA

Organization

Nagasaki University

Division name

Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sc

Zip code

852-8588

Address

852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan

TEL

095-819-7683

Homepage URL


Email

matsuurat@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

General Affairs Division, Nagasaki University Hospital

Address

852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 22 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32493500/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35843957/

Number of participants that the trial has enrolled

40

Results

From November 2019 to April 2021, 24 participants with 40 teeth were enrolled in this study and 33 teeth in
20 participants were assessed at 4 weeks after treatment. A significant reduction of pain in response to air stimuli was
observed in both groups; however, no significant difference was observed between the groups.

Results date posted

2022 Year 08 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

participants who presented with a complaint of cervical dentine hypersensitivity

Participant flow

Forty CDH teeth which matched the eligibility criteria were randomly allocated to two groups in a 1:1 ratio: the CAREDYNE Shield group (intervention group) and the Nanoseal group (control group). The pain intensity in response to air stimuli, gingival condition, and oral hygiene status of CDH teeth were assessed before and at 4 weeks after treatment.

Adverse events

no harm was observed for any participant in this study.

Outcome measures

The primary outcome was the reduction of pain intensity in response to air stimuli from baseline to 4 weeks after intervention.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 21 Day

Date of IRB

2019 Year 10 Month 22 Day

Anticipated trial start date

2019 Year 11 Month 19 Day

Last follow-up date

2021 Year 04 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 21 Day

Last modified on

2022 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043331


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name