UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026229
Receipt number R000030128
Scientific Title Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis: a randomized controlled clinical trial
Date of disclosure of the study information 2017/02/20
Last modified on 2022/02/24 12:09:54

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Basic information

Public title

Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis: a randomized controlled clinical trial

Acronym

Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis

Scientific Title

Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis: a randomized controlled clinical trial

Scientific Title:Acronym

Efficacy of regenerative surgical therapy using Er: YAG laser for peri-implantitis

Region

Japan


Condition

Condition

Peri-implantitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and compare the efficacy of regenerative surgical therapy for peri-implantitis between Er: YAG laser and mechanical debridement in terms of clinical, microbiological and biochemical aspects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of LPS level before and after the decontamination of affected implant surface.

Key secondary outcomes

Probing pocket depth
Bone level
Bacterial counts in subgingival plaque
Biomarker level in peri-implant crevicular fluid


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Test group (N=12)
Decontamination of affected implant and debridement of granulation tissue around peri-implantitis are made using Er: YAG laser.

Interventions/Control_2

Control group (N=12)
Decontamination of affected implant and debridement of granulation tissue around peri-implantitis are made using ultrasonic scaler and cotton pellet soaked in sterile saline.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Person who obtained written informed
consent.
2.One study implant have at least 2 sites
of probing pocket depth (PPD) greater
than 5 mm with bleeding on probing (BOP)
and more than 3 mm bone loss.

Key exclusion criteria

1.Persons who had received non-surgical
peri-implant therapy within the
previous 3 months
2.Persons who had received surgical
peri-implant therapy within the
previous 6 months
3.Persons who had taken systemic
antibiotics or anti-inflammatory drugs
within 3 months before experiment
4.Acute periodontal burden on the study
implant and the adjacent natural tooth
5.Smoker
6.Persons who had severe systemic
diseases
7.Persons who are pregnant or suspected
to be pregnant
8.Pacemaker or any other systemic
conditions that might be affected by
the Er: YAG laser treatment
9.Persons who are judged to be
unqualified for this study subjects by
investigators.


Target sample size

24


Research contact person

Name of lead principal investigator

1st name Takehiko
Middle name
Last name Kubota

Organization

Niigata University

Division name

Graduate School of Medical and Dental Sciences

Zip code

951-8514

Address

2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan

TEL

025-227-2871

Email

kubota@dent.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yasutaka
Middle name
Last name Komatsu

Organization

Niigata University

Division name

Medical & Dental Hospital

Zip code

951-8514

Address

2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan

TEL

025-227-2871

Homepage URL


Email

komatsu@dent.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

J. Morita Mfg. Corp

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

1. Department of Periodontology, Asahi University, School of Dentistry
2. Department of Periodontology, Osaka Dental University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics review board for clinical research, Niigata University

Address

2-8050, Ikarashi, Nishi-ku, Niigata, 950-2181, Japan

Tel

025-227-2625

Email

ethics@adm.niigata-u.ac.


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

2017 Year 02 Month 20 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

25

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

Completed

Date of protocol fixation

2015 Year 12 Month 10 Day

Date of IRB

2015 Year 05 Month 18 Day

Anticipated trial start date

2016 Year 01 Month 10 Day

Last follow-up date

2021 Year 12 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

2017 Year 02 Month 20 Day

Last modified on

2022 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name