UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039831
Receipt number R000045423
Scientific Title Study on filling material for access hole of screw retained implant prosthesis
Date of disclosure of the study information 2020/03/16
Last modified on 2020/03/16 14:18:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on filling material for access hole of screw retained implant prosthesis

Acronym

Materials applied to access holes of implant prostheses

Scientific Title

Study on filling material for access hole of screw retained implant prosthesis

Scientific Title:Acronym

Materials applied to access holes of implant prostheses

Region

Japan


Condition

Condition

Peri-Implantitis

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effect of the material to be filled in the access hole of the screw-retained implant prosthesis on the growth of bacteria and the simplicity of removal from the access hole.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

A cotton ball is used as a material for filling the access hole, but there is a concern that bacteria may grow in the access hole. In recent years, a Teflon tape has been used in place of a cotton ball, and while having excellent sealing properties, it is disadvantageous that it is difficult to remove. Although Parafilm (trade name), a chemically stable paraffin thin film, is not used in the outpatient clinic, it is expected that it has excellent sealing properties and is easy to remove from its properties. It has not been studied whether these two materials (Teflon tape, parafilm) are superior to cotton balls. The purpose of this study is to compare the effect of the material filled in the access hole on the growth of bacteria and the ease of removal from the access hole.

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

Institution is not considered as adjustment factor.

Blocking


Concealment

Pseudo-randomization


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

When installing a screw-retained prosthesis in a subject with more than two implants, the researcher selects three access holes of equal diameter and length. Cotton ball is inserted into each access hole, and the upper portion is closed with a resin-based temporary sealing material (tempofill). After 2-3 weeks, the temporary sealing material is removed, and the material filled in the lower part is recovered, and immediately immersed in sterilized PBS.

Interventions/Control_2

When installing a screw-retained prosthesis in a subject with more than two implants, the researcher selects three access holes of equal diameter and length. Teflon tape is inserted into each access hole, and the upper portion is closed with a resin-based temporary sealing material (tempofill). After 2-3 weeks, the temporary sealing material is removed, and the material filled in the lower part is recovered, and immediately immersed in sterilized PBS.

Interventions/Control_3

When installing a screw-retained prosthesis in a subject with more than two implants, the researcher selects three access holes of equal diameter and length. Parafilm is inserted into each access hole, and the upper part is closed with a resin-based temporary sealing material (tempofill). After 2-3 weeks, the temporary sealing material is removed, and the material filled in the lower part is recovered, and immediately immersed in sterilized PBS.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Three or more implants (Bone Level manufactured by Straumann or Bone Level manufactured by Nobel) are inserted into the outpatient clinic of the University Dental Hospital, and a screw-retained prosthesis is attached and the material in the access hole is removed. Patients with material will remove the materials in the access hole after 2-3 weeks and who agree to be the subjects of this study.

Key exclusion criteria

Smokers

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shohei
Middle name
Last name KASUGAI

Organization

Tokyo Medical and Dental University

Division name

Oral Implantology and Regenerative Dental Medicine

Zip code

113-8510

Address

Tokyo, Bunkyo-ku, Yushima 1-5-45

TEL

03-5803-5934

Email

kas.mfc@tmd.ac.jp


Public contact

Name of contact person

1st name Shohei
Middle name
Last name KASUGAI

Organization

Tokyo Medical and Dental University

Division name

Oral Implantology and Regenerative Dental Medicine

Zip code

113-8510

Address

Tokyo, Bunkyo-ku, Yushima 1-5-45

TEL

03-5803-5934

Homepage URL


Email

kas.mfc@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and dental 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

Tokyo Medical and dental University

Address

Tokyo, Bunkyo-ku, Yushima 1-5-45

Tel

03-5803-5934

Email

kas.mfc@tmd.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

2020 Year 03 Month 16 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2019 Year 12 Month 11 Day

Date of IRB


Anticipated trial start date

2020 Year 03 Month 30 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 16 Day

Last modified on

2020 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045423


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name