UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013353
Receipt number R000015338
Scientific Title Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps
Date of disclosure of the study information 2014/03/06
Last modified on 2014/03/06 15:38:36

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Basic information

Public title

Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps

Acronym

Clinical trial study of modSLA Implant

Scientific Title

Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps

Scientific Title:Acronym

Clinical trial study of modSLA Implant

Region

Japan


Condition

Condition

Patients with the single tooth loss in molar or premolar in the maxilla or mandible who are candidate for the dental implantation

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate non-inferiority of the modSLA implant in an early loading procedure (healing period: 25+/-3 days)compared to a conventional loading procedure (healing period: 12-14 weeks) based on crestal bone level change measured at surgery and 6 months(+/-2 weeks) after surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Crestal bone level change at the implant site (mean of mesial and distal measurements) in early and conventional loading procedures measured at 6 months (+/-2 weeks) post implant placement

Key secondary outcomes

1. Evaluation of survival and success rates of indivisual implants
2. Evaluation of crestal bone level change at 12 months ((+/-4 weeks) post-surgery compared to baseline (surgery)
3. Evaluation of patient satisfaction


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Conventional loading

Interventions/Control_2

Early loading

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.Subjects must have voluntarily signed the informed consent form before any study related action
2.Males and females with at least 20 years of age
3.Single tooth gaps in molar or premolar in the mandible or maxilla
4.Adequate oral hygiene level
5.Bone quality I-III and quantity at the implant site to permit the insertion of the modSLA Implant
6.Substantially healed (at least 16 weeks after tooth extraction) extraction sockets

Key exclusion criteria

Systemic exclusion criteria
1. Patients with the systemic disease that would interfere with dental implant therapy (Blood poisoning, weakened immune system, diabetes mellitus, etc--)
2. Patients with the following disease which are applicable to any contraindi-cations or principle contraindications for oral surgery procedures
2-1. Patients who are suffering from a serious internal medical problem such as cardiac infraction or cerebral infraction, uncontrollable endo-crine disorders
2-2. Patients who are suffering from a metabolic bone disease, tem-poromandibular joint disorders, maxillary and mandibular growth not completed, treatable changes in the oral mucosa, local root remnants, xerostomia, patients on bisphosphonate medication
2-3. Patients who are suffering from an inadequate wound healing ca-pacity, prolonged therapy-resistant functional disorders, illnesses re-quiring periodic use of steroids, and who has an irradiation history
2-4. Patients who are having an uncontrolled bleeding disorders, antico-agulation drugs/hemorrhagic diatheses
2-5. Patients who are suffering from psychoses, drug or alcohol abuse, titanium allergy
3. Patients who smoke >10 cigarettes per day
4. Subjects who have participated in another clinical trial within 30 days be-fore obtaining the consent for participating in this trial, or who expect to participate in any other investigational drug or device study during the conduct of this trial
5.Patients who can not follow the instruction from principal investigator or investigator
6.Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results
7.Pregnant or breastfeeding women, and women who desire to get preg-nant during clinical study or who has a possibility of it
8.Patients who are uncooperative

Target sample size

74


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto SHIOTA

Organization

Tokyo Medical and Dental University

Division name

Oral Health Sciences Implant/Masticatory Function Rehabilitation

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-5774

Email

mshiota.impl@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eisaku WATANABE

Organization

Straumann Japan K.K.

Division name

Regulatory&Comliance Clinical Reseach

Zip code


Address

Sapia Tower 16F,1-7-12 Marunouchi,Chiyoda-KU, Tokyo 100-0005, Japan

TEL

03-5218-2613

Homepage URL


Email

eisaku.watanabe@straumann.com


Sponsor or person

Institute

Straumann Japan K.K.

Institute

Department

Personal name



Funding Source

Organization

Straumann Japan K.K.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 03 Month 06 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

Completed

Date of protocol fixation

2010 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 06 Day

Last modified on

2014 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name